Timing and Duration of Acute Hepatitis C Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis C

Keywords

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Clinical trial Randomized Treatment Prospective Parallel Assignment Efficacy Safety Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pegylated interferon alpha 2

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Alaa Ismail, M.D.

Role: STUDY_CHAIR

Ain Shams University

Sanaa M Kamal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Nezam H Afdhal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Manal El Sayed, M.D.

Role: PRINCIPAL_INVESTIGATOR

ASU

Locations

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ASU Specialized Hospital

Cairo, Cairo Governorate, Egypt

Site Status

ASU

Cairo, , Egypt

Site Status

Shebin Liver Center

Cairo, , Egypt

Site Status

Countries

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Germany United States Egypt

References

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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. doi: 10.1002/hep.20266.

Reference Type BACKGROUND

PMID: 15185314 (View on PubMed)

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. doi: 10.1016/s0016-5085(03)00668-1.

Reference Type BACKGROUND

PMID: 12851873 (View on PubMed)

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. doi: 10.1002/hep.20196.

Reference Type BACKGROUND

PMID: 15122749 (View on PubMed)

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. doi: 10.1053/gast.2001.27024.

Reference Type BACKGROUND

PMID: 11522749 (View on PubMed)

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. doi: 10.1016/s1590-8658(03)00007-0.

Reference Type BACKGROUND

PMID: 12747629 (View on PubMed)

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. doi: 10.1002/hep.20291.

Reference Type BACKGROUND

PMID: 15239091 (View on PubMed)

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. doi: 10.1136/gut.2004.057182.

Reference Type BACKGROUND

PMID: 15888797 (View on PubMed)

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. doi: 10.1056/NEJMoa011232.

Reference Type BACKGROUND

PMID: 11794193 (View on PubMed)

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. doi: 10.1053/jhep.2002.36129.

Reference Type BACKGROUND

PMID: 12297849 (View on PubMed)