EUCTR2016-003681-34-BG
Active, not recruiting
Phase 1
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Patients with Severe Hemophilia A
ConditionsSevere hemophilia A (<1% FVIII:C)MedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsWilate
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Severe hemophilia A (<1% FVIII:C)
- Sponsor
- Octapharma AG
- Enrollment
- 55
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Severe hemophilia A (\<1% FVIII:C) according to medical history
- •2\. Male patients aged \=12 years
- •3\. Previous treatment with a FVIII concentrate for at least 150 exposure days (EDs)
- •4\. Immunocompetence (CD4\+ count \>200/µL)
- •5\. Good documentation of the historical bleeding rate (at least for the 6 months pre\-ceding study start)
- •6\. Voluntarily given, fully informed written and signed consent obtained by the pa\-tient (or parent/legal guardian in case of adolescents) before any study\-related pro\-cedures are conducted
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 40
Exclusion Criteria
- •1\. Any coagulation disorders other than hemophilia A
- •2\. History of FVIII inhibitor activity (\=0\.6 BU) or detectable FVIII inhibitory anti\-bodies (\=0\.6 BU using the Nijmegen modification of the Bethesda assay) at screening, as determined by the central laboratory
- •3\. Severe liver or kidney diseases (alanine aminotransferase \[ALAT] and aspartate transaminase \[ASAT] levels \>5 times of upper limit of normal, creatinine
- •\>120 µmol/L)
- •4\. Patients receiving or scheduled to receive immunomodulating drugs (other than anti\-retroviral chemotherapy) such as alpha\-interferon, prednisone (equivalent to \>10 mg/day), or similar drugs
- •5\. Treatment with any investigational medicinal product in another interventional clinical study currently or within 4 weeks before enrollment
Outcomes
Primary Outcomes
Not specified
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