Back to resultsA Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (UNITY 4)
Primary Purpose
Hepatitis C Virus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DCV/ASV/BMS-791325
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus
Eligibility Criteria
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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1 : DCV/ASV/BMS-791325
Arm Description
DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
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
Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort
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
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
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
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
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
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)
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
Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02170727
Brief Title
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Acronym
UNITY 4
Official Title
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2014 (Actual)
Primary Completion Date
June 12, 2015 (Actual)
Study Completion Date
September 9, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 : DCV/ASV/BMS-791325
Arm Type
Experimental
Arm Description
DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
DCV/ASV/BMS-791325
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
Description
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.
Time Frame
Post treatment Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort
Description
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).
Time Frame
Post treatment Week 12
Title
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Description
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).
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)
Title
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Description
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.
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)
Title
Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
Description
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.
Time Frame
Up to post treatment week 4
Title
Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline
Description
Anemia was defined as hemoglobin < 10 g/dL on-treatment for subjects who had hemoglobin >= 10 g/dL at baseline.
Time Frame
Up to post treatment week 4
Title
Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b
Description
Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.
Time Frame
Post treatment week 12
Title
Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)
Description
Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
Time Frame
Post treatment Week 12
Title
Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12
Description
Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
Time Frame
Post treatment Week 12
Title
Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Description
Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated
Time Frame
Post treatment week 4
Title
Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs
Description
Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.
Time Frame
Up to post treatment week 4
Title
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Description
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.
Time Frame
Up to post treatment week 4
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-Do
ZIP/Postal Code
480-717
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
Local Institution
City
Inchoen
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Local Institution
City
Kazan
ZIP/Postal Code
420140
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
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