EUCTR2011-005409-65-GB
Active, not recruiting
Phase 1
A Phase 3 Evaluation of Daclatasvir in Combination with Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination with Peginterferon Alfa-2a and RBV in Patients with Chronic Hepatitis C Genotype 1b who are Treatment Naïve or Prior Relapsers to Alfa/RBV Therapy (The STRUCTURE Study) Revised Protocol 03, incorporating Amendment 09 (version 1.0, dated 09-Jul-2013) + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 21-Jun-12) - The STRUCTURE Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C Virus Infection (Genotype 1b)
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 641
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients chronically infected with HCV GT\-1b
- •Naïve to prior treatment or documented evidence of relapse after 48 wks of treatment with alfa/RBV
- •HCV RNA viral load \= 100,000 IU/mL at screening
- •Patients with compensated cirrhosis are permitted
- •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 527
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 58
Exclusion Criteria
- •Infection with HCV other than GT\-1b
- •Positive HBsAg or HIV\-1/HIV\-2 antibody test at screening
- •Evidence of chronic liver disease caused by diseases other than chronic HCV infection
- •Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
- •Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
- •Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
- •Laboratory values: hemoglobin \< 12\.0 g/dL (males) or \< 11\.0 g/dL (females), platelets \<90,000/mm³, total serum bilirubin \= 2 mg/dL (unless due to Gilbert’s disease)
Outcomes
Primary Outcomes
Not specified
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