Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials) (Hallmark QUAD)
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ClinicalTrials.gov Identifier: NCT01573351 |
Recruitment Status
:
Completed
First Posted
: April 9, 2012
Last Update Posted
: October 9, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C Virus | Drug: Asunaprevir Drug: Daclatasvir Drug: Peg-interferon Alfa-2a Drug: Ribavirin | Phase 3 |
- ASV = Asunaprevir (BMS-650032)
- DCV = Daclatasvir (BMS-790052)
- Peg = Peg-interferon Alfa-2a (PegIFN)
- Rib = Ribavirin (RBV)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 398 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | December 2013 |
Arm | Intervention/treatment |
---|---|
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 |
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®
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- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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) ]
- Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects [ Time Frame: Post-treatment Week 12 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573351

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT01573351 History of Changes |
Other Study ID Numbers: |
AI447-029 2011-005422-21 ( EudraCT Number ) |
First Posted: | April 9, 2012 Key Record Dates |
Last Update Posted: | October 9, 2015 |
Last Verified: | September 2015 |
Additional relevant MeSH terms:
Hepatitis Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Interferons Ribavirin |
Interferon-alpha Peginterferon alfa-2a Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |