BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

Hepatitis C Clinical Trial

Official title:

Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389323
• Other study ID #: AI444-038
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2011
• Last updated: September 19, 2015
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants chronically infected with Hepatitis C virus (HCV) genotype 1

• HCV RNA viral load of =10,000 IU/mL at screening

• No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent

• Self-described as Black-African American, Latino or White-Caucasian

• Results of a liver biopsy obtained =36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.

Compensated cirrhotics were capped at approximately 25%

Exclusion Criteria:

• Evidence of decompensated liver disease

• Documented or suspected Hepatocellular carcinoma (HCC)

• Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Daclatasvir
Tablet, Oral, 60 mg, once daily, 24 weeks
• Peg-Interferon Alfa-2a
Syringe, Subcutaneous Injection, 180 µg, Once weekly, 24 or 48 weeks depending on response
• Ribavirin
Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response

Locations

Country	Name	City	State
Puerto Rico	Local Institution	San Juan
United States	Metropolitan Research	Annandale	Virginia
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Atlanta Medical Center	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia
United States	Digestive Disease Associates, P.A.	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	University Of North Carolina At Chapel Hill School Of Med	Chapel Hill	North Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Baylor College Of Medicine	Houston	Texas
United States	Liver Associates Of Texas	Houston	Texas
United States	Research Specialists Of Texas	Houston	Texas
United States	Va Long Beach Healthcare System - 11	Long Beach	California
United States	Axis Clinical Trials	Los Angeles	California
United States	Greater Los Angeles Healthcare System	Los Angeles	California
United States	Miami V.A. Healthcare System	Maimi	Florida
United States	Loyola University Medical Center	Maywood	Illinois
United States	University Of Miami	Miami	Florida
United States	Alabama Liver & Digestive Specialists (Alds)	Montgomery	Alabama
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Digestive Health Center	Ocean Springs	Mississippi
United States	Florida Hospital Transplant Center	Orlando	Florida
United States	Oregon Health & Science University	Portland	Oregon
United States	Mcguire D V A M C	Richmond	Virginia
United States	University Of California, Davis Medical Center	Sacramento	California
United States	Brooke Army Medical Center	San Antonio	Texas
United States	Texas Liver Institute	San Antonio	Texas
United States	Medical Associates Research Group, Inc	San Diego	California
United States	Precision Research Institute, Llc	San Diego	California
United States	Ucsd Antiviral Research Center (Avrc)	San Diego	California
United States	The Research Institute	Springfield	Massachusetts
United States	Carolinas Center For Liver Disease	Statesville	North Carolina
United States	Infectious Disease Research Institute, Inc	Tampa	Florida
United States	South Florida Center Of Gastroenterology, P.A.	Wellington	Florida
United States	Triple O Research Institute, P.A.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)	SVR12 was defined as Hepatitis C Virus (HCV) RNA levels	Post-treatment Week 12	No
Secondary	Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene	SVR12 was defined as Hepatitis C Virus (HCV) RNA levels	Post-treatment Week 12	No
Secondary	Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points	The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels	Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24	No
Secondary	Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points	The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.	Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24	No
Secondary	Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died	An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.	From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])	Yes

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