- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01125813
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
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Wien, Austria, 1090
- Medizinische Universitaet Wien
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Sofia, Bulgaria, 1233
- Haematological Hospital Joan Pavel
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Bonn, Germany
- Universitaetsklinikum
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Hamburg, Germany, 20246
- Universitaetsklinikum Hamburg-Eppendorf
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Heidelberg, Germany, 69123
- SRH Kurpfalzkrankenhaus Heidelberg
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Niedersachsen
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Hannover, Niedersachsen, Germany, 30159
- Werlhof Institut fuer Haemostaseologie GmbH
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Basingstoke, United Kingdom, RG24 9NA
- Basingstoke & North Hampshire NHS Foundation Trust
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Cardiff, United Kingdom
- University Hospital of Wales
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London, United Kingdom
- Royal Free Hospital
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Manchester, United Kingdom
- Manchester Royal Infirmary
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Sheffield, United Kingdom
- Royal Hallamshire Hospital
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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 |
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EXPERIMENTAL: human cl-rhFVIII
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intravenous infusion of factor FVIII every other day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.
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At least 50 Exposure Days and at least 6 months
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Efficacy of Treating Bleeding Episodes
Time Frame: After each bleeding episode, up to 6 month
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At the end of a bleeding episode, efficacy was assessed as:
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After each bleeding episode, up to 6 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Unknown
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BayerCompletedHemophilia AUnited States, Japan, United Kingdom, Spain
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Baxalta now part of ShireCompleted
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Sinocelltech Ltd.Unknown
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Unknown
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Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia AJapan