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

August 9, 2017 updated by: Octapharma

Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Hemophilia A

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Medizinische Universitaet Wien
  • Bulgaria
      • Sofia, Bulgaria, 1233
        • Haematological Hospital Joan Pavel
  • Germany
      • Bonn, Germany
        • Universitaetsklinikum
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany, 69123
        • SRH Kurpfalzkrankenhaus Heidelberg
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • Werlhof Institut fuer Haemostaseologie GmbH
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Basingstoke & North Hampshire NHS Foundation Trust
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • London, United Kingdom
        • Royal Free Hospital
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
      • Sheffield, United Kingdom
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Severe hemophilia A ((FVIII:C <= 1%)
  • Male subjects >= 12 years of age
  • Previously treated with FVIII concentrate, at least 50 EDs
  • Immunocompetent (CD4+ count > 200/ul)
  • Negative for anti- HIV; if positive, viral load < 200 particles/u; or <400,000 copies/mL

Exclusion Criteria:

  • Other coagulation disorder than hemophilia A
  • Present of past FVIII inhibitor activity (.= 0.6 BU)
  • Severe liver and kidney disease
  • Receiving of scheduled to receive immuno-modulating drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: human cl-rhFVIII
Biological: recombinant Factor VIII
intravenous infusion of factor FVIII every other day.
Other Names:
  • human-cl rhFVIII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months
Time Frame: At least 50 Exposure Days and at least 6 months
Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.
At least 50 Exposure Days and at least 6 months
Efficacy of Treating Bleeding Episodes
Time Frame: After each bleeding episode, up to 6 month

At the end of a bleeding episode, efficacy was assessed as:

  • Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion
  • Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an infusion requiring up to 2 infusions for complete resolution
  • Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution
  • None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution Efficacy was rated
After each bleeding episode, up to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Octapharma

Investigators

  • Principal Investigator: Johannes Oldenburg, Prof., Universitaetsklinikum Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (ESTIMATE)

May 18, 2010

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GENA-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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