Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2010-023242-69-DE
EUCTR2010-023242-69-DE
Active, not recruiting
Not Applicable

Clinical Study to Investigate the Long-Term Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients with Severe Haemophilia A – Extension Study to GENA-01

Octapharma AG0 sites25 target enrollmentFebruary 8, 2011
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSevere haemophilia A (FVIII:C <1%)MedDRA version: 12.1Level: LLTClassification code 10018937Term: Haemophilia A

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe haemophilia A (FVIII:C <1%)
Sponsor
Octapharma AG
Enrollment
25
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 8, 2011
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Completion of GENA\-01 study with at least 50 Exposure Days (EDs) and at least 6 months study participation and immediate enrolment into GENA\-11\.
  • •Voluntarily given, fully informed written and signed consent obtained before any study\-related procedures are conducted.
  • •Patient must be capable to understand and comply with the relevant aspects of the study protocol.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •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

  • •Development of FVIII inhibitors (\=0\.6 BU), during the course of the GENA\-01 study.
  • •Development of any severe liver or kidney disease (ALT and AST levels \>5 times of upper limit of normal, creatinine \>120 µmol/L) during the course of the GENA\-01 study.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Unknown
Phase 3
A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use
JPRN-jRCT2080220543AstraZeneca
Withdrawn
Not Applicable
A Study to Evaluate the Use of GALA (Trademark), a Preservation Solution for Blood Vessels in Patients Undergoing Coronary Artery Bypass Graft Surgery.
ACTRN12613000707763Mobius Medical Pty Ltd25
Recruiting
Not Applicable
A prospective study to evaluate the long-term effectiveness, safety, and performance of the Saluda Medical’s EvokeTM Closed-Loop Spinal Cord Stimulation System incorporating feedback control to treat patients with chronic pain of the trunk and/or limbs
NL-OMON27839Saluda Medical70
Completed
Not Applicable
Clinical study to investigate the long-term safety and efficacy of human cell line recombinant Factor VIII (human-cl rhFVIII) in previously treated patients with severe haemophilia ASevere haemophilia AHaematological DisordersHereditary factor VIII deficiency
ISRCTN90038418Octapharma AG (Switzerland)22
Active, not recruiting
Not Applicable
Estudio de la eficacia del tratamiento a largo plazo con suero salino hipertónico sobre las exacerbaciones pulmonares en pacientes con Fibrosis Quística
EUCTR2008-001284-11-ESADELAIDA LAMAS FERREIRO