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NCT01903798 · ClinicalTrials.gov registry record · Phase 2

A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis

A Phase 2 study, sponsored by Southern California Institute for Research and Education.

Completed
Registry status
Phase 2
Development phase
4
Enrollment target

NCT01903798 is a Phase 2 study that has completed, run by Southern California Institute for Research and Education. The registered enrollment target is 4 participants.

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The verdict

NCT01903798, a Phase 2 study, has completed, sponsored by Southern California Institute for Research and Education.

COMPLETED
Registry status
Phase 2
Development phase
4 participants
Enrollment target

Study Summary

This clinical trial will test two new therapies for the treatment of alcoholic hepatitis. Patients who "respond" to the current standard of care therapy for alcoholic hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly assigned to either continue on standard therapy, or, to begin treatment with rilonacept in combination with standard therapy. Patients who are "non-responders" to the current standard of care therapy after 1 week of treatment will be randomly assigned to standard of care or to begin treatment with mycophenolate mofetil in combination with standard therapy. Patients will be treated for a total of 4 weeks in this clinical trial. Patients will be followed for up to five months after completing therapy (6 months total).

Interventions

  • DRUG Prednisolone
  • DRUG Mycophenolate mofetil
  • DRUG Rilonacept

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2014-12
Est. Completion 2016-04
Phase Phase 2

What the Registry Record Tells You About NCT01903798

The ClinicalTrials.gov registry entry for NCT01903798 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Southern California Institute for Research and Education, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Prednisolone is the first listed.

NCT01903798 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01903798 about?

NCT01903798 is a clinical study titled "A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis". This clinical trial will test two new therapies for the treatment of alcoholic hepatitis. Patients who "respond" to the current standard of care therapy for alcoholic hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly assigned to either continue on standard the...

What is the current status of trial NCT01903798?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2014-12. Estimated completion is 2016-04.

What interventions are being tested in trial NCT01903798?

The interventions under investigation include: Prednisolone (DRUG), Mycophenolate mofetil (DRUG), Rilonacept (DRUG).

Who is sponsoring clinical trial NCT01903798?

This trial is sponsored by Southern California Institute for Research and Education, which has 13 total clinical trials registered on ClinicalTrials.gov.

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.