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Completed

NCT Number: NCT01389323

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daclatasvir

Drug

Tablet, Oral, 60 mg, once daily, 24 weeks

Other names: BMS-790052

PEG-interferon alfa-2a

Drug

Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response

Other names: Pegasys

Ribavirin

Drug

Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response

Other names: Copegus

Primary outcomes

  1. Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)

    Time frame: Post-treatment Week 12

    SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA 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.

Secondary outcomes

  1. 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

    Time frame: Post-treatment Week 12

    SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA 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.

  2. 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

    Time frame: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24

    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 <LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. 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.

  3. Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points

    Time frame: 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

    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.

  4. Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died

    Time frame: From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])

    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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 8, 2011
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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