Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease

Chronic Hepatitis C Clinical Trial

Official title:

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207088
• Other study ID #: M14-226
• Secondary ID: 2014-001527-77
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2014
• Last updated: October 13, 2017
• Start date: September 23, 2014
• Est. completion date: December 6, 2016

Study information

• Verified date: October 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30, including those on hemodialysis or peritoneal dialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 6, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening.

2. Screening laboratory result indicating HCV genotype 1 infection.

3. Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment).

4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).

3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Compensated Cirrhosis
• End-stage Renal Disease
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Kidney Diseases
• Kidney Failure, Chronic
• Liver Cirrhosis
• Renal Insufficiency
• Severe Renal Impairment

Intervention

Drug:
• ombitasvir/paritaprevir/ritonavir
tablet
• dasabuvir
tablet
• Ribavirin
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 With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as confirmed HCV RNA = LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA = LLOQ persistently during treatment with at least 6 weeks of treatment.	Up to 24 weeks
Secondary	Percentage of Participants With Post-Treatment Relapse	Post-treatment relapse was defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.	Within 12 weeks after the last dose of study drug