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

Primary Purpose

Severe Hemophilia A

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
recombinant Factor VIII
Sponsored by
Octapharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Hemophilia A

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Universitaet Wien
  • Haematological Hospital Joan Pavel
  • Werlhof Institut fuer Haemostaseologie GmbH
  • Universitaetsklinikum
  • Universitaetsklinikum Hamburg-Eppendorf
  • SRH Kurpfalzkrankenhaus Heidelberg
  • Basingstoke & North Hampshire NHS Foundation Trust
  • University Hospital of Wales
  • Royal Free Hospital
  • Manchester Royal Infirmary
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

human cl-rhFVIII

Arm Description

Outcomes

Primary Outcome Measures

Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months
Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.
Efficacy of Treating Bleeding Episodes
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

Secondary Outcome Measures

Full Information

First Posted
May 17, 2010
Last Updated
August 9, 2017
Sponsor
Octapharma
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1. Study Identification

Unique Protocol Identification Number
NCT01125813
Brief Title
Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A
Official Title
Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Hemophilia A
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Octapharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hemophilia A

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
human cl-rhFVIII
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
recombinant Factor VIII
Other Intervention Name(s)
human-cl rhFVIII
Intervention Description
intravenous infusion of factor FVIII every other day.
Primary Outcome Measure Information:
Title
Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months
Description
Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.
Time Frame
At least 50 Exposure Days and at least 6 months
Title
Efficacy of Treating Bleeding Episodes
Description
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
Time Frame
After each bleeding episode, up to 6 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Oldenburg, Prof.
Organizational Affiliation
Universitaetsklinikum Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universitaet Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Haematological Hospital Joan Pavel
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Werlhof Institut fuer Haemostaseologie GmbH
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30159
Country
Germany
Facility Name
Universitaetsklinikum
City
Bonn
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
SRH Kurpfalzkrankenhaus Heidelberg
City
Heidelberg
ZIP/Postal Code
69123
Country
Germany
Facility Name
Basingstoke & North Hampshire NHS Foundation Trust
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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