Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2011-001785-17-GB
EUCTR2011-001785-17-GB
Active, not recruiting
Phase 1

Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII - GENA-13

Octapharma AG0 sites49 target enrollmentAugust 8, 2011
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSevere Haemophilia AMedDRA version: 17.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Severe Haemophilia A
Sponsor
Octapharma AG
Enrollment
49
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 8, 2011
End Date
May 13, 2016
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Follow-Up study in Previously Treated Children to investigate a new FVIII concentrate
EUCTR2011-001785-17-PLOctapharma AG50
Active, not recruiting
Phase 1
Follow-Up study in Previously Treated Children to investigate a new FVIII concentrateSevere Haemophilia AMedDRA version: 14.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2011-001785-17-CZOctapharma AG60
Active, not recruiting
Phase 1
Follow-Up study in Previously Treated Children to investigate a new FVIII concentrateSevere Haemophilia AMedDRA version: 14.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2011-001785-17-FROctapharma AG60
Active, not recruiting
Not Applicable
Follow-Up study in Previously Treated Children to investigate a new FVIII concentrate
EUCTR2011-001785-17-ROOctapharma AG50
Completed
Not Applicable
The evaluation of effectiveness of Cydonia oblonga syrup on clinical symptoms in patients with Gastroesophageal reflux diseasePediatric gastro-oesophageal reflux disease.Gastro-oesophageal reflux disease without oesophagitis
IRCT2015030921388N1Shiraz University of Medical Sciences80