Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

Bristol-Myers Squibb152 enrolled

Overview

The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

152

Conditions

Hepatitis C

Interventions

BMS-790052 (NS5A Replication Complex Inhibitor)DRUG

Placebo matching BMS-790052DRUG

Pegylated-interferon alfa 2aDRUG

RibavirinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants chronically infected with HCV Genotype 4 * HCV RNA viral load of ≥ 10,000 IU/mL * No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent * Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted Exclusion Criteria: * Evidence of decompensated liver disease * Documented or suspected Hepatocellular carcinoma (HCC) * Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening

Locations (26)

Scti Research Foundation

San Clemente, California, United States

Outcomes

Primary Outcomes

Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)

Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels \< lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.

Time frame: Week 12 (Follow-up period)

Secondary Outcomes

Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)

Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.

Time frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48

Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels

Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.

Time frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene

Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.

Time frame: Post Treatment Weeks 12, 24

Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died

Data from ClinicalTrials.gov

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