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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)

NCT ID: NCT02806362

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis C Virus

Keywords

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Non-cirrhotic End Stage Renal Disease (ESRD) moderate fibrosis Chronic Hepatitis C Virus ( HCV) Chronic Hepatitis C Genotype 1b

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ombitasvir/paritaprevir/ritonavir (12 weeks)

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

Group Type EXPERIMENTAL

Ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

Tablet

Interventions

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Ombitasvir/paritaprevir/ritonavir

Tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Koji Kato, MD

Role: STUDY_DIRECTOR

AbbVie

Countries

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Japan

Other Identifiers

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M14-733

Identifier Type: -

Identifier Source: org_study_id