Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
Public ClinicalTrials.gov record NCT01439971. 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
An Ascending Single Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics/Pharmacodynamics Of Pf-05280602, A Recombinant Factor Viia Variant (813d), In Adult Hemophilia A And B Subjects With Or Without Inhibitors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in hemophilic animal models.
Study identification
- NCT ID
- NCT01439971
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 29 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 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
- Nov 30, 2011
- Primary completion
- Sep 30, 2015
- Completion
- Sep 30, 2015
- Last update posted
- May 11, 2017
2011 – 2015
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego Medical Center | San Diego | California | 92103-8651 | — |
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Doernbecher Children's Hospital | Portland | Oregon | 97239 | — |
| OHSU Investigational Pharmacy | Portland | Oregon | 97239 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| CTRC | Philadelphia | Pennsylvania | 19104 | — |
| Penn Comprehensive Hemophilia Program - Center for Blood Disorders | Philadelphia | Pennsylvania | 19104 | — |
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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01439971, 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 May 11, 2017 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01439971 live on ClinicalTrials.gov.