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NCT01687608 · ClinicalTrials.gov registry record · Phase 1
Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B
A Phase 1 study of Hemophilia B, sponsored by Baxalta now part of Shire.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 15
- Study locations
NCT01687608: Active Phase 1 study of Hemophilia B, sponsored by Baxalta now part of Shire.
NCT01687608 is a Phase 1 study of Hemophilia B that is active but no longer recruiting, run by Baxalta now part of Shire. The registered enrollment target is 30 participants, below the 95-participant average among 20 other Hemophilia B trials with a reported enrollment target (68% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01687608, a Phase 1 study of Hemophilia B, is active but no longer recruiting, sponsored by Baxalta now part of Shire.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to evaluate the safety of single ascending IV doses of a Factor IX (FIX) Gene Therapy in up to 16 Adults with Hemophilia B.
Conditions Studied
Interventions
- BIOLOGICAL AskBio009
Study Locations (15)
California
- Orthopaedic Hemophilia Treatment Center - Los Angeles
- Children's Hospital Los Angeles - Los Angeles
- University of California Davis Medical Center - Sacramento
- University of California at San Diego Medical Center - San Diego
Colorado
- U of Colorado School of Medicine, Hemophilia & Thrombosis Treatment Center - Aurora
Georgia
- Emory University - Atlanta
Illinois
- Rush University Medical Center - Chicago
Massachusetts
- Children's Hospital of Boston - Boston
Minnesota
- University of Minnesota, Masonic Clinical Research Unit, Clinical and Translational Science Institute - Minneapolis
New York
- Mount Sinai Medical Center - New York
Oregon
- The Hemophilia Center, Oregon Health and Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-02-11 |
| Est. Completion | 2030-01-17 |
| Phase | Phase 1 |
What the registry record for NCT01687608 still lists
NCT01687608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 95-participant average among 20 other Hemophilia B trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Hemophilia B appearing as the primary indexed condition, and to 1 intervention - of which AskBio009 is the first listed.
NCT01687608 lists 15 locations in 12 states (California, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT01687608 about?
NCT01687608 is a clinical study titled "Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B". The purpose of this study is to evaluate the safety of single ascending IV doses of a Factor IX (FIX) Gene Therapy in up to 16 Adults with Hemophilia B.
What is the current status of trial NCT01687608?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-02-11. Estimated completion is 2030-01-17.
What conditions does trial NCT01687608 study?
This clinical trial studies the following conditions: Hemophilia B.
What interventions are being tested in trial NCT01687608?
The interventions under investigation include: AskBio009 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01687608?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01687608 being conducted?
This trial has 15 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01687608's enrollment target sits among peer trials
30 13th of 20 higher than 8 of 20 other Hemophilia B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia B 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
-
BeCoMe-9: A Clinical Study of BE-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B
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RECRUITING · Phase 1
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A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)
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-
A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B
RECRUITING · Phase 3
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