stop_circleTerminated/Withdrawn
Hemophilia A
Bayer Identifier:
12112
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Assessment of the risk of inhibitor formation in previously treated patients with severe hemophilia A
Trial purpose
Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster Kidney cell line.
Key Participants Requirements
Sex
MaleAge
12 - 60 YearsTrial summary
Enrollment Goal
1Trial Dates
May 2006 - November 2006Phase
Phase 4Could I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hemophilia Treatment Center of Las Vegas | Las Vegas, 89109, United States |
Terminated | Henry Ford Health System | Detroit, 48202, United States |
Primary Outcome
- To evaluate whether a switch of replacement therapy from an rFVIII produced in a CHO cell line to an rFVIII produced in a BHK cell line is associated with a risk of inhibitor formation.date_rangeTime Frame:6 monthsenhanced_encryptionyesSafety Issue:
Secondary Outcome
- To quantify the risk of inhibitor formation, to assess the efficacy of the rFVIII-FS while on regular replacement therapy and to assess the quality-of-life (QoL) before and after the study.date_rangeTime Frame:6 monthsenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Supportive CareAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1