Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients

Conditions

• Hepatitis C, Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• glecaprevir (300mg)/pibrentasvir (120mg) — DRUG
  glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks

Study Details

The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified. Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification. Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks. One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).

Key Dates

Start date

Aug 21, 2017

Status verified

Dec 2019

Primary completion

Dec 19, 2018

Completion

Dec 19, 2018

Study Design

Enrollment

380 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Standard monitoring schedule
  Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
• Experimental: Simplified monitoring schedule
  Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.

Primary Outcome Measure

Undetectable HCV RNA (ITT Population) [ Time Frame: 12 weeks post end of treatment (SVR12) ]

Locations (4)

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