EUCTR2012-000070-28-HU
Active, not recruiting
Not Applicable
A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy with Genotype 1 Chronic Hepatitis C+Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, dated 14-May-12)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 260
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HCV Genotype 1a or 1b;
- •Males and females, \= 18 years of age;
- •HCV RNA \> 10,000 IU/mL;
- •Subjects with compensated cirrhosis are permitted.
- •Advanced fibrosis (F3/F4\) is capped at approximately 35% of the total treated population with a minimum of 20% F4 subjects.
- •If no cirrhosis, a liver biopsy within 3 years prior to enrollment is required
- •If cirrhosis is present, any prior liver biopsy is sufficient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Target Disease Exceptions
- •Liver or any other transplant (other than cornea and hair):
- •Evidence of a medical condition contributing to chronic liver disease other than HCV;
- •Current or known history of cancer, (except situ carcinoma or adequately tx basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
- •Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy;
- •Subjects infected with HIV or HBV;
- •Gastrointestinal disease impacting absorption of study drug;
- •Uncontrolled diabetes or hypertension;
- •Medication related
- •Prior treatment of HCV with HCV direct acting agent (DAA);
Outcomes
Primary Outcomes
Not specified
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