A Phase 4 interventional study of Emicizumab in Hemophilia A, sponsored by Genentech, Inc.. Terminated at 8 sites in United States. Per ClinicalTrials.gov, last updated 2021-03-01.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 4, Interventional, and Treatment
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Among 22 studies testing emicizumab in Hemophilia A — 6 open to participants now, 8 under way, 3 of them phase 3. emicizumab · Hemophilia A.
Among the 22 studies testing emicizumab in Hemophilia A, this one is the 18th largest by enrollment, is one of 3 that started in 2018, is one of 6 in phase 4, and was the 7th registered.
844 studies on the registry are indexed under Hemophilia A; 136 are open to participants now.
Browse Hemophilia A studies →6 of the 22 studies testing emicizumab in Hemophilia A are open now, in 4 countries. Recruiting first, the newest first:
Sanofi · Sites in United States, Taiwan
Ages 12+ · Men only
Chulalongkorn University · Sites in Thailand
Ages 3–30 · Men only · Healthy volunteers
Bleeding and Clotting Disorders Institute Peoria, Illinois · Sites in United States
Ages 0–90
Indiana Hemophilia &Thrombosis Center, Inc. · Sites in United States
Ages 5–45 · Men only
Versiti Blood Health · Sites in United States
Ages 0–17
By country, each count listing its studies:
emicizumab: first FDA approval 2017 (HEMLIBRA), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 87 Hemophilia A studies recruiting now, 51 (59%) set no upper age limit and 31 (36%) stop at 75 or younger; 55 take children under 18; 10 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 13 · Phase 4 6
First in 2015; this study’s year is marked. 3 started in 2018.
This study's enrollment of 14 is below the median of 30 across 499 interventional studies indexed under Hemophilia A.
Median enrollment 27 across the 22 interventional studies. Of the 12 that completed or were terminated, 11 (92%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 22 have an industry lead sponsor. The 10 most frequent:
This study is registered under Genentech, Inc., one of the names counted as Hoffmann-La Roche. Under that name alone:
Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.
25 studies in Hemophilia A by Hoffmann-La Roche: 5 open now, 8 under way, 4 of them phase 3. Of 15 finished, 12 (80%) have results posted.
Among the 25 studies in Hemophilia A by Hoffmann-La Roche, this one is the 16th largest by enrollment of the 20 interventional ones that give a count, is one of 4 that started in 2018, is one of 2 in phase 4, and was the 11th registered.
Hoffmann-La Roche’s Hemophilia A studies by the year they started, since 2012.
2 of the studies testing emicizumab in Hemophilia A that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05181618Hoffmann-La RocheA Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis | 2026-11-19 |
| NCT05500807Bleeding and Clotting Disorders Institute Peoria, IllinoisEmicizumab for Severe Von Willebrand Disease (VWD) and VWD/Hemophilia A | 2027-06 |
Add all 2 to your calendar (.ics) → With an account.
Among the 22 studies testing emicizumab in Hemophilia A, from their registry updates:
Among Hoffmann-La Roche’s 25 in Hemophilia A:
This tab as a report to print or save as PDF → With an account.
This Phase IV, multicenter study will evaluate whether participants with Hemophilia A (PwHA) with or without inhibitors receiving emicizumab prophylaxis can safely undergo minor surgical procedures without additional prophylactic bypassing agents (BPA; for participants with inhibitors) or factor VIII (FVIII; for participants without inhibitors).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled but did not have surgery. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
Drug: Emicizumab
This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
Drug: Emicizumab
This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
Drug: Emicizumab
This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
Drug: Emicizumab
This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
Drug: Emicizumab
Emicizumab via SC injection at a loading dose 3 mg/kg once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as the participant continues to derive sufficient benefit. Dosing was to be adjusted if the participant had a significant change in body weight.
Also known as: Hemlibra®, ACE910, RG6013
Percentage of Participants Without Excessive Bleeding at Surgical Sites and Did Not Require BPA/FVIII Use for Bleeding Related to the Surgery, From the Start of Surgery Until Discharge, as Measured by the ISTH Hemostatic Efficacy Scale
The International Society on Thrombosis and Haemostasis (ISTH) Assessment of Hemostatic Response for Surgical Procedures scale (see reference PubMed ID:25059285) has four categories, listed here in order of best to worst response: Excellent, Good, Fair, and Poor. The participant's bleeding related to surgery was evaluated by the healthcare professional who performed the procedure using the hemostatic efficacy scale, with an absence of excessive bleeding at the surgical site indicated by a good to excellent rating. The endpoint was met when the response to "Intraoperative and/or postoperative blood loss increased over expectation for the non-hemophilic patient determined at the time of discharge" was "0 to \<10%" or "10% to \< 25%" AND the response to the question "Did the patient use any bypassing agent (BPA)/factor VIII (FVIII) for the surgery before the discharge?" was "No".
Time frame: Determined at the time of discharge (within approximately 48 hours after surgery)
Percentage of Participants With Excessive Bleeding at Surgical Sites and Required BPA/FVIII Use for Treating Bleeding Related to the Surgery, From the Start of Surgery Until Discharge, as Measured by the ISTH Hemostatic Efficacy Scale
The ISTH Assessment of Hemostatic Response for Surgical Procedures scale (see reference PubMed ID:25059285) has four categories, listed here in order of best to worst response: Excellent, Good, Fair, and Poor. The participant's bleeding related to surgery was evaluated by the healthcare professional who performed the procedure using the hemostatic efficacy scale, with excessive bleeding at the surgical site indicated by a fair to poor rating. The endpoint was met when the response to "Intraoperative and/or postoperative blood loss increased over expectation for the non-hemophilic patient determined at the time of discharge" was "25% to \<50%" or "≥50%" AND the response to the question "Did the patient use any bypassing agent (BPA)/factor VIII (FVIII) for the surgery before the discharge?" was "Yes". The percentage of participants by type and dose of BPA/FVIII used to treat the bleeding is also reported. rFVIIa = recombinant activated human factor VII (eptacog alfa \[activated\])
Time frame: Determined at the time of discharge (within approximately 48 hours after surgery)
Percentage of Participants Who, After Being Discharged From Surgery, Experienced Bleeds That Were Either Related or Unrelated to Surgery and Also Required BPA/FVIII Use
Post-surgical bleeding information was self-reported by participants (or the participant's legally authorized representative) on the "Bleed and Medication Diary". Bypassing agents (BPAs)/factor VIII (FVIII) used to treat excessive bleeding were also self-reported by participants if it was self-administered. BPAs/FVIII administered by the investigators to treat the bleeding were reported on the "Concomitant Medications" case report form page. The percentage of participants by type and dose of BPA/FVIII used to treat the bleeding is also reported. rFVIIa = recombinant activated human factor VII (eptacog alfa \[activated\])
Time frame: Within 48 hours (if discharged home), and 8 and 28 days after surgery
Emicizumab Plasma Concentration on the Day of Surgery
Enrolled participants received a minimum of four loading doses of emicizumab prior to their surgical procedure. Pharmacokinetic blood samples were obtained at study sites 24 hours before the procedures in order to describe emicizumab plasma concentration on the day of surgery for each of the inhibitor and non-inhibitor cohorts.
Time frame: Approximately 24 hours prior to surgery
Safety Summary of the Number of Participants With at Least One Adverse Event
All adverse events (AEs) that occurred after informed consent was obtained were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v23.0, summarized by severity according to the World Health Organization (WHO) toxicity grading scale (Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; Grade 4 is life-threatening; and Grade 5 is death related to AE), and tabulated by body system and preferred term (PT) for individual events within each system organ class (SOC). For each AE, the investigator independently assessed its severity and seriousness, and whether it was considered to be related to the study drug.
Time frame: From Baseline up to 30 days after surgery
Percentage of Participants With Surgical Complications Requiring Hospitalization or Return to Surgery
This safety endpoint was a composite endpoint. Surgical complications were entered as adverse events on the case report form page with "Other suspected causes" marked as "Study Surgery or Procedure". This endpoint was met when response to "It required or prolonged inpatient hospitalization" was checked OR response to "Was procedure/surgery performed?" was "Yes".
Time frame: Within 48 hours after surgery, and 8 and 28 days after initial surgery
Percentage of Participants Who Needed Blood/Blood Product Transfusions During Surgery
The percentage of participants who needed blood or blood product transfusions (e.g., platelets, plasma, etc.) during surgery was evaluated.
Time frame: Within 48 hours after surgery, and 8 and 28 days after initial surgery
| Milestone | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort |
|---|---|---|---|---|---|
| Started | 1 | 9 | 1 | 2 | 1 |
| Completed | 0 | 9 | 1 | 2 | 1 |
| Not completed | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Reason not specified | 1 | 0 | 0 | 0 | 0 |
The International Society on Thrombosis and Haemostasis (ISTH) Assessment of Hemostatic Response for Surgical Procedures scale (see reference PubMed ID:25059285) has four categories, listed here in order of best to worst response: Excellent, Good, Fair, and Poor. The participant's bleeding related to surgery was evaluated by the healthcare professional who performed the procedure using the hemostatic efficacy scale, with an absence of excessive bleeding at the surgical site indicated by a good to excellent rating. The endpoint was met when the response to "Intraoperative and/or postoperative blood loss increased over expectation for the non-hemophilic patient determined at the time of discharge" was "0 to \<10%" or "10% to \< 25%" AND the response to the question "Did the patient use any bypassing agent (BPA)/factor VIII (FVIII) for the surgery before the discharge?" was "No".
| Percentage of participants | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort |
|---|---|---|---|---|---|
| Percentage of Participants Without Excessive Bleeding at Surgical Sites and Did Not Require BPA/FVIII Use for Bleeding Related to the Surgery, From the Start of Surgery Until Discharge, as Measured by the ISTH Hemostatic Efficacy Scale | — | 66.7 | 100.0 | 100.0 | 100.0 |
The ISTH Assessment of Hemostatic Response for Surgical Procedures scale (see reference PubMed ID:25059285) has four categories, listed here in order of best to worst response: Excellent, Good, Fair, and Poor. The participant's bleeding related to surgery was evaluated by the healthcare professional who performed the procedure using the hemostatic efficacy scale, with excessive bleeding at the surgical site indicated by a fair to poor rating. The endpoint was met when the response to "Intraoperative and/or postoperative blood loss increased over expectation for the non-hemophilic patient determined at the time of discharge" was "25% to \<50%" or "≥50%" AND the response to the question "Did the patient use any bypassing agent (BPA)/factor VIII (FVIII) for the surgery before the discharge?" was "Yes". The percentage of participants by type and dose of BPA/FVIII used to treat the bleeding is also reported. rFVIIa = recombinant activated human factor VII (eptacog alfa \[activated\])
| Percentage of participants | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort |
|---|---|---|---|---|---|
| Total with Excessive Bleeding and Received BPA/FVIII | — | 11.1 | 0.0 | 0.0 | 0.0 |
| Treated with 2 mg rFVIIa | — | 11.1 | 0.0 | 0.0 | 0.0 |
Post-surgical bleeding information was self-reported by participants (or the participant's legally authorized representative) on the "Bleed and Medication Diary". Bypassing agents (BPAs)/factor VIII (FVIII) used to treat excessive bleeding were also self-reported by participants if it was self-administered. BPAs/FVIII administered by the investigators to treat the bleeding were reported on the "Concomitant Medications" case report form page. The percentage of participants by type and dose of BPA/FVIII used to treat the bleeding is also reported. rFVIIa = recombinant activated human factor VII (eptacog alfa \[activated\])
| Percentage of participants | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort |
|---|---|---|---|---|---|
| Total with Post-surgical Bleeding and Received BPA/FVIII | — | 22.2 | 100.0 | 0.0 | 0.0 |
| Treated with 2 mg rFVIIa | — | 11.1 | 100.0 | 0.0 | 0.0 |
| Treated with 5 mg rFVIIa | — | 11.1 | 0.0 | 0.0 | 0.0 |
Enrolled participants received a minimum of four loading doses of emicizumab prior to their surgical procedure. Pharmacokinetic blood samples were obtained at study sites 24 hours before the procedures in order to describe emicizumab plasma concentration on the day of surgery for each of the inhibitor and non-inhibitor cohorts.
| micrograms per millilitre (μg/mL) | PwHA With Inhibitors, Emicizumab: All Surgery Cohorts | PwHA Without Inhibitors, Emicizumab: All Surgery Cohorts |
|---|---|---|
| Emicizumab Plasma Concentration on the Day of Surgery | 53.74 ± 28.67 | 38.40 ± 8.95 |
All adverse events (AEs) that occurred after informed consent was obtained were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v23.0, summarized by severity according to the World Health Organization (WHO) toxicity grading scale (Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; Grade 4 is life-threatening; and Grade 5 is death related to AE), and tabulated by body system and preferred term (PT) for individual events within each system organ class (SOC). For each AE, the investigator independently assessed its severity and seriousness, and whether it was considered to be related to the study drug.
| Participants | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort |
|---|---|---|---|---|---|
| Any Adverse Event (AE) | 1 | 4 | 0 | 0 | 0 |
| AE with Fatal Outcome | 0 | 0 | 0 | 0 | 0 |
| Serious Adverse Event (SAE) | 0 | 0 | 0 | 0 | 0 |
| SAE Leading to Withdrawal from Treatment | 0 | 0 | 0 | 0 | 0 |
| SAE Leading to Dose Modification/Interruption | 0 | 0 | 0 | 0 | 0 |
| Related SAE | 0 | 0 | 0 | 0 | 0 |
| AE Leading to Withdrawal from Treatment | 0 | 0 | 0 | 0 | 0 |
| AE Leading to Dose Modification/Interruption | 0 | 0 | 0 | 0 | 0 |
| Related AE | 0 | 0 | 0 | 0 | 0 |
| Related AE Leading to Withdrawal from Treatment | 0 | 0 | 0 | 0 | 0 |
| Related AE Leading to Dose Modification/Interruption | 0 | 0 | 0 | 0 | 0 |
| Grade 3-5 AE | 0 | 0 | 0 | 0 | 0 |
This safety endpoint was a composite endpoint. Surgical complications were entered as adverse events on the case report form page with "Other suspected causes" marked as "Study Surgery or Procedure". This endpoint was met when response to "It required or prolonged inpatient hospitalization" was checked OR response to "Was procedure/surgery performed?" was "Yes".
| Percentage of participants | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort |
|---|---|---|---|---|---|
| Percentage of Participants With Surgical Complications Requiring Hospitalization or Return to Surgery | — | 0.0 | 0.0 | 0.0 | 0.0 |
The percentage of participants who needed blood or blood product transfusions (e.g., platelets, plasma, etc.) during surgery was evaluated.
| Percentage of participants | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort |
|---|---|---|---|---|---|
| Percentage of Participants Who Needed Blood/Blood Product Transfusions During Surgery | — | 0.0 | 0.0 | 0.0 | 0.0 |
Collected over From Baseline up to 30 days after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | 0/9 (0%) | 0/9 (0%) | 4/9 (44.4%) |
| PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 1/1 | 2/9 | 0/1 | 0/2 | 0/1 |
| Limb injuryInjury, poisoning and procedural complications | 1/1 | 0/9 | 0/1 | 0/2 | 0/1 |
| PyrexiaGeneral disorders | 1/1 | 0/9 | 0/1 | 0/2 | 0/1 |
| Device occlusionProduct Issues | 1/1 | 0/9 | 0/1 | 0/2 | 0/1 |
| Procedural painInjury, poisoning and procedural complications | 0/1 | 1/9 | 0/1 | 0/2 | 0/1 |
| ConstipationGastrointestinal disorders | 0/1 | 1/9 | 0/1 | 0/2 | 0/1 |
| AdhesiolysisSurgical and medical procedures | 0/1 | 1/9 | 0/1 | 0/2 | 0/1 |
| HaematomaVascular disorders | 0/1 | 1/9 | 0/1 | 0/2 | 0/1 |
| Age, Customized(Participants) | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort | Total |
|---|---|---|---|---|---|---|
| <18 Years Old | 1 | 7 | 1 | 2 | 0 | 11 |
| ≥18 to <65 Years Old | 0 | 2 | 0 | 0 | 1 | 3 |
| Sex: Female, Male(Participants) | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 1 | 9 | 1 | 2 | 1 | 14 |
| Ethnicity (NIH/OMB)(Participants) | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 1 | 1 | 0 | 5 |
| Not Hispanic or Latino | 1 | 6 | 0 | 1 | 1 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort | PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort | PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort | PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort | Total |
|---|---|---|---|---|---|---|
| Asian | 0 | 1 | 0 | 0 | 0 | 1 |
| Black or African American | 1 | 0 | 0 | 0 | 1 | 2 |
| White | 0 | 5 | 1 | 1 | 0 | 7 |
| Multiple | 0 | 2 | 0 | 0 | 0 | 2 |
| Unknown | 0 | 1 | 0 | 1 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in Mar 2020, 20 months.
Results were first posted in Mar 2021, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Emicizumab