Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A
Public ClinicalTrials.gov record NCT01775618. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Phase III, Non-controlled, Open-label Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of BAY94-9027 for Prophylaxis and Treatment of Bleeding in Previously Treated Children (Age <12 Years) With Severe Hemophilia A
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. Hemophilia A causes the clotting process to be slowed and the person experiences bleeds causing serious problems that could lead to disability. The current standard treatment for severe hemophilia A is infusion of FVIII to stop bleeding, or regular scheduled treatment to prevent bleeds from occuring. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day. In this trial safety and efficacy of a long-acting recombinant Factor VIII molecule is being evaluated in 50 male subjects, \< 12 years of age, with severe Hemophilia A. These subjects will receive open label treatment with long-acting rFVIII for approximately 6 months (or longer until 50 exposure days) on a regular schedule at least once every 7-days. Doses and dose intervals may be adapted to the subject's clinical need. A second group of patients will receive open label treatment with the same drug for 12 weeks on a regular schedule of 2x/week. Patients will attend the treatment center for routine blood samples and will be required to keep an electronic diary. Subjects will be offered participation in an optional extension study to collect observations for at least an additional 50 exposure days.
Study identification
- NCT ID
- NCT01775618
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 73 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 12 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 28, 2013
- Primary completion
- Mar 18, 2015
- Completion
- Feb 18, 2020
- Last update posted
- Aug 20, 2020
2013 – 2020
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Sacramento | California | 95817 | — |
| Not listed | Pensacola | Florida | 32504 | — |
| Not listed | Cincinnati | Ohio | 45229 | — |
| Not listed | Cleveland | Ohio | 44106-6007 | — |
| Not listed | Columbus | Ohio | 43205-2696 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Salt Lake City | Utah | 84113 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
Recently updated Hemophilia A trials
Other public records listing Hemophilia A. Sorted by last update posted; newest first. Not a recommendation.
- NCT05611801: A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B Recruiting
- NCT07416526: A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A Recruiting
- NCT03818763: Gene Therapy Trial for Platelet Derived Factor VIII Production in Hemophilia A Active, not recruiting
- NCT07692217: TG-INSIGHT With Joint POCUS, Hemostatic Potential in Patients With Severe Hemophilia A on Novel Replacement and Substitution FVIII Therapies Not yet recruiting
- NCT05022459: Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis Recruiting
- NCT03655223: Early Check: Expanded Screening in Newborns Active, not recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01775618, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2020 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01775618 live on ClinicalTrials.gov.