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NCT03069365 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment
A Phase 3 study of Hepatitis C Virus (HCV), sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
- 20
- Study locations
NCT03069365: Completed Phase 3 study of Hepatitis C Virus (HCV), sponsored by AbbVie.
NCT03069365 is a Phase 3 study of Hepatitis C Virus (HCV) that has completed, run by AbbVie. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03069365, a Phase 3 study of Hepatitis C Virus (HCV), has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.
Primary Outcome
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Conditions Studied
Interventions
- DRUG Glecaprevir/pibrentasvir
Study Locations (20)
California
- Scripps Clinic /ID# 159116 - La Jolla
- Huntington Medical Foundation /ID# 160653 - Pasadena
New York
- North Shore University Hospital /ID# 159108 - New Hyde Park
- Columbia Univ Medical Center /ID# 159112 - New York
Pennsylvania
- University of Pennsylvania /ID# 159117 - Philadelphia
- Thomas Jefferson University /ID# 159754 - Philadelphia
British Columbia
- Vancouver ID Research and Care /ID# 160598 - Vancouver
- GIRI Gastrointestinal Research Institute /ID# 160599 - Vancouver
Other
- Med Hochschule Hanover /ID# 160827 - Hanover
- Univ Johannes Gutenberg /ID# 160828 - Mainz
Florida
- Tampa General Medical Group /ID# 159115 - Tampa
Louisiana
- Northwest Louisiana Nephrology /ID# 160652 - Shreveport
Massachusetts
- Massachusetts General Hospital /ID# 159114 - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2017-03-28 |
| Est. Completion | 2018-06-05 |
| Phase | Phase 3 |
What the finished NCT03069365 record still lists
NCT03069365 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Hepatitis C Virus (HCV) appearing as the primary indexed condition, and to 1 intervention - of which Glecaprevir/pibrentasvir is the first listed.
NCT03069365 names 20 study sites across 15 states, led by California, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03069365 about?
NCT03069365 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment". This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic...
What is the current status of trial NCT03069365?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2017-03-28. Estimated completion is 2018-06-05.
What conditions does trial NCT03069365 study?
This clinical trial studies the following conditions: Hepatitis C Virus (HCV).
What interventions are being tested in trial NCT03069365?
The interventions under investigation include: Glecaprevir/pibrentasvir (DRUG).
Who is sponsoring clinical trial NCT03069365?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03069365 being conducted?
This trial has 20 study locations across California, Florida, Louisiana, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C Virus (HCV)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03069365's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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