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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01687608
The ClinicalTrials.gov registry entry for NCT01687608 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 95-participant average among 20 other Hemophilia B trials with a reported enrollment target (68% lower). The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
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 reports 15 study locations spanning 12 distinct geographic areas - top geographies include 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
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-
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.