An observational study in Hemophilia A, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-09-27.
Sponsored by Bayer · Observational
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Among 57 studies in Hemophilia A by Bayer — 3 open to participants now, 6 under way, none of them phase 3. Hemophilia A · Bayer.
Among the 57 studies in Hemophilia A by Bayer, this one is the 8th largest by enrollment of the 26 observational ones that give a count, is one of 5 that started in 2018, is one of 26 observational ones, and was the 39th registered.
844 studies on the registry are indexed under Hemophilia A; 136 are open to participants now.
Browse Hemophilia A studies →3 of the 57 studies in Hemophilia A by Bayer are open now, in 12 countries. Recruiting first, the newest first:
Bayer · Sites in United States, Brazil, Canada and 8 more countries
Ages 7–12
Bayer · Sites in Korea, Republic of
Ages 12+
Bayer
Ages 18+
By country, each count listing its studies:
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: 12 Years and older · 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.
57 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 11 · Phase 2 5 · Phase 3 9 · Phase 4 8
First in 2002; this study’s year is marked. 5 started in 2018.
This study's enrollment of 160 is above the median of 81 across 310 observational studies indexed under Hemophilia A.
Median enrollment 27 across the 31 interventional studies, 67 across the 26 observational. Of the 50 that completed or were terminated, 14 (28%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
3 of the studies in Hemophilia A by Bayer that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03932201BayerEvaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A | 2026-12-31 |
| NCT05643560BayerAn Observational Study Called JOIHA to Learn More About How Well the Treatment With Jivi Works to Prevent Problems With Joints in Adults With Hemophilia A. | 2027-03-31 |
| NCT04461639BayerStudy to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding | 2027-03-31 |
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Among the 57 studies in Hemophilia A by Bayer, from their registry updates:
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This US study will assess hemophilia A patient characteristics, health history and reasons for switching or not switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A: 1) patients who have switched from conventional therapy to new FVIII products with an improved PK profile. 2) patients who remain on conventional therapy (who have never switched) but have considered switching, including those patients who switched from conventional therapy to new FVIII products with improved pharmacokinetics and then subsequently "switched back" to conventional replacement therapy. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.
Study Population for the Patient/Caregiver Study:
Hemophilia A patients/caregivers will be recruited via opt-in patient panels and/or research databases.
Patients with hemophilia A (≥ 18 years of age) or caregivers of children with hemophilia A (≥12-\<18 years of age)
Study Population for the Physician Chart Study:
The study population for the physician chart review study will be patients, who initiated FVIII products with improved half-life for the treatment of hemophilia A during the eligibility period. In order to obtain a broad patient population that is representative of real world prescribing; all eligible patients will be included in the study irrespective of the FVIII product with improved half-life received.
Inclusion Criteria:
Inclusion criteria for patients/caregivers in the Patient/Caregiver Study:
Inclusion criteria for physicians:
Inclusion criteria for patients in the physician chart study:
Exclusion Criteria:
Exclusion criteria for patients/caregivers in the Patient/Caregiver Study:
Exclusion criteria for physicians:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Qualitative patient/caregiver study: Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life
Drug: FVIII products · Drug: Conventional FVIII replacement therapies
Qualitative patient/caregiver study: Hemophilia A patients/caregivers (N=30) receiving "conventional" FVIII replacement therapy for at least 6 months who are considering switching to a FVIII product with improved half-life within the next 1 year
Drug: Conventional FVIII replacement therapies
Quantitative physician interview/ chart review study: Hemophilia A patients (N=100) who have switched from "conventional" FVIII replacement therapy to FVIII products with improved half-life.
Drug: FVIII products · Drug: Conventional FVIII replacement therapies
Adynovate, Eloctate, Afstyla, Kovaltry
Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha
The reasons of patients/caregivers "switch" from conventional FVIII replacement therapy to FVIII products with improved half-life
These patients/caregivers will participate in an asynchronous online discussion forum consisting of predetermined open ended and close ended questions for a series of 6 consecutive days completing approximately 20 minutes' worth of questions per day.
Time frame: Up to 6 days
The obstacles of switching among hemophilia A patients who did not switch from conventional therapy to FVIII products with improved half-life but who are open to switching
These patients/caregivers will participate in an asynchronous online discussion forum consisting of predetermined open ended and close ended questions for a series of 6 consecutive days completing approximately 20 minutes' worth of questions per day.
Time frame: Up to 6 days
The clinical characteristics of patients who switch from conventional FVIII replacement therapy to FVIII products with improved half-life
A retrospective patient medical chart review
Time frame: Up to 4.5 months
The changes of treatment characteristics from 6 months prior to switching compared to 6 months after switching from conventional FVIII replacement therapy to FVIII products with improved half-life
A retrospective patient medical chart review
Time frame: Up to 4.5 months
The changes of bleeding related outcomes from 6 months prior to switching compared to 6 months after switching from conventional FVIII replacement therapy to FVIII products with improved half-life
A retrospective patient medical chart review
Time frame: Up to 4.5 months
The reasons for switching from conventional FVIII replacement therapy to FVIII products with improved half-life, from the physician perspective
A retrospective patient medical chart review
Time frame: Up to 4.5 months
Ran from Feb 2018 to primary completion in Jun 2018, 3 months.
Of 53 industry-sponsored observational studies under Hemophilia A, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 79. This study's 3 months is below that.
Counting every sponsor, half of 131 studies reached it within 45 months; a quarter within 25 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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