Study with PegInterferon Alfa-2a, Ribavirin and BMS-790052 with or without BMS-650032 for participants in some HCV trials

An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C Revised Protocol Number 05; Incorporates Amendment 10 and Administrative Letter 02

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000836-27-IE

Enrollment

330

Registered

2011-08-05

Start date

2011-09-30

Completion date

Unknown

Last updated

2016-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HEPATITIS C VIRUS MedDRA version: 16.0 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 100000004848

Interventions

Product Name: BMS-790052 Product Code: Daclatasvir Pharmaceutical Form: Film-coated tablet INN or Proposed INN: daclatasvir Current Sponsor code: BMS-790052 Other descriptive name: HCV NS5A Replicatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Prior participation in any BMS-790052, BMS-650032, BMS-791325 trial and assigned to control arm during the trial. • HCV genotype 1, 2, 3, or 4 (mixed genotypes are not permitted) • HCV RNA viral load detectable • Refer to Protocol section 3.3.1 for contraception requirements specific to subjects on TRIPLE or QUAD therapy, and on DUAL therapy. 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 317 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13

Exclusion criteria

Exclusion criteria: • Discontinuation from prior BMS HCV clinical trial due to a peginterferon/ribavirin-related event • Any anti-HCV therapy with following BMS-650032, BMS-790052 or BMS-791325; • Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening; • Evidence of medical condition associated with chronic liver disease other than HCV; • Evidence of decompensated cirrhosis including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy • Uncontrolled diabetes; • Confirmed, uncontrolled hypertension; • Moderate to severe depression; • History of severe psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy based on the proportion of subjects with SVR12, defined as HCV RNA<LOQ at follow-up Week 12, for all subjects infected with HCV genotype 1 who are prior non-responders to pegIFNa-2a/RBV.;Secondary Objective: • To assess efficacy, as determined by the proportion of subjects with SVR12 for HCV genotype 2, 3, and 4 prior non-responders to pegIFNa-2a/RBV and treatment naive HCV genotype 1b; • To assess safety, as measured by the frequency of SAEs and discontinuations due toAEs for each treatment regimen; • To assess efficacy, as determined by the proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 [VR (4&12)], EOT, or follow-up Week 24 (SVR24) for each HCV genotype and treatment regimen; • To assess efficacy, as determined by the proportion of subjects who achieve HCV RNA undetectable at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 (eRVR), EOT, follow-up Week 12, or follow-up Week 24 for each HCV genotype and treatment regimen; • To describe drug-resistant variants associated with virologic failure for each HCVgenotype and treatment regimen. See Protocol section 1.3.3 for additional exploratory objectives.;Primary end point(s): Proportion of subjects with SVR12, defined as HCV RNA<LOQ at followup Week 12, for all subjects infected with HCV genotype 1 who are prior non-responders to pegIFNa-2a/RBV;Timepoint(s) of evaluation of this end point: Follow-up Week 12	—

Measure

Time frame

Main Objective: To assess the efficacy based on the proportion of subjects with SVR12, defined as HCV RNA<LOQ at follow-up Week 12, for all subjects infected with HCV genotype 1 who are prior non-responders to pegIFNa-2a/RBV.;Secondary Objective: • To assess efficacy, as determined by the proportion of subjects with SVR12 for HCV genotype 2, 3, and 4 prior non-responders to pegIFNa-2a/RBV and treatment naive HCV genotype 1b; • To assess safety, as measured by the frequency of SAEs and discontinuations due toAEs for each treatment regimen; • To assess efficacy, as determined by the proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 [VR (4&12)], EOT, or follow-up Week 24 (SVR24) for each HCV genotype and treatment regimen; • To assess efficacy, as determined by the proportion of subjects who achieve HCV RNA undetectable at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 (eRVR), EOT, follow-up Week 12, or follow-up Week 24 for each HCV genotype and treatment regimen; • To describe drug-resistant variants associated with virologic failure for each HCVgenotype and treatment regimen. See Protocol section 1.3.3 for additional exploratory objectives.;Primary end point(s): Proportion of subjects with SVR12, defined as HCV RNA<LOQ at followup Week 12, for all subjects infected with HCV genotype 1 who are prior non-responders to pegIFNa-2a/RBV;Timepoint(s) of evaluation of this end point: Follow-up Week 12

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of subjects with SVR12, defined as HCV RNA<LOQ at followup Week 12, for each HCV genotype other than genotype 1 prior nonresponders to pegIFNa-2a/RBV and treatment naive HCV genotype 1b; • Frequency of SAEs and discontinuations due to AEs; • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 [VR (4 & 12)], EOT, or follow-up Week 24 (SVR24) for each HCV genotype and treatment regimen; • Proportion of subjects who achieve HCV RNA undetectable at Weeks: 1, 2, 4, 6, 8,and 12, Weeks 4 and 12 (eRVR), EOT, follow-up Week 12 , or follow-up Week 24 for each HCV genotype and treatment regimen; • Frequency of genotypic substitutions associated with virologic failure for each HCV genotype and treatment regimen.;Timepoint(s) of evaluation of this end point: 1) Follow-up Week 12 2) Duration of trial 3) Weeks 1, 2, 4, 6, 8, 12, 24, followup week 12 & 24 4) End of Trial	—

Measure

Time frame

Secondary end point(s): • Proportion of subjects with SVR12, defined as HCV RNA<LOQ at followup Week 12, for each HCV genotype other than genotype 1 prior nonresponders to pegIFNa-2a/RBV and treatment naive HCV genotype 1b; • Frequency of SAEs and discontinuations due to AEs; • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 [VR (4 & 12)], EOT, or follow-up Week 24 (SVR24) for each HCV genotype and treatment regimen; • Proportion of subjects who achieve HCV RNA undetectable at Weeks: 1, 2, 4, 6, 8,and 12, Weeks 4 and 12 (eRVR), EOT, follow-up Week 12 , or follow-up Week 24 for each HCV genotype and treatment regimen; • Frequency of genotypic substitutions associated with virologic failure for each HCV genotype and treatment regimen.;Timepoint(s) of evaluation of this end point: 1) Follow-up Week 12 2) Duration of trial 3) Weeks 1, 2, 4, 6, 8, 12, 24, followup week 12 & 24 4) End of Trial

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Countries

Argentina, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Puerto Rico, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactEU Study Start Up Unit

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026