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NCT01590641 · ClinicalTrials.gov registry record · Phase 1

A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B

A Phase 1 study of Hepatitis B and HBV, sponsored by Gilead Sciences.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target
20
Study locations

NCT01590641 is a Phase 1 study of Hepatitis B and HBV that has completed, run by Gilead Sciences. The registered enrollment target is 49 participants, below the 1,627-participant average among 32 other Hepatitis B trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 18 states.

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The verdict

NCT01590641, a Phase 1 study of Hepatitis B and HBV, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target
20
Study locations

Study Summary

Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments

Conditions Studied

Hepatitis B HBV

Interventions

  • DRUG Single Ascending Dose (SAD) Cohorts GS-9620
  • DRUG Multiple Ascending Dose (MAD) Cohorts

Study Locations (20)

California

  • West Coast Clinical Trials, LLC - Costa Mesa
  • University of California Antiviral Research Center (AVRC) - San Diego

Alberta

  • University of Calgary, Heritage Medical Research Center - Calgary
  • University of Alberta Hospital - Edmonton

Arizona

  • Mayo Clinic Hospital - Phoenix

Indiana

  • Indiana University Medical Center - Indianapolis

Louisiana

  • Tulane University Health Sciences Center - New Orleans

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

Michigan

  • Henry Ford Health System - Detroit

Missouri

  • Kansas City Gastroenterology and Hepatology - Kansas City

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2012-04
Est. Completion 2013-10
Phase Phase 1

Sponsor

Gilead Sciences

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01590641

The ClinicalTrials.gov registry entry for NCT01590641 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,627-participant average among 32 other Hepatitis B trials with a reported enrollment target (97% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Hepatitis B appearing as the primary indexed condition, and to 2 interventions - of which Single Ascending Dose (SAD) Cohorts GS-9620 is the first listed.

NCT01590641 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, Alberta, Arizona.

Frequently Asked Questions

What is clinical trial NCT01590641 about?

NCT01590641 is a clinical study titled "A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B". Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required perio...

What is the current status of trial NCT01590641?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-04. Estimated completion is 2013-10.

What conditions does trial NCT01590641 study?

This clinical trial studies the following conditions: Hepatitis B, HBV.

What interventions are being tested in trial NCT01590641?

The interventions under investigation include: Single Ascending Dose (SAD) Cohorts GS-9620 (DRUG), Multiple Ascending Dose (MAD) Cohorts (DRUG).

Who is sponsoring clinical trial NCT01590641?

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

Where is trial NCT01590641 being conducted?

This trial has 20 study locations across Arizona, California, Indiana, Louisiana, Massachusetts. 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.