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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 is a Phase 3 study of Hepatitis C Virus (HCV) that has completed, run by AbbVie. The registered enrollment target is 101 participants. The trial reports 20 study locations across 15 states.

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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.

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

FieldValue
Enrollment Target 101 participants
Start Date 2017-03-28
Est. Completion 2018-06-05
Phase Phase 3

Sponsor

AbbVie

526 total trials

What the Registry Record Tells You About NCT03069365

The ClinicalTrials.gov registry entry for NCT03069365 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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