Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P

Sponsor
Kirby Institute
Study ID
NCT02634008
Phase
PHASE3
Status
Completed

Conditions

  • Hepatitis C, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.

Key Dates

First listed
Dec 17, 2015
Start date
Jun 30, 2016
Status verified
Aug 2022
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021

Study Design

Enrollment
83 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Paritaprevir/ritonavir/ombitasvir (75mg/50mg/12.5mg) and dasabuvir (250mg) with or without ribavirin (1000-1200mg) daily taken orally for 8 weeks.
  • Experimental: Cohort 2
    Three tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 6 weeks
  • Experimental: Cohort 3
    Three tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 4 weeks

Primary Outcome Measure

Proportion of treated subjects (intention-to-treat (ITT) population) demonstrating undetectable hepatitis C virus (HCV) RNA at 12 weeks following treatment (SVR 12). [ Time Frame: 12 weeks post treatment ]