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NCT02166047 · ClinicalTrials.gov registry record · Phase 2

Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants

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

Completed
Registry status
Phase 2
Development phase
162
Enrollment target
20
Study locations

NCT02166047 is a Phase 2 study of Chronic Hepatitis B that has completed, run by Gilead Sciences. The registered enrollment target is 162 participants, below the 282-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT02166047, a Phase 2 study of Chronic Hepatitis B, has completed, sponsored by Gilead Sciences.

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

Study Summary

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Vesatolimod

Study Locations (20)

Other

  • - Milan
  • - Parma
  • - Pisa
  • - Rotterdam
  • - Auckland
  • - Seoul

California

  • - Los Angeles
  • - San Diego
  • - San Francisco
  • - San Jose

Massachusetts

  • - Boston
  • - Boston

Ontario

  • - Toronto
  • - Toronto

Hawaii

  • - Honolulu

Michigan

  • - Detroit

New York

  • - Flushing

British Columbia

  • - Vancouver

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2014-06-30
Est. Completion 2016-10-20
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT02166047

The ClinicalTrials.gov registry entry for NCT02166047 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 282-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (43% 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 Placebo is the first listed.

NCT02166047 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02166047 about?

NCT02166047 is a clinical study titled "Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants". The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). With...

What is the current status of trial NCT02166047?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2014-06-30. Estimated completion is 2016-10-20.

What conditions does trial NCT02166047 study?

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

What interventions are being tested in trial NCT02166047?

The interventions under investigation include: Placebo (DRUG), Vesatolimod (DRUG).

Who is sponsoring clinical trial NCT02166047?

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

Where is trial NCT02166047 being conducted?

This trial has 20 study locations across California, Hawaii, Massachusetts, Michigan, 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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