GIFT-R: 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)

Sponsor

AbbVie (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02806362

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Virus	Drug: Ombitasvir/paritaprevir/ritonavir	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease on Hemodialysis (GIFT-R)

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ombitasvir/paritaprevir/ritonavir (12 weeks) Ombitasvir/paritaprevir/ritonavir (25/50/100mg once daily) for 12 weeks	Drug: Ombitasvir/paritaprevir/ritonavir Tablet

Arm

Intervention/Treatment

Experimental: Ombitasvir/paritaprevir/ritonavir (12 weeks)

Ombitasvir/paritaprevir/ritonavir (25/50/100mg once daily) for 12 weeks

Drug: Ombitasvir/paritaprevir/ritonavir

Tablet

Outcome Measures

Primary Outcome Measures

Percentage of participants achieving a 12-week sustained virologic response (SVR12). [12 weeks after the last dose of study drug]
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.

Secondary Outcome Measures

Percentage of participants with on-treatment virologic failure [Up to Week 12]
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.
Percentage of participants with relapse [Up to 12 weeks after the last dose of study drug]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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