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: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-24
• Study Start: 2021-01-21
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 108

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:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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