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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) (GIFT-R)

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AbbVie

Status and phase

Withdrawn
Phase 3

Conditions

Chronic Hepatitis C Virus

Treatments

Drug: Ombitasvir/paritaprevir/ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT02806362
M14-733

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Ombitasvir/paritaprevir/ritonavir (12 weeks)
Experimental group
Description:
Ombitasvir/paritaprevir/ritonavir (25/50/100mg once daily) for 12 weeks
Treatment:
Drug: Ombitasvir/paritaprevir/ritonavir

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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