Back to resultsStudy 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)
Primary Purpose
Chronic Hepatitis C Virus
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ombitasvir/paritaprevir/ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Virus focused on measuring Non-cirrhotic, End Stage Renal Disease (ESRD), moderate fibrosis, Chronic Hepatitis C Virus ( HCV), Chronic Hepatitis C Genotype 1b
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ombitasvir/paritaprevir/ritonavir (12 weeks)
Arm Description
Ombitasvir/paritaprevir/ritonavir (25/50/100mg once daily) for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02806362
Brief Title
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)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prematurely, prior to enrollment of first participant
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Virus
Keywords
Non-cirrhotic, End Stage Renal Disease (ESRD), moderate fibrosis, Chronic Hepatitis C Virus ( HCV), Chronic Hepatitis C Genotype 1b
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ombitasvir/paritaprevir/ritonavir (12 weeks)
Arm Type
Experimental
Arm Description
Ombitasvir/paritaprevir/ritonavir (25/50/100mg once daily) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ombitasvir/paritaprevir/ritonavir
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Percentage of participants achieving a 12-week sustained virologic response (SVR12).
Description
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 Outcome Measure Information:
Title
Percentage of participants with on-treatment virologic failure
Description
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
Title
Percentage of participants with relapse
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koji Kato, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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)
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