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) (GIFT-R)

AbbVie

Status and phase

Withdrawn

Phase 3

Conditions

Chronic Hepatitis C Virus

Treatments

Drug: Ombitasvir/paritaprevir/ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT02806362

M14-733

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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