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

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

A mixed effect model for repeated measures (MMRM) was used to analyze HBsAg change from baseline, which included treatment, baseline HBsAg level (\> 5000 IU/mL or ≤ 5000 IU/mL), HBeAg baseline status (positive or negative), visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.

Conditions Studied

Chronic Hepatitis B

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
Gilead Sciences

504 total trials

What the finished NCT02166047 record still lists

NCT02166047 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 282-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (43% lower).

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 names 20 study sites across 10 states, led by 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.

Learn More About Clinical Trials

Similar trials for Chronic Hepatitis B

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 NCT02166047's enrollment target sits among peer trials

162 7th of 14 higher than 8 of 14 other Chronic Hepatitis B trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Hepatitis B 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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Related registry views

Source: ClinicalTrials.gov NCT02166047, the US trial registry maintained by the National Library of Medicine. NCT02166047 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.