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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00117533
First received: June 30, 2005
Last updated: May 24, 2006
Last verified: September 2005
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00117533     History of Changes
Other Study ID Numbers: 930904
Study First Received: June 30, 2005
Last Updated: May 24, 2006
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

Additional relevant MeSH terms:
Hepatitis D, Chronic
Hepatitis D
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon-alpha
Interferons
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014