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NCT03061201 · ClinicalTrials.gov registry record · Phase 2
A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03061201: Completed Phase 2 study, sponsored by Pfizer.
NCT03061201 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03061201, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety, tolerability and time-course profile of FVIII activity after dosing with SB-525 (PF-07055480)
Primary Outcome
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more
Interventions
- BIOLOGICAL SB-525 (PF-07055480)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-06-21 |
| Est. Completion | 2024-07-16 |
| Phase | Phase 2 |
What the finished NCT03061201 record still lists
NCT03061201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which SB-525 (PF-07055480) is the first listed.
NCT03061201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03061201 about?
NCT03061201 is a clinical study titled "A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A". The purpose of the study is to evaluate the safety, tolerability and time-course profile of FVIII activity after dosing with SB-525 (PF-07055480)
What is the current status of trial NCT03061201?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2017-06-21. Estimated completion is 2024-07-16.
What interventions are being tested in trial NCT03061201?
The interventions under investigation include: SB-525 (PF-07055480) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03061201?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03061201's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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