Immunogenicity, efficacy and safety of treatment with Human-cl rhFVIII in previously untreated patients with severe haemophilia A: a prospective, multinational, open-label, non-controlled study

Octapharma AG (Switzerland)0 个研究点目标入组 100 人开始时间: 2013年10月22日最近更新: 2022年6月6日

试验速览

2018 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/28815880 interim results (added 14/05/2019)

•1. Male, no age limitations, but due to the required patient population it can be expected that the majority of patients going to be included are babies and small children.
•2. Severe haemophilia A (FVIII:C < 1%)
•3. No previous treatment with FVIII concentrates or other blood products containing FVIII
•4. Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted (obtained from the patient?s parent/legal guardian)

•1. Diagnosis with a coagulation disorder other than haemophilia A
•2. Severe liver or kidney disease (alanine amino transferase (ALT) or aspartate transaminase (AST) levels >5 times of upper limit of normal, creatinine >120 µmol/L)
•3. Concomitant treatment with any systemic immunosuppressive drug
•4. Participation in another interventional clinical study currently or during the past 4 weeks.

发起方

Octapharma AG (Switzerland)