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

NCT02207088 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-11-09

Study results available
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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.

Conditions

  • Chronic Hepatitis C
  • Hepatitis C Virus
  • Compensated Cirrhosis
  • Severe Renal Impairment
  • End-stage Renal Disease

Interventions

DRUG

ombitasvir/paritaprevir/ritonavir

tablet

DRUG

dasabuvir

tablet

DRUG

Ribavirin

tablet

Sponsors & Collaborators

Principal Investigators

  • Eric Cohen, MD · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-23
Primary Completion
2016-12-06
Completion
2016-12-06

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207088 on ClinicalTrials.gov