Timing and Duration of Acute Hepatitis C Treatment

September 7, 2006 updated by: Ain Shams University

Phase IV Study of Treatment of Acute Hepatitis C With Pegylated Interferon

Spontaneous resolution of acute hepatitis C infection cannot be predicted and the majority of cases persist and become chronic. This randomized trial assesses the efficacy and safety of peginterferon alfa-2b. The investigators hypothesize that therapy strategies could prevent the development of chronic hepatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With nearly 4 million people in the United States, and an estimated 170-200 million people worldwide, the hepatitis C virus (HCV) represents a clear and significant public health issue. Unfortunately, for most people infected with HCV (70%-85%) spontaneous resolution is uncommon and 60% to 80% of patients with acute hepatitis C infection develop chronic hepatitis. This randomized trial focuses on defining the effect of treatment of acute HCV on prevention of chronic hepatitis in addition to optimization of the treatment regimen, onset and the length of peginterferon alpha therapy in acute hepatitis C infections. This randomized, multi-center prospective study assesses the efficacy of peginterferon in acute hepatitis. We will also compare differences in sustained viral response rates in patients with acute hepatitis C starting treatment at 8, 12, or 24 weeks. We will also compare the efficacy of 8, 12 or 24 weeks therapy with PEG-IFN-alpha. All eligible patients are enrolled and screened for an initial observation period starting from the time of their first positive HCV-RNA-PCR, during which bi-weekly serum ALT and HCV-RNA subjects were performed. Patients who did not resolve spontaneously (loss of HCV-RNA without treatment) by the end of the observation period were randomly assigned to receive PEG-IFN-alpha at the assigned onset and/or duration. Patients who do not consent to therapy at enrollment are included as a non-randomized comparison group. All subjects with SVR were followed for 48 weeks after the follow-up at 24 weeks when SVR was determined.

Study Type

Interventional

Enrollment

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 03316
        • ASU
      • Cairo, Egypt, 11351
        • ASU Specialized Hospital
      • Cairo, Egypt, 11351
        • Shebin Liver Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-50 years, with or without symptoms
  • Diagnosis of acute hepatitis C: elevated serum alanine aminotransferase (ALT) > 10 times the upper limit of normal (ULN)
  • Seroconversion from negative to positive anti-HCV antibody status (third-generation enzyme-linked immunosorbent assay)
  • Conversion from negative to positive polymerase chain reaction (PCR) for HCV-RNA, ruling out other causes of hepatitis by history and appropriate serologic and virologic studies.

Exclusion Criteria:

  • Decompensated liver disease
  • Coinfection with human immunodeficiency virus (HIV) or Schistosoma mansoni
  • Marked anemia (hemoglobin level ≤ 120 g/L in women and ≤ 130 g/L in men)
  • Neutropenia (< 1,500/mm3)
  • Thrombocytopenia (< 90,000/mm3)
  • A creatinine concentration > 1.5 times ULN
  • Serum alpha-fetoprotein > 25 ng/ml
  • An organ transplant
  • Neoplastic disease
  • Severe cardiac or pulmonary disease
  • Unstable thyroid dysfunction
  • A psychiatric disorder
  • Seizure disorder
  • Severe retinopathy
  • A current pregnancy or were breast feeding or unwillingness to practice contraception
  • Therapy with immunomodulatory agents within the last 6 months
  • Alcohol or drug dependence within 1 year of study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sustained viral response rate in treatment group versus control

Secondary Outcome Measures

Outcome Measure
Quality of life
End of treatment virologic response
Early virologic response at week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Beth Israel Deaconess Medical Center
University Hospital Freiburg
Tempus Labs
Fulbright
Alexander von Humboldt Association
International Society for Infectious Diseases

Investigators

  • Study Chair: Alaa Ismail, M.D., ain shams University
  • Principal Investigator: Sanaa M Kamal, M.D., ain shams University
  • Principal Investigator: Nezam H Afdhal, M.D., Harvard Medical School (HMS and HSDM)
  • Principal Investigator: Manal El Sayed, M.D., ASU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

October 18, 2005

First Submitted That Met QC Criteria

October 18, 2005

First Posted (Estimate)

October 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 11, 2006

Last Update Submitted That Met QC Criteria

September 7, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 994058402
  • AI054887
  • AI41563
  • Fulbright
  • TEMPUS
  • ISID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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