Clinical trial NCT01797848: Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
Official title: A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects


Eligibility criteria: Inclusion Criteria:

* Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
* HCV RNA viral load ≥ 10,000 IU/mL
* Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
* Patients with compensated cirrhosis are permitted

Exclusion Criteria:

* Infected with HCV other than GT 1 or 4
* Evidence of decompensated liver disease
* Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy
* Evidence of a medical condition contributing to chronic liver disease other than HCV
* History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
* Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
* Laboratory values:

  1. Hemoglobin \< 12 g/dL (females) or \< 13 g/dL (males)
  2. Platelets \< 90 x 1000000000 cells/L
  3. Absolute neutrophil count (ANC) \< 1.5 × 1000000000 cells/L
  4. Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)

Primary outcomes:
measure: Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort
timeFrame: Week 24 post treatment follow up
Secondary outcomes:
measure: Proportion of Genotype (GT) 4 subjects with SVR24
timeFrame: Week 24 post treatment follow up visit
measure: Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable
timeFrame: Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12)
measure: Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)
timeFrame: Up to 48 weeks plus 30 days
measure: Discontinuations due to Adverse Events (AEs)
timeFrame: Up to 48 weeks plus 7 days
measure: Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene
timeFrame: Up to 72 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: