Timing and Duration of Acute Hepatitis C Treatment

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT00241618

Collaborator

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

180

Enrollment

Locations

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Pegylated interferon alpha 2 Drug: Ribavirin	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2002

Study Completion Date :

Jan 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	ASU	Cairo	Egypt	03316
2	ASU Specialized Hospital	Cairo	Egypt	11351
3	Shebin Liver Center	Cairo	Egypt	11351

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 Labs
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