EUCTR2012-003463-22-FR
Active, not recruiting
Phase 1
A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV
ConditionsChronic Hepatitis C Virus Infection (Genotype 1, 2, 3, 4)MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsRIBASPHERE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C Virus Infection (Genotype 1, 2, 3, 4)
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 71
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infection with the hepatitis C virus (HCV) with underlying mild or moderate hemophilia
- •Males 18 years of age and above
- •Have not been previously treated with an interferon
- •Are the trial subjects under 18? no
- •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 117
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 13
Exclusion Criteria
- •Not infected with the hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
- •Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease
- •Presence of Bethesda inhibitor
Outcomes
Primary Outcomes
Not specified
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