Timing and Duration of Acute Hepatitis C Treatment

This study has been completed.
Sponsor:
Collaborators:
University Hospital Freiburg
Beth Israel Deaconess Medical Center
Alexander von Humboldt Association
Fulbright
TEMPUS
International Society for Infectious Diseases
Information provided by:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT00241618
First received: October 18, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Pegylated interferon alpha 2
Drug: Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study of Treatment of Acute Hepatitis C With Pegylated Interferon

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • Sustained viral response rate in treatment group versus control

Secondary Outcome Measures:
  • End of treatment virologic response
  • Early virologic response at week 4
  • Quality of life

Estimated Enrollment: 180
Study Start Date: January 2002
Estimated Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241618

Locations
Egypt
Shebin Liver Center
Cairo, Egypt, 11351
ASU
Cairo, Egypt, 03316
ASU Specialized Hospital
Cairo, Egypt, 11351
Sponsors and Collaborators
Ain Shams University
University Hospital Freiburg
Beth Israel Deaconess Medical Center
Alexander von Humboldt Association
Fulbright
TEMPUS
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
Principal Investigator: Manal El Sayed, M.D. ASU
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00241618     History of Changes
Other Study ID Numbers: 994058402, AI054887, AI41563, Fulbright, TEMPUS, ISID
Study First Received: October 18, 2005
Last Updated: September 7, 2006
Health Authority: Egypt: Institutional Review Board
United States: Institutional Review Board

Keywords provided by Ain Shams University:
Clinical trial
Randomized
Treatment
Prospective
Parallel Assignment
Efficacy Safety Study

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014