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COMPLETED Phase 2

Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)

NCT02854631 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Prednisolone
  • DRUG Selonsertib

Study Locations (20)

Other

  • Medizinische Universitat Graz — Graz
  • Universitätsklinik für Innere Medizin I — Innsbruck
  • Medical University Vienna — Vienna
  • Cliniques Universitaires UCL Saint-Luc — Brussels
  • CUB Hopital Erasme — Brussels
  • Ghent University Hospital — Ghent
  • Universitair Ziekenhuis Leuven — Leuven
  • Centre Hospitalier Universitaire de Liege — Liège

California

  • Southern California Research Centers — Coronado
  • Cedars Sinai Medical Center — Los Angeles

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

Florida

  • Cleveland Clinic Florida — Weston

Louisiana

  • Oschner Medical Center — New Orleans

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston

Michigan

  • University of Michigan — Ann Arbor

Pennsylvania

  • University of Pennsylvania — Philadelphia

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2016-09-01
Est. Completion 2018-05-31
Phase Phase 2

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02854631

The ClinicalTrials.gov registry entry for NCT02854631 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Alcoholic Hepatitis (AH) appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02854631 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02854631 about?

NCT02854631 is a clinical study titled "Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)". The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).

What is the current status of trial NCT02854631?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2016-09-01. Estimated completion is 2018-05-31.

What conditions does trial NCT02854631 study?

This clinical trial studies the following conditions: Alcoholic Hepatitis (AH). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02854631?

The interventions under investigation include: Placebo (DRUG), Prednisolone (DRUG), Selonsertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02854631?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02854631 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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