Follow-Up study in Previously Treated Children to investigate a new FVIII concentrate

Phase 1

• Conditions: Severe Haemophilia A; MedDRA version: 17.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-001785-17-GB
• Lead Sponsor: Octapharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-08
• Study Completion: 2016-05-13
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 49

Inclusion Criteria

1.Evaluable completion of study GENA-03 by having a study participation period of 6 months, provided that prophylaxis with Human-cl rhFVIII is continued without intermediate interruption.
2.Voluntarily given, fully informed written and signed consent obtained from the parents (or legal guardians) before any study-related procedures are conducted. The need for obtaining assent will depend on the subjects’ developmental stage and intellectual capacity.
3.Capability to understand and comply with the relevant aspects of the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Development of FVIII inhibitors (=0.6 Bethesda units [BU]) in the course of study GENA-03.
2.Any severe liver or kidney disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >5 times of upper limit of normal, creatinine >120 µmol/L).

Study & Design

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