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NCT01625390 · ClinicalTrials.gov registry record · Phase 2
A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01625390: Completed Phase 2 study, sponsored by Bayer.
NCT01625390 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625390, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability. The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process. The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months. Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study. Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.
Primary Outcome
A bleed was defined as successfully treated, if no administration of rescue medication was required.
Interventions
- DRUG BAY86-6150
- DRUG eptacog alfa [activated]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
What the finished NCT01625390 record still lists
NCT01625390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which BAY86-6150 is the first listed.
NCT01625390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01625390 about?
NCT01625390 is a clinical study titled "A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150". Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episode...
What is the current status of trial NCT01625390?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2012-06. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01625390?
The interventions under investigation include: BAY86-6150 (DRUG), eptacog alfa [activated] (DRUG).
Who is sponsoring clinical trial NCT01625390?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01625390's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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