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Pegylated Interferon Alfa-2b Plus Ribavirin in Chronic Hepatitis B and Delta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00117533
Recruitment Status : Unknown
Verified September 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 7, 2005
Last Update Posted : May 25, 2006
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Brief Summary:
The treatment of choice for chronic hepatitis D is uncertain. The investigators hypothesize that pegylated interferon (IFN) alfa-2b in combination with ribavirin (RBV) may be effective in the treatment of chronic hepatitis D patients who are also infected by hepatitis B virus (HBV). The purpose of this study is to test this hypothesis. The investigators will use pegylated IFN alfa-2b in combination with RBV for the treatment of patients with dual chronic hepatitis D virus (HDV) and HBV infection. A 24-week course of combination therapy pegylated IFN+RBV will be used.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Chronic Hepatitis D Drug: pegylated IFN alfa-2b plus ribavirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Efficacy and Safety of Pegylated Interferon Alfa-2b Plus Ribavirin in the Treatment of Patients With Dual Chronic Hepatitis B and Delta
Study Start Date : September 2005
Study Completion Date : June 2007

Primary Outcome Measures :
  1. the efficacy of 24-week pegylated IFN alfa-2b plus RBV for SVR of HDV in patients with dual chronic hepatitis D and B

Secondary Outcome Measures :
  1. the efficacy of pegylated IFN alfa-2b plus RBV in patients with dual chronic hepatitis D and B on: The biochemical response rate
  2. The degree of histologic change

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be positive for both anti-HDV and HBsAg for more than 6 months
  • Present with elevated serum ALT levels at least 1.5 times the upper limit of normal, documented on two occasions (at least one month apart), within six months prior to enrollment
  • Be HDV RNA positive by PCR (sensitivity: 103 copies/mL) [Yamashiro et al, 2004]
  • Be HBV DNA positive by PCR
  • Present with liver biopsy findings compatible with the diagnosis of chronic liver disease (the liver biopsy needs to be taken within 52 weeks prior to enrollment)
  • Have adequate liver reserve (defined as equal to or better than Child-Pugh Class A)
  • Present with WBC ≥3000/mm3, ANC ≥1500/mm3, and platelet ≥80,000/mm3
  • Be able to and likely to attend regularly for treatment and follow-up
  • Give their written informed consent
  • Be negative for urine pregnancy test (for females of childbearing potential), documented once within the screening period and again within 24 hours prior to the first dose of study drug
  • All male patients with female partners of childbearing age should use a barrier method of contraception
  • All female patients of childbearing potential must use two reliable forms of effective contraception

Exclusion Criteria:

  • Drug addicts or have any history or histological evidence of alcohol abuse, or currently receive prescriptions that may cause hepatotoxicity
  • Have decompensated cirrhosis as coded by Child-Pugh classification (i.e. history of ascites, history of bleeding from esophageal varices, severe portal hypertension, serum albumin <30 g/l, serum bilirubin >30 mg/l)
  • Present with WBC <3000/mm3, ANC <1500/mm3, or platelets <90,000/mm3
  • Present with hemoglobin <12.0 gm/dl for female and <13.0 gm/dl for male
  • Have been treated with immunosuppressive therapy within the past six months (e.g. steroids, azathioprine, cyclophosphamide)
  • Have renal insufficiency (serum creatinine >150 μmol/l)
  • Have clotting abnormalities which preclude a liver biopsy
  • Have evidence of any serious neurological dysfunction
  • Have obesity or diabetes mellitus-induced liver disease
  • Have serological evidence of autoimmune chronic liver disease (e.g. antinuclear antibody titers >1:320, and/or smooth muscle antibody titers>1:160)
  • Hemophiliacs
  • Have evidence of inheritable disorders such as haemochromatosis, alpha-1-antitrypsin deficiency or Wilson's disease
  • Have been exposed to hepatotoxic substances which might be the cause of hepatitis
  • Pregnant, lactating or not practicing an adequate form of birth control, such as oral contraceptives or intrauterine devices
  • Seropositive for anti-HIV or anti-HCV
  • Have serious psychological or psychiatric problems disrupting daily activities
  • Have AFP (alpha-fetoprotein) greater than 20 ng/ml; in case of elevated AFP, abdomen ultrasonography is required to exclude the possibility of HCC
  • Have serious heart diseases (coronary heart disease, etc)
  • Have a history of asthma or drug allergy which may lead to hypersensitivity to ribavirin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00117533

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Contact: Pei-Jer Chen, M.D., Ph.D. 886-2-23123456 ext 7072

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
National Taiwan University Not yet recruiting
Taipei, Taiwan, 100
Contact: Pei-Jer Chen, M.D.; Ph.D.    886-2-23123456 ext 7072   
Principal Investigator: Pei-Jer Chen, M.D., Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
National Science Council, Taiwan
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Principal Investigator: Pei-Jer Chen, M.D., Ph.D. National Taiwan University Hospital
Layout table for additonal information Identifier: NCT00117533    
Other Study ID Numbers: 930904
First Posted: July 7, 2005    Key Record Dates
Last Update Posted: May 25, 2006
Last Verified: September 2005
Keywords provided by National Taiwan University Hospital:
chronic hepatitis B;
chronic hepatitis delta;
pegylated interferon alfa-2b;
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis D
Hepatitis D, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon alpha-2
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents