Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)
This study has been completed.
Sponsor:
Octapharma
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01341912
First received: April 22, 2011
Last updated: October 2, 2012
Last verified: October 2012
| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 22, 2011 |
| Last Updated Date | October 2, 2012 |
| Start Date ICMJE | June 2011 |
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Long-term immunogenicity [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ] Patients will be monitored for inhibitors against FVIII every 3 months. |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01341912 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
To determine long-term efficacy of Human-cl rhFVIII in the treatment of bleeding episodes and in surgical prophylaxis [ Time Frame: up to 3 years ] [ Designated as safety issue: No ] The efficacy of human-cl rhFVIII will be determined using a 4 point efficacy assessment scale. |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs) |
| Official Title ICMJE | Clinical Study to Investigate the Long-Term Efficacy, Safety and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A - Extension Study to GENA-01 |
| Brief Summary | The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 3 |
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Severe Hemophilia A |
| Intervention ICMJE | Biological: Human-cl rhFVIII
Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery. |
| Study Arm (s) | Experimental: Human-cl rhFVIII
Recombinant FVIII derived from a human cell line.
Intervention: Biological: Human-cl rhFVIII |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 3 |
| Completion Date | August 2012 |
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Male |
| Ages | 12 Years to 65 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Bulgaria |
| Administrative Information | |
| NCT Number ICMJE | NCT01341912 |
| Other Study ID Numbers ICMJE | GENA-11 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Octapharma |
| Study Sponsor ICMJE | Octapharma |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Octapharma |
| Verification Date | October 2012 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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