CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
PF-05280602 +4 morebiological
Likely dose
PF-05280602 0.5 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01439971
NCT01439971Phase 1Completed
CompareCT.gov

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

Catalyst Biosciences·interventional·Posted Sep 23, 2011·Updated May 12, 2017

In Brief

A Phase 1 clinical trial evaluating PF-05280602 for Hemophilia A. Completed, enrolled 29 participants across 23 sites in 8 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesBelgium, Hungary, Italy, New Zealand, South Africa, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2011
Enrollment StartDec 1, 2011
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.8 years ago

Interventions

PF-05280602biological

0.5 micrograms per kilogram of PF-05280602, IV infusion, single dose

PF-05280602biological

4.5 micrograms per kilogram of PF-05280602, IV infusion, single dose

PF-05280602biological

9.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

PF-05280602biological

18.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

PF-05280602biological

30.0 micrograms per kilogram of PF-05280602, IV infusion, single dose