Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B
Public ClinicalTrials.gov record NCT00768287. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To evaluate the safety (acute effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis and with respect to control of hemorrhaging in both the prophylaxis and on demand groups of IB1001 in subjects with hemophilia B. Key Secondary Objectives: To evaluate the ability of IB1001 to provide coverage against bleeding under surgical circumstances; To evaluate the long-term safety and efficacy of IB1001
Study identification
- NCT ID
- NCT00768287
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 77 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years and older
- Sex
- All
- 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
- Jan 2009 (Actual)
- Primary completion
- Mar 2013 (Actual)
- Completion
- Dec 2016 (Actual)
- Last update posted
- Apr 6, 2021
2009 – 2016
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
| The Hemophilia Treatment Center of Orthopaedic Hospital | Los Angeles | California | 90007 | — |
| Emory University School of Medicine Pediatric Hematology | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center-Pediatric Hematology Oncology | Chicago | Illinois | 60612 | — |
| Indiana Hemophilia & Thrombosis Center | Indianapolis | Indiana | 46260 | — |
| University of Minnesota Center for Bleeding and Clotting Disorder | Minneapolis | Minnesota | 55455 | — |
| Hemophilia Treatment Center of Las Vegas | Las Vegas | Nevada | 89109 | — |
| Hemophilia and Thrombosis Center | Cincinnati | Ohio | 45229 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| University of Texas Health Science Center-Houston, Gulf States Hemophilia & Thrombophilia Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00768287, 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 Apr 6, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00768287 live on ClinicalTrials.gov.