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

Hepatitis C Virus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170727
• Other study ID #: AI443-123
• Status: Completed
• Phase: Phase 3
• Start date: June 26, 2014
• Est. completion date: September 9, 2015

Study information

• Verified date: October 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

US National Institutes of Health Division of AIDs (DAIDS)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 9, 2015
• Est. primary completion date: June 12, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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, IFNa, pegIFNa), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)

• Interferon (IFN) experienced subject who have received previous treatment with IFNa, 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis C, Chronic

Intervention

Drug:
• DCV/ASV/BMS-791325

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Gyeonggi-Do
Korea, Republic of	Local Institution	Gyeongsangnam-do
Korea, Republic of	Local Institution	Inchoen
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Russian Federation	Local Institution	Kazan
Russian Federation	Local Institution	Moscow
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Tainan
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Korea, Republic of,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post treatment Week 12
Secondary	Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort	Percentage of treated participants with SVR12 in the IFNa experienced cohort, defined as HCV RNA < LLOQ target detected or target not detected (LLOQ TD/TND).	Post treatment Week 12
Secondary	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).	On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)
Secondary	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.	On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)
Secondary	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.	Up to post treatment week 4
Secondary	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.	Up to post treatment week 4
Secondary	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.	Post treatment week 12
Secondary	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.	Post treatment Week 12
Secondary	Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12	Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.	Post treatment Week 12
Secondary	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	Post treatment week 4
Secondary	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.	Up to post treatment week 4
Secondary	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.	Up to post treatment week 4

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry form