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NCT02174276 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment

A Phase 2 study of Chronic Hepatitis B, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
195
Enrollment target
20
Study locations

NCT02174276 is a Phase 2 study of Chronic Hepatitis B that has completed, run by Gilead Sciences. The registered enrollment target is 195 participants, below the 280-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT02174276, a Phase 2 study of Chronic Hepatitis B, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
195 participants
Enrollment target
20
Study locations

Study Summary

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.

Conditions Studied

Chronic Hepatitis B

Interventions

  • DRUG Tenofovir disoproxil fumarate
  • BIOLOGICAL GS-4774

Study Locations (20)

California

  • Stanford University Medical Center - Palo Alto
  • Kaiser Permanente - Sacramento
  • Research and Education, Inc. - San Diego
  • Kaiser Permanente San Francisco - San Francisco
  • Silicon Valley Research Institute - San Jose

Ontario

  • Toronto General Hospital-The University Health Network - Toronto
  • Toronto Liver Centre - Toronto
  • Toronto Western Hospital-The University Health Network - Toronto

Virginia

  • Virginia Commonwealth University - Richmond
  • Kaiser Permanente - Springfield

British Columbia

  • Gordon & Leslie Diamond Health Care Centre - Vancouver
  • Liver and Intestinal Research Center - Vancouver

Other

  • Aou-S.Orsola-Malpighi - Universita Degli Studi Di - Bologna
  • Azienda Ospedaliero-Universitaria di Parma - Parma

Hawaii

  • The Queen's Medical Center - Honolulu

Maryland

  • Digestive Disease Associates, PA - Baltimore

Massachusetts

  • Tufts Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2014-07-24
Est. Completion 2018-05-30
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

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What the Registry Record Tells You About NCT02174276

The ClinicalTrials.gov registry entry for NCT02174276 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 280-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (30% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Hepatitis B appearing as the primary indexed condition, and to 2 interventions - of which Tenofovir disoproxil fumarate is the first listed.

NCT02174276 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Ontario, Virginia.

Frequently Asked Questions

What is clinical trial NCT02174276 about?

NCT02174276 is a clinical study titled "Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment". The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All pa...

What is the current status of trial NCT02174276?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2014-07-24. Estimated completion is 2018-05-30.

What conditions does trial NCT02174276 study?

This clinical trial studies the following conditions: Chronic Hepatitis B.

What interventions are being tested in trial NCT02174276?

The interventions under investigation include: Tenofovir disoproxil fumarate (DRUG), GS-4774 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02174276?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02174276 being conducted?

This trial has 20 study locations across California, Hawaii, Maryland, 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.