Chronic Hepatitis C MedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Daclatasvir
Product Code: BMS-790052
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Daclatasvir
Current Sponsor code: BMS-790052
Other descriptive name: DCV
Concentration u
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion 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 F.1.2.1 Number of subjects for this age range 234 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
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); • Any criteria that would exclude the subject from receiving RBV. Exclusion Laboratory results: • Confirmed ANC 500 mSec • CrCl= 50 mL/min • AFP > 100 ng/mL OR • AFP = 50 ng/mL and = 100 ng/mL requires a liver ultrasound (HCC are excluded) • Albumin < 3.5 g/dL (35 g/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of daclatasvir and TMC435 with and without ribavirin, as determined by the proportion of subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12.;Secondary Objective: • To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs; • To assess the relationship between efficacy and the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene; • To assess the efficacy as determined by: - HCV RNA < LOQ at each of the following time points: Weeks 1, 2, 4, 6, 8 (and 12), EOT, post-treatment Week 24 (SVR24), and post-treatment Week 36 (genotype 1b for 12 week arms); - HCV RNA undetectable at each of the following time points: Weeks 1, 2, 4, 6, 8 (and 12), EOT, post-treatment Week 12, post treatment Week 24, and post-treatment Week 36 (genotype 1b for 12 week arms).;Primary end point(s): Antiviral activity, as determined by the proportion of subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for each cohort defined by the previous response status (Naive, Null), HCV genotype, initial treatment regimen and treatment duration. ;Timepoint(s) of evaluation of this end point: 12 weeks post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • On-treatment safety, as measured by the frequency of SAEs and discontinuations due to AEs from start (Day 1) to end of treatment (up to 24 weeks) plus 7 days. • Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each treatment arm. • Proportion of subjects with HCV RNA < LOQ at each of the following time points: Weeks 1, 2, 4, 6, and 8 (and 12); EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each treatment arm, and post-treatment Week 36 (genotype 1b) for subjects in the 12 week treatment arms; • Proportion of subjects with HCV RNA undetectable at each of the following time points: Weeks 1, 2, 4, 6, and 8 (and 12); EOT (up to 24 weeks), post-treatment Week 12 and post-treatment Week 24 for each treatment arm, and post-treatment Week 36 (genotype 1b) for subjects in the 12 week treatment arms. ;Timepoint(s) of evaluation of this end point: • from start (Day 1) to end of treatment (up to 24 weeks) plus 7 days. • post treatment week 12 • at each of the following time points: Weeks 1, 2, 4, 6, and 8 (and 12); EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each treatment arm, and post-treatment Week 36 (genotype 1b) for subjects in the 12 week treatment arms; • at each of the following time points: Weeks 1, 2, 4, 6, and 8 (and 12); EOT (up to 24 weeks), post-treatment Week 12 and post-treatment Week 24 for each treatment arm, and post-treatment Week 36 (genotype 1b) for subjects in the 12 week treatment arms. | — |
Countries
Argentina, Chile, France, Germany, Hungary, Russian Federation, Spain, United States
Contacts
Public ContactEU Study Start-Up Unit
Bristol-Myers Squibb International Corporation
Outcome results
None listed