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)

Chronic Hepatitis C Virus Clinical Trial

— GIFT-R  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02806362
• Other study ID #: M14-733
• Status: Withdrawn
• Phase: Phase 3
• First received: June 16, 2016
• Last updated: December 2, 2016
• Start date: September 2016
• Est. completion date: August 2018

Study information

• Verified date: December 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Ombitasvir/paritaprevir/ritonavir
Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks after the last dose of study drug	No
Secondary	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.	Up to Week 12	No
Secondary	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.	Up to 12 weeks after the last dose of study drug	No