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

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 ]