Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)

AbbVie

Overview

The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Chronic Hepatitis C Virus

Interventions

Ombitasvir/paritaprevir/ritonavirDRUG

Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile * Hepatitis C Virus (HCV) Ribonucleic acid (RNA) greater than 10,000 IU/mL at Screening * Chronic HCV, Genotype (GT)1b infection * Treatment-naive or treatment-experienced with an interferon (IFN)-containing regimen (IFN or pegylated-IFN with or without ribavirin). * A fibrosis assessment test result equivalent to Metavir F0-F2. Exclusion Criteria: * Presence of Y93H variant at Screening * Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human immunodeficiency virus antibody (HIV Ab) * Significant liver disease with any cause other than chronic HCV infection * On peritoneal dialysis * On hemodialysis for more than 15 years

Outcomes

Primary Outcomes

Percentage of participants achieving a 12-week sustained virologic response (SVR12).

SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.

Time frame: 12 weeks after the last dose of study drug

Secondary Outcomes

Percentage of participants with on-treatment virologic failure

On-treatment virologic failure was defined as the following: Confirmed increase from nadir in HCV RNA (2 consecutive HCV RNA measurements greater than 1 log10 IU/mL above nadir) at any time point during treatment; or Confirmed HCV RNA greater than or equal to LLOQ after HCV RNA is less than LLOQ during treatment; or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks of treatment.

Time frame: Up to Week 12

Percentage of participants with relapse

Participants with a confirmed HCV RNA greater than or equal to the LLOQ between Final treatment visit and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA less than LLOQ at Final treatment visit.

Time frame: Up to 12 weeks after the last dose of study drug

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.