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Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A

NCT01125813 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-09-11

Study results available
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Summary

This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.

Conditions

  • Severe Hemophilia A

Interventions

BIOLOGICAL

recombinant Factor VIII

intravenous infusion of factor FVIII every other day.

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Johannes Oldenburg, Prof. · Universitaetsklinikum Bonn

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Austria
  • Bulgaria
  • Germany
  • 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 NCT01125813 on ClinicalTrials.gov