Status:

COMPLETED

Peginterferon Alpha-2a Maintenance Therapy for Portal Hypertension in Patients With Hepatitis C

Lead Sponsor:

Virginia Commonwealth University

Collaborating Sponsors:

Roche Pharma AG

Conditions:

Hepatitis C

Cirrhosis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The primary purpose of this study is to determine if peginterferon alpha-2a maintenance therapy (90 mcg/week) will lower portal pressure in patients with hepatitis C virus infections and advanced fibr...

Detailed Description

Portal hypertension develops in patients with advanced fibrosis and cirrhosis and is the primary driving force leading to complications of cirrhosis, hepatic decompensation and mortality in patients w...

Eligibility Criteria

Inclusion

  • Completion of HALT-C Trial, in either treatment or non-treatment arm

Exclusion

  • Non-completion of HALT-C Trial
  • Patients who do not wish to be treated with peginterferon after the first portal pressure measurement
  • Hepatocellular Carcinoma
  • Underlying autoimmune disorder
  • Currently being treated with immune suppressive agent
  • Illicit drug use
  • Alcohol use of more than 6 grams per day
  • Advanced cardiopulmonary disease
  • Uncontrolled diabetes mellitus
  • Patients who, in the opinion of the investigator, should not participate in this trial

Key Trial Info

Start Date :

November 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2007

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00252642

Start Date

November 1 2005

End Date

September 1 2007

Last Update

March 20 2017

Active Locations (1)

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Virginia Commonwealth University

Richmond, Virginia, United States, 23298