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Timing and Duration of Acute Hepatitis C Treatment
This study has been completed.
First Received: October 18, 2005   Last Updated: September 7, 2006   History of Changes
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
Information provided by: Ain Shams University
ClinicalTrials.gov Identifier: NCT00241618
  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 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

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
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 of 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 University
Principal Investigator: Manal El Sayed, M.D. ASU
  More Information

Publications:
Kamal SM, Ismail A, Graham CS, He Q, Rasenack JW, Peters T, Tawil AA, Fehr JJ, Khalifa Kel S, Madwar MM, Koziel MJ. Pegylated interferon alpha therapy in acute hepatitis C: relation to hepatitis C virus-specific T cell response kinetics. Hepatology. 2004 Jun;39(6):1721-31.
Gerlach JT, Diepolder HM, Zachoval R, Gruener NH, Jung MC, Ulsenheimer A, Schraut WW, Schirren CA, Waechtler M, Backmund M, Pape GR. Acute hepatitis C: high rate of both spontaneous and treatment-induced viral clearance. Gastroenterology. 2003 Jul;125(1):80-8.
Nomura H, Sou S, Tanimoto H, Nagahama T, Kimura Y, Hayashi J, Ishibashi H, Kashiwagi S. Short-term interferon-alfa therapy for acute hepatitis C: a randomized controlled trial. Hepatology. 2004 May;39(5):1213-9.
Kamal SM, Rasenack JW, Bianchi L, Al Tawil A, El Sayed Khalifa K, Peter T, Mansour H, Ezzat W, Koziel M. Acute hepatitis C without and with schistosomiasis: correlation with hepatitis C-specific CD4(+) T-cell and cytokine response. Gastroenterology. 2001 Sep;121(3):646-56.
Santantonio T, Sinisi E, Guastadisegni A, Casalino C, Mazzola M, Gentile A, Leandro G, Pastore G. Natural course of acute hepatitis C: a long-term prospective study. Dig Liver Dis. 2003 Feb;35(2):104-13.
Wiegand J, Jackel E, Cornberg M, Hinrichsen H, Dietrich M, Kroeger J, Fritsch WP, Kubitschke A, Aslan N, Tillmann HL, Manns MP, Wedemeyer H. Long-term follow-up after successful interferon therapy of acute hepatitis C. Hepatology. 2004 Jul;40(1):98-107.
Kamal SM, El Tawil AA, Nakano T, He Q, Rasenack J, Hakam SA, Saleh WA, Ismail A, Aziz AA, Madwar MA. Peginterferon {alpha}-2b and ribavirin therapy in chronic hepatitis C genotype 4: impact of treatment duration and viral kinetics on sustained virological response. Gut. 2005 Jun;54(6):858-66.
Jaeckel E, Cornberg M, Wedemeyer H, Santantonio T, Mayer J, Zankel M, Pastore G, Dietrich M, Trautwein C, Manns MP; German Acute Hepatitis C Therapy Group. Treatment of acute hepatitis C with interferon alfa-2b. N Engl J Med. 2001 Nov 15;345(20):1452-7.
Larghi A, Zuin M, Crosignani A, Ribero ML, Pipia C, Battezzati PM, Binelli G, Donato F, Zanetti AR, Podda M, Tagger A. Outcome of an outbreak of acute hepatitis C among healthy volunteers participating in pharmacokinetics studies. Hepatology. 2002 Oct;36(4 Pt 1):993-1000.

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

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

Study placed in the following topic categories:
Interferon-alpha
Anti-Infective Agents
Liver Diseases
Immunologic Factors
Ribavirin
Interferons
Hepatitis, Viral, Human
Antiviral Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Interferon Alfa-2a

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009