Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01573351
First received: April 5, 2012
Last updated: September 19, 2014
Last verified: September 2014

April 5, 2012
September 19, 2014
May 2012
September 2013   (final data collection date for primary outcome measure)
Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1 [ Time Frame: At 12 weeks post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01573351 on ClinicalTrials.gov Archive Site
  • On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment [ Time Frame: Through the end of treatment (maximum up to 24 weeks) plus 7 days ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene [ Time Frame: At post-treatment Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with HCV RNA undetectable [ Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects with HCV RNA < LOQ [ Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24) ] [ Designated as safety issue: No ]
  • Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.

  • ASV = Asunaprevir (BMS-650032)
  • DCV = Daclatasvir (BMS-790052)
  • Peg = Peg-interferon Alfa-2a (PegIFN)
  • Rib = Ribavirin (RBV)
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C Virus
  • Drug: Asunaprevir
    Other Name: BMS-650032
  • Drug: Daclatasvir
    Other Name: BMS-790052
  • Drug: Peg-interferon Alfa-2a
    Other Name: Pegasys®
  • Drug: Ribavirin
    Other Name: Copegus®
Experimental: QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Asunaprevir: Capsule, Oral, 100 mg, Twice daily, 24 weeks

Daclatasvir: Tablet, Oral, 60 mg, Once daily, 24 weeks

Peg-interferon Alfa-2a: Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks

Ribavirin: Tablet, Oral, 1000 mg/1200 mg (total daily dose), 24 weeks

Interventions:
  • Drug: Asunaprevir
  • Drug: Daclatasvir
  • Drug: Peg-interferon Alfa-2a
  • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
398
December 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females, ≥ 18 years of age
  • HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy
  • HCV RNA ≥ 10,000 IU/mL
  • Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
  • Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

Exclusion Criteria:

  • Prior treatment of HCV with HCV direct acting antiviral (DAA)
  • Evidence of a medical condition contributing to chronic liver disease other than HCV
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
  • Diagnosed or suspected hepatocellular carcinoma or other malignancies
  • Uncontrolled diabetes or hypertension
  • Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
  • Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
  • Albumin < 3.5 g/dL (35 g/L)
  • Alpha Fetoprotein (AFP) > 100 ng/mL (>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
  • Absolute neutrophil count (ANC) < 1.5 x 1000,000,000 cells/L (< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
  • Platelets < 90 x 1000,000,000 cells/L
  • Hemoglobin < 12 g/dL for females or < 13 g/dL for males
  • Any criteria that would exclude the subject from receiving P/R
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Russian Federation,   Taiwan,   Switzerland,   Sweden,   Spain,   Argentina,   Canada,   Denmark,   Germany,   Italy,   Korea, Republic of,   Mexico,   Netherlands
 
NCT01573351
AI447-029, 2011-005422-21
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP