A Phase 2 interventional study of PF-06741086 in Hemophilia A or B, sponsored by Pfizer. Completed at 8 sites in 7 countries. Open to male participants aged 12 Years to 74 Years. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Pfizer · Phase 2, Interventional, and Prevention
This study is designed to evaluate the safety, tolerability and efficacy of long-term treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month Phase 1b/2 B7841002 study. Additionally, de novo subjects will be recruited into this study.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 499 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: PF-06741086
Biological: PF-06741086
Biological: PF-06741086
Biological: PF-06741086
Biological: PF-06741086
Biological: PF-06741086
PF-06741086 subcutaneous injection
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), TEAEs by Severity, and Serious Adverse Events (SAEs) (All Causality and Treatment-Related)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. Grades 3 AEs were severe and undesirable adverse events. Grades 4 AEs were life threatening or disabling adverse events.
Time frame: Day 1 up to Day 393
Number of Participants With Abnormal Laboratory Findings Without Regard to Baseline Abnormality (Including Hematology, Serum Chemistry, and Urinalysis)
Following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The hematology parameters and pre-defined criteria included: neutrophils (10\^3/millimeter\[mm\]\^3) \<0.8\*lower limit of normal (LLN), and basophils (10\^3/mm\^3) \>1.2\*upper limit of normal (ULN). The clinical chemistry parameter and pre-defined criteria included: bilirubin (milligrams \[mg\]/decilitre \[dL\]) \>1.5 ULN, aspartate aminotransferase (units \[U\]/liter \[L\]) \>3.0 ULN, glucose (mg/dL) \>1.5\*ULN. The urinalysis parameter and pre-defined criteria included: urine glucose ≥1, ketones (scalar) ≥1, urine protein ≥1, urine hemoglobin (scalar) ≥1, and hyaline casts per low power field (/LPF). Participants met criteria at any time point were included.
Time frame: Hematology and serum chemistry: Baseline, Days 1, 29, 57, 85, 169, 253, and 365 visits. Urinalysis: Baseline, Days 1, 85, 169, 253, and 365 visits.
Number of Participants With Changes From Baseline in Vital Signs Measurements Meeting the Pre-Defined Categorical Summarization Criteria
Following parameters were analyzed for vital sign examination: blood pressure (BP), pulse rate (PR), temperature, respiration rate. Categorical vital signs: Temperature \>38.5 degree(s) Celsius (℃), Supine PR: \<40 or \>120 beats per minute (BPM), Systolic BP: \<90 mm Hg, \>=30 mm Hg change from baseline, Diastolic BP: \<50 mm Hg, \>=20 mm Hg change from baseline.
Time frame: Baseline, Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 and 393 visits.
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters Meeting the Pre-defined Categorical Summarization Criteria
Baseline was defined as the average of triplicate ECG measurements collected prior to dosing on Day 1 in B7841003. Criteria for potentially clinically important changes in ECG were defined as: PR interval value \>=300 millisecond (msec); PR interval baseline \>200 msec and change \>=25%; PR interval baseline \<=200 msec and change \>=50%; QRS complex value \>=140 msec and change \>=50%; QTcF value \>=450 msec and change \>=30 msec. Only the number of participants meeting pre-defined criteria was reported below.
Time frame: Baseline, Days 1 and 29 visits
Number of Participants With Abnormalities in Physical Examination Findings
Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. For measuring weight, a scale with appropriate range and resolution was used and must have been placed on a stable, flat surface. Participants removed shoes, bulky layers of clothing, and jackets so that only light clothing remains. They also removed the contents of their pockets and remain still during measurement of weight.
Time frame: Day 1 to Day 393
Number of Participants With Injection Site Reactions
Injection site reactions included but were not limited to: erythema, induration, ecchymosis, pain and pruritus. Grade of severity was defined as follows: Mild: Transient or mild discomfort (\< 48 hours); no medical intervention/therapy required. Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible.
Time frame: Day 1 to Day 365, and Day 393 visit.
Annualized Bleeding Rate (ABR)
The ABR was calculated as (\[number of bleeding events × 365.25\] / observed treatment period in days)
Time frame: Day 1 to Day 365, and Day 393 visit. Pre-Treatment summarized the data up to 6 months prior to participation in B7841003 for de novo participants and up to 6 months prior to participation in B7841002 for roll over participants.
| Milestone | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|---|---|---|---|
| Started | 5 | 4 | 4 | 5 | 2 |
| Completed | 5 | 3 | 4 | 4 | 2 |
| Not completed | 0 | 1 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 1 | 0 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. Grades 3 AEs were severe and undesirable adverse events. Grades 4 AEs were life threatening or disabling adverse events.
| Participants | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|---|---|---|---|
| All-causalities TEAE | 5 | 2 | 4 | 2 | 1 |
| Treatment-related TEAE | 2 | 0 | 0 | 0 | 1 |
| All-causalities serious TEAE | 1 | 0 | 0 | 0 | 0 |
| Treatment-related serious TEAE | 0 | 0 | 0 | 0 | 0 |
| All-causalities Grade 3 or 4 TEAE | 1 | 0 | 0 | 0 | 1 |
| Treatment-related Grade 3 or 4 TEAE | 0 | 0 | 0 | 0 | 0 |
Following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The hematology parameters and pre-defined criteria included: neutrophils (10\^3/millimeter\[mm\]\^3) \<0.8\*lower limit of normal (LLN), and basophils (10\^3/mm\^3) \>1.2\*upper limit of normal (ULN). The clinical chemistry parameter and pre-defined criteria included: bilirubin (milligrams \[mg\]/decilitre \[dL\]) \>1.5 ULN, aspartate aminotransferase (units \[U\]/liter \[L\]) \>3.0 ULN, glucose (mg/dL) \>1.5\*ULN. The urinalysis parameter and pre-defined criteria included: urine glucose ≥1, ketones (scalar) ≥1, urine protein ≥1, urine hemoglobin (scalar) ≥1, and hyaline casts per low power field (/LPF). Participants met criteria at any time point were included.
| Participants | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|---|---|---|---|
| Hematology Neutrophils (10^3/mm^3) <0.8*LLN | 1 | 1 | 0 | 0 | 0 |
| Hematology Basophils (10^3/mm^3) >1.2*ULN | 0 | 0 | 0 | 1 | 1 |
| Clinical Chemistry Bilirubin (mg/dL) >1.5*ULN | 0 | 0 | 0 | 0 | 1 |
| Clinical Chemistry Aspartate Aminotransferase (U/L) >3.0*ULN | 0 | 0 | 0 | 0 | 1 |
| Clinical Chemistry Glucose (mg/dL) >1.5*ULN | 0 | 0 | 1 | 1 | 0 |
| Urinalysis URINE Glucose ≥1 | 0 | 0 | 1 | 0 | 0 |
| Urinalysis Ketones (Scalar) ≥1 | 1 | 0 | 0 | 0 | 0 |
| Urinalysis URINE Protein ≥1 | 0 | 1 | 0 | 0 | 0 |
| Urinalysis URINE Hemoglobin (Scalar) ≥1 | 0 | 0 | 1 | 0 | 0 |
| Urinalysis Hyaline Casts (/LPF) >1 | 0 | 1 | 0 | 1 | 0 |
Following parameters were analyzed for vital sign examination: blood pressure (BP), pulse rate (PR), temperature, respiration rate. Categorical vital signs: Temperature \>38.5 degree(s) Celsius (℃), Supine PR: \<40 or \>120 beats per minute (BPM), Systolic BP: \<90 mm Hg, \>=30 mm Hg change from baseline, Diastolic BP: \<50 mm Hg, \>=20 mm Hg change from baseline.
| Participants | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|---|---|---|---|
| Systolic BP (mmHg) < 90 | 0 | 0 | 0 | 0 | 0 |
| Systolic BP Change ≥30 mm Hg increase | 0 | 0 | 1 | 0 | 0 |
| Systolic BP Change ≥30 mm Hg decrease | 0 | 1 | 0 | 1 | 0 |
| Diastolic BP (mmHg) < 50 | 0 | 0 | 0 | 0 | 0 |
| Diastolic BP Change ≥20 mm Hg increase | 1 | 0 | 1 | 1 | 0 |
| Diastolic BP Change ≥20 mm Hg decrease | 0 | 1 | 1 | 1 | 0 |
| Supine PR (BPM) <40 | 0 | 0 | 0 | 0 | 0 |
| Supine PR (BPM) >120 | 0 | 0 | 0 | 0 | 0 |
| Temperature >38.5 ℃ | 0 | 0 | 0 | 0 | 0 |
Baseline was defined as the average of triplicate ECG measurements collected prior to dosing on Day 1 in B7841003. Criteria for potentially clinically important changes in ECG were defined as: PR interval value \>=300 millisecond (msec); PR interval baseline \>200 msec and change \>=25%; PR interval baseline \<=200 msec and change \>=50%; QRS complex value \>=140 msec and change \>=50%; QTcF value \>=450 msec and change \>=30 msec. Only the number of participants meeting pre-defined criteria was reported below.
| Participants | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|
| PR interval value >=300 msec | 0 |
| PR interval baseline >200 msec and Change >=25% | 0 |
| PR interval baseline <=200 msec and change >=50% | 0 |
| QRS complex value >=140 msec | 0 |
| QRS complex change >=50% | 0 |
| 450 <= QTcF Value (msec) < 480 | 0 |
| 480 <= QTcF Value (msec) < 450 | 0 |
| QTcF Value >= 500 msec | 0 |
| 30 <= QTcF Change (msec) < 60 | 0 |
| QTcF Change >= 60 msec | 0 |
Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. For measuring weight, a scale with appropriate range and resolution was used and must have been placed on a stable, flat surface. Participants removed shoes, bulky layers of clothing, and jackets so that only light clothing remains. They also removed the contents of their pockets and remain still during measurement of weight.
| Participants | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|---|---|---|---|
| Number of Participants With Abnormalities in Physical Examination Findings | 5 | 2 | 3 | 4 | 2 |
Injection site reactions included but were not limited to: erythema, induration, ecchymosis, pain and pruritus. Grade of severity was defined as follows: Mild: Transient or mild discomfort (\< 48 hours); no medical intervention/therapy required. Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible.
| Participants | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|---|---|---|---|
| Erythema (redness) Mild | 0 | 0 | 0 | 0 | 0 |
| Erythema (redness) Moderate | 0 | 0 | 0 | 0 | 0 |
| Erythema (redness) Severe | 0 | 0 | 0 | 0 | 1 |
| Induration (swelling) Mild | 1 | 0 | 0 | 0 | 0 |
| Induration (swelling) Moderate | 0 | 0 | 0 | 0 | 0 |
| Induration (swelling) Severe | 0 | 0 | 0 | 0 | 1 |
| Ecchymosis (bruising) Mild | 1 | 0 | 0 | 0 | 0 |
| Ecchymosis (bruising) Moderate | 0 | 0 | 0 | 0 | 0 |
| Ecchymosis (bruising) Severe | 0 | 0 | 0 | 0 | 0 |
| Pain (after injection) Mild | 1 | 0 | 0 | 0 | 0 |
| Pain (after injection) Moderate | 0 | 0 | 0 | 0 | 0 |
| Pain (after injection) Severe | 0 | 0 | 0 | 0 | 0 |
| Pruritus (itching) Mild | 1 | 0 | 0 | 0 | 0 |
| Pruritus (itching) Moderate | 0 | 0 | 0 | 0 | 0 |
| Pruritus (itching) Severe | 0 | 0 | 0 | 0 | 0 |
| Other Mild | 1 | 0 | 0 | 0 | 0 |
| Other Moderate | 0 | 0 | 0 | 0 | 0 |
| Other Severe | 0 | 0 | 0 | 0 | 1 |
| Any injection site reaction Mild | 2 | 0 | 0 | 0 | 0 |
| Any injection site reaction Moderate | 0 | 0 | 0 | 0 | 0 |
| Any injection site reaction Severe | 0 | 0 | 0 | 0 | 1 |
The ABR was calculated as (\[number of bleeding events × 365.25\] / observed treatment period in days)
| Bleeding episodes/participant/year | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|---|---|---|---|
| Pre-Treatment | 22.000 ± 7.8740 | 14.000 ± 1.6330 | 22.000 ± 13.5647 | 18.400 ± 1.6733 | 15.000 ± 4.2426 |
| On-Study | 2.971 ± 2.7895 | 3.586 ± 7.1726 | 1.916 ± 1.4492 | 0.000 ± 0.0000 | 2.488 ± 3.5187 |
Collected over Day 1 up to Day 393. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: 300mg - 300mg Non-Inhibitor | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Cohort 4: 300mg - 300mg Inhibitor | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Event | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|---|---|---|---|
| Cerebral haemorrhageNervous system disorders | 1/5 | 0/4 | 0/4 | 0/5 | 0/2 |
| Generalised tonic-clonic seizureNervous system disorders | 1/5 | 0/4 | 0/4 | 0/5 | 0/2 |
| Event | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors |
|---|---|---|---|---|---|
| Food poisoningGastrointestinal disorders | 0/5 | 0/4 | 0/4 | 0/5 | 1/2 |
| NauseaGastrointestinal disorders | 0/5 | 0/4 | 0/4 | 0/5 | 1/2 |
| VomitingGastrointestinal disorders | 0/5 | 0/4 | 0/4 | 0/5 | 1/2 |
| Injection site reactionGeneral disorders | 1/5 | 0/4 | 0/4 | 0/5 | 1/2 |
| Oedema peripheralGeneral disorders | 0/5 | 0/4 | 0/4 | 0/5 | 1/2 |
| InfluenzaInfections and infestations | 0/5 | 0/4 | 0/4 | 0/5 | 1/2 |
| Limb injuryInjury, poisoning and procedural complications | 0/5 | 0/4 | 0/4 | 0/5 | 1/2 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/5 | 0/4 | 0/4 | 0/5 | 1/2 |
| Joint range of motion decreasedMusculoskeletal and connective tissue disorders | 0/5 | 0/4 | 0/4 | 0/5 | 1/2 |
| Joint swellingMusculoskeletal and connective tissue disorders | 0/5 | 0/4 | 0/4 | 0/5 | 1/2 |
Baseline analysis population included all participants who received at least 1 dose of study treatment.
| Age, Categorical(Participants) | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 4 | 5 | 2 | 20 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(Years) | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | Total |
|---|---|---|---|---|---|---|
| Mean | 33.0 ± 9.70 | 31.3 ± 10.63 | 41.8 ± 16.24 | 42.0 ± 5.24 | 20.0 ± 1.41 | 35.4 ± 11.63 |
| Sex: Female, Male(Participants) | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 5 | 4 | 4 | 5 | 2 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 1 | 1 | 0 | 7 |
| Not Hispanic or Latino | 2 | 2 | 3 | 4 | 2 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1: 300mg - 300mg Non-Inhibitor | Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor | Cohort 4: 300mg - 300mg Inhibitor | Cohort 5: De Novo 300mg Loading + 150mg Inhibitors | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 0 | 2 | 0 | 6 |
| White | 3 | 2 | 4 | 3 | 2 | 14 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
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Studies of the drug tested here: Marstacimab