A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1

Phase 3

Completed

• Conditions: Hepatitis C Virus
• Interventions: Drug: DCV/ASV/BMS-791325

• Registration Number: NCT02170727
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.

Detailed Description

US National Institutes of Health Division of AIDs (DAIDS)

Study Timeline

• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Study Start: 2014-06-26
• Primary Completion: 2015-06-12
• Study Completion: 2015-09-09
• Disposition First Submitted: 2017-03-22
• Disposition First Submitted QC: 2017-03-22
• Disposition First Posted: 2017-03-23
• Results First Submitted: 2019-03-22
• Results First Submitted QC: 2019-07-09
• Results First Posted: 2019-08-16
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1 : DCV/ASV/BMS-791325	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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort	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	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	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	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	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	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)	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	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	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	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	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.

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Taoyuan, Taiwan