Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

NCT01992549 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-01-19

Study results available
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Summary

The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.

Conditions

  • Severe Hemophilia A

Interventions

BIOLOGICAL

Human-cl rhFVIII

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Sigurd Knaub, PhD · Octapharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-12-27
Completion
2018-12-27

Countries

  • United States
  • Canada
  • France
  • Georgia
  • India
  • Moldova
  • Poland
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT01992549 on ClinicalTrials.gov