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Pegylated Interferon Alfa-2b Plus Ribavirin in Chronic Hepatitis B and Delta
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, September 2005
Sponsors and Collaborators: National Taiwan University Hospital
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00117533
  Purpose

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 Intervention Phase
Chronic Hepatitis B
Chronic Hepatitis D
Drug: pegylated IFN alfa-2b plus ribavirin
Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Ribavirin Hepatitis B Vaccines Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 20
Study Start Date: September 2005
Estimated Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117533

Contacts
Contact: Pei-Jer Chen, M.D., Ph.D. 886-2-23123456 ext 7072 peijer@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Not yet recruiting
Taipei, Taiwan, 100
Contact: Pei-Jer Chen, M.D.; Ph.D.     886-2-23123456 ext 7072     peijer@ha.mc.ntu.edu.tw    
Principal Investigator: Pei-Jer Chen, M.D., Ph.D.            
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Investigators
Principal Investigator: Pei-Jer Chen, M.D., Ph.D. National Taiwan University Hospital
  More Information

Study ID Numbers: 930904
Study First Received: June 30, 2005
Last Updated: May 24, 2006
ClinicalTrials.gov Identifier: NCT00117533  
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
chronic hepatitis B;
chronic hepatitis delta;
treatment;
pegylated interferon alfa-2b;
ribavirin

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis D, Chronic
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis B, Chronic
Peginterferon alfa-2b
Hepatitis B
Hepatitis D
DNA Virus Infections
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hepadnaviridae Infections
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009