CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 246 enrolled
Drug / intervention
rVIII-SingleChainbiological
Likely dose
Not stated in 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/NCT02172950
NCT02172950Phase 3Completed
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A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A

CSL Behring·interventional·Posted Jun 24, 2014·Updated Oct 27, 2021

In Brief

A Phase 3 clinical trial evaluating rVIII-SingleChain for Hemophilia A and Severe Hemophilia A. Completed, enrolled 246 participants across 64 sites in 25 countries.

Detailed Summary

This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A, Severe Hemophilia A
CountriesAustralia, Austria, Canada, Czechia, France, Georgia, Germany, Hungary, Ireland, Italy, Japan, Lebanon, Malaysia, Netherlands, Philippines, Poland, Portugal, Romania, South Africa, Spain, Switzerland, Thailand, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 24, 2014
Enrollment StartOct 13, 2014
Primary CompletionJan 19, 2021
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 12.0 years ago

Interventions

rVIII-SingleChainbiological

Recombinant single-chain coagulation factor VIII