A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (UNITY 4)
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ClinicalTrials.gov Identifier: NCT02170727 |
Recruitment Status :
Completed
First Posted : June 23, 2014
Results First Posted : August 16, 2019
Last Update Posted : October 29, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C Virus | Drug: DCV/ASV/BMS-791325 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 199 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 |
Actual Study Start Date : | June 26, 2014 |
Actual Primary Completion Date : | June 12, 2015 |
Actual Study Completion Date : | September 9, 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 : DCV/ASV/BMS-791325
DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
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Drug: DCV/ASV/BMS-791325 |
- Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort [ Time Frame: Post treatment Week 12 ]Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
- Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort [ Time Frame: Post treatment Week 12 ]Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LLOQ target detected or target not detected (LLOQ TD/TND).
- Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND [ Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment) ]Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).
- Percentage of Participants Who Achieved HCV RNA < LLOQ TND [ Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment) ]Percentage of treated participants with HCV RNA < LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.
- Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment [ Time Frame: Up to post treatment week 4 ]SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.
- Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline [ Time Frame: Up to post treatment week 4 ]Anemia was defined as hemoglobin < 10 g/dL on-treatment for subjects who had hemoglobin >= 10 g/dL at baseline.
- Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b [ Time Frame: Post treatment week 12 ]Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.
- Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype) [ Time Frame: Post treatment Week 12 ]Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
- Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12 [ Time Frame: Post treatment Week 12 ]Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
- Number of Participants With Selected Grade 3/4 Laboratory Abnormalities [ Time Frame: Post treatment week 4 ]Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated
- Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs [ Time Frame: Up to post treatment week 4 ]Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.
- Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities [ Time Frame: Up to post treatment week 4 ]Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.

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Ages Eligible for Study: | Child, 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:
- Subject chronically infected with HCV genotype 1 (GT-1)
- Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
- Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV
Exclusion Criteria:
- Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
- Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed);
- 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): NCT02170727
Korea, Republic of | |
Local Institution | |
Busan, Korea, Republic of, 602-739 | |
Local Institution | |
Busan, Korea, Republic of, 614-735 | |
Local Institution | |
Gyeonggi-do, Korea, Republic of, 463-707 | |
Local Institution | |
Gyeonggi-Do, Korea, Republic of, 480-717 | |
Local Institution | |
Gyeongsangnam-do, Korea, Republic of, 626-770 | |
Local Institution | |
Inchoen, Korea, Republic of, 405-760 | |
Local Institution | |
Seoul, Korea, Republic of, 120-752 | |
Local Institution | |
Seoul, Korea, Republic of, 135-710 | |
Local Institution | |
Seoul, Korea, Republic of, 138-736 | |
Local Institution | |
Seoul, Korea, Republic of, 156-755 | |
Russian Federation | |
Local Institution | |
Kazan, Russian Federation, 420140 | |
Local Institution | |
Moscow, Russian Federation, 109240 | |
Taiwan | |
Local Institution | |
Kaohsiung, Taiwan, 807 | |
Local Institution | |
Kaohsiung, Taiwan, 833 | |
Local Institution | |
Taichung, Taiwan, 40447 | |
Local Institution | |
Taichung, Taiwan, 40705 | |
Local Institution | |
Tainan, Taiwan, 704 | |
Local Institution | |
Taipei, Taiwan, 100 | |
Local Institution | |
Taipei, Taiwan, 112 | |
Local Institution | |
Taoyuan, Taiwan, 333 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02170727 |
Other Study ID Numbers: |
AI443-123 |
First Posted: | June 23, 2014 Key Record Dates |
Results First Posted: | August 16, 2019 |
Last Update Posted: | October 29, 2020 |
Last Verified: | October 2020 |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Hepatitis, Chronic |