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Active, not recruiting Phase 1Phase 2 Interventional

Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B

ClinicalTrials.gov ID: NCT01687608

Public ClinicalTrials.gov record NCT01687608. 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.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 10:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2 Open-Label, Single Ascending Dose Trial of a Self-Complementing Optimized Adeno-associated Virus Serotype 8 Factor IX Gene Therapy (AskBio009) in Adults With Hemophilia B

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01687608
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
30 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 75 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
Feb 11, 2013 (Actual)
Primary completion
Jan 17, 2030 (Estimated)
Completion
Jan 17, 2030 (Estimated)
Last update posted
Mar 20, 2026

2013 – 2030

United States locations

U.S. sites
15
U.S. states
12
U.S. cities
14
Facility City State ZIP Site status
Orthopaedic Hemophilia Treatment Center Los Angeles California 90007 —
Children's Hospital Los Angeles Los Angeles California 90027 —
University of California Davis Medical Center Sacramento California 95817 —
University of California at San Diego Medical Center San Diego California 92103-8651 —
U of Colorado School of Medicine, Hemophilia & Thrombosis Treatment Center Aurora Colorado 80045 —
Emory University Atlanta Georgia 30322 —
Rush University Medical Center Chicago Illinois 60612 —
Children's Hospital of Boston Boston Massachusetts 022105 —
University of Minnesota, Masonic Clinical Research Unit, Clinical and Translational Science Institute Minneapolis Minnesota 55455 —
Mount Sinai Medical Center New York New York 10029 —
The Hemophilia Center, Oregon Health and Science University Portland Oregon 97239 —
Medical University of South Carolina Charleston South Carolina 29425 —
Gulf States Hemophilia and Thrombosis Center Houston Texas 77030 —
Bloodworks Northwest Seattle Washington 98104 —
BloodCenter of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01687608, 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 Mar 20, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01687608 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →