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Sponsors and Collaborators: |
Ain Shams University University Hospital Freiburg Beth Israel Deaconess Medical Center Alexander von Humboldt Association Fulbright National Institute of Allergy and Infectious Diseases (NIAID) TEMPUS International Society of Infectious Diseases |
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Information provided by: | Ain Shams University |
ClinicalTrials.gov Identifier: | NCT00241618 |
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 |
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Hepatitis C |
Drug: Pegylated interferon alpha 2 Drug: Ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IV Study of Treatment of Acute Hepatitis C With Pegylated Interferon |
Estimated Enrollment: | 180 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | January 2006 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Egypt | |
Shebin Liver Center | |
Cairo, Egypt, 11351 | |
ASU | |
Cairo, Egypt, 03316 | |
ASU Specialized Hospital | |
Cairo, Egypt, 11351 |
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 University |
Principal Investigator: | Manal El Sayed, M.D. | ASU |
Study ID Numbers: | 994058402, AI054887, AI41563, Fulbright, TEMPUS, ISID |
Study First Received: | October 18, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00241618 History of Changes |
Health Authority: | Egypt: Institutional Review Board; United States: Institutional Review Board |
Clinical trial Randomized Treatment |
Prospective Parallel Assignment Efficacy Safety Study |
Interferon-alpha Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Immunologic Factors |
Interferons Ribavirin Hepatitis, Viral, Human Hepatitis C Interferon Alfa-2a Antiviral Agents |
Interferon-alpha Anti-Infective Agents Liver Diseases RNA Virus Infections Flaviviridae Infections Immunologic Factors Antineoplastic Agents Interferons Physiological Effects of Drugs |
Hepatitis, Viral, Human Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Hepatitis C |