The ability to induce an immune response, efficacy and safety of treatment with Human-cl rhFVIII in previously Untreated Patients ,affected by inherited gender-related coagulation disorder ,in which affected males do not produce functional coagulation factor VIII (FVIII) in sufficient quantities to achieve satisfactory blood clotting.

Phase 1

• Conditions: Severe Haemophilia A; MedDRA version: 16.1 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-002554-23-FR
• Lead Sponsor: OCTAPHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-02
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

In order to qualify for study enrolment, the following criteria must be fulfilled before study entry:
1. Male patients
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 given before any study related procedures are conducted (obtained from the patient’s parent(s)/legal guardian(s))
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients will not be included if any of the following exclusion criteria are met:
1. Diagnosis of a coagulation disorder other than haemophilia A
2. Severe liver or kidney disease (ALT or AST levels >5 times of upper limit of normal (ULN), 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified