UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
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| ClinicalTrials.gov Identifier: NCT01973049 |
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Recruitment Status :
Completed
First Posted : October 31, 2013
Last Update Posted : October 9, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C | Drug: Daclatasvir Drug: Asunaprevir Drug: BMS-791325 Drug: Ribavirin Drug: Placebo matching Ribavirin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 202 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis |
| Study Start Date : | December 2013 |
| Actual Primary Completion Date : | August 2014 |
| Actual Study Completion Date : | November 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive)
Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0mg tablet orally twice a day for 12 weeks |
Drug: Daclatasvir
Other Name: BMS-790052 Drug: Asunaprevir Other Name: BMS-650032 Drug: BMS-791325 Drug: Placebo matching Ribavirin |
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Experimental: A2: DCV/ASV/BMS-791325 + RBV (naive)
Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200mg tablet orally twice a day for 12 weeks |
Drug: Daclatasvir
Other Name: BMS-790052 Drug: Asunaprevir Other Name: BMS-650032 Drug: BMS-791325 Drug: Ribavirin Other Name: Ribasphere® |
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Experimental: A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)
Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0 mg tablet orally twice a day for 12 weeks |
Drug: Daclatasvir
Other Name: BMS-790052 Drug: Asunaprevir Other Name: BMS-650032 Drug: BMS-791325 Drug: Placebo matching Ribavirin |
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Experimental: A4: DCV/ASV/BMS-791325 + RBV (experienced)
Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200 mg tablet orally twice a day for 12 weeks, Weight based dosing: If < 75 kg, 1000 mg per day (two 200 mg tablets in AM and three 200 mg tablets in PM); if ≥ 75 kg, 1200 mg per day (three 200 mg tablets in AM and three 200 mg tablets in PM), AM=in the morning, PM=in the evening |
Drug: Daclatasvir
Other Name: BMS-790052 Drug: Asunaprevir Other Name: BMS-650032 Drug: BMS-791325 Drug: Ribavirin Other Name: Ribasphere® |
- Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) [ Time Frame: Post treatment 12 week ]SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) < Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)
- Proportion of treated subjects in each of the experienced arms with SVR12 [ Time Frame: Post treatment 12 Week ]
- Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND [ Time Frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) ]
- Proportion of subjects in each arm who achieve HCV RNA < LOQ TND [ Time Frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24) ]
- Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs) [ Time Frame: Up to end of treatment (week 12) + 7 days ]
- Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg ≥ 10 g/dL at baseline in each arm within each cohort [ Time Frame: Up to end of treatment (week 12) + 7 days ]
- Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities [ Time Frame: Up to end of treatment (week 12) + 7 days ]
- Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b [ Time Frame: Post treatment 12 Week ]
- Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype) [ Time Frame: Post treatment 12 Week ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects chronically infected with HCV genotype 1
- Subjects with compensated cirrhosis
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV Direct Acting Antivirals (DAA) (protease, polymerase inhibitor, etc.)
- Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir (ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B (NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.
Exclusion Criteria:
- Subjects without cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to screening
- Documented or suspected hepatocellular carcinoma(HCC)
- Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
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): NCT01973049
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01973049 |
| Other Study ID Numbers: |
AI443-113 2013-002458-66 ( EudraCT Number ) |
| First Posted: | October 31, 2013 Key Record Dates |
| Last Update Posted: | October 9, 2015 |
| Last Verified: | September 2015 |
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Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Hepatitis, Chronic Ribavirin Asunaprevir Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Protease Inhibitors Enzyme Inhibitors |