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An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A

NCT02172950 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2021-10-27

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

rVIII-SingleChain

Recombinant single-chain coagulation factor VIII

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Program Director · CSL Behring

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-13
Primary Completion
2021-01-19
Completion
2021-01-19

Countries

  • United States
  • Australia
  • 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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02172950 on ClinicalTrials.gov