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Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects

NCT03092375 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2020-02-26

Study results available
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Summary

The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.

Conditions

  • Hepatitis C
  • HCV

Interventions

DRUG

Glecaprevir/Pibrentasvir (G/P) 300mg/120mg

daily

DRUG

Ribavirin 200Mg Tablet

Weight-based 1000-1200 mg

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • AbbVie

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • David R Nelson, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2018-12-28
Completion
2020-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03092375 on ClinicalTrials.gov