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

NCT00117533 | Unknown Phase 4

• 1 other identifier: 930904
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Hepatitis B; Chronic Hepatitis D

Keywords

chronic hepatitis B;; chronic hepatitis delta;; treatment;; pegylated interferon alfa-2b;; ribavirin

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

Interventions

pegylated IFN alfa-2b plus ribavirin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator
• National Science and Technology Council, Taiwan: collaborator

Study Sites (2)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

National Taiwan University

Taipei, Taipei, 100, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis D, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis D; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Pei-Jer Chen, M.D., Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Jer Chen, M.D., Ph.D.

CONTACT

886-2-23123456; peijer@ha.mc.ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 7, 2005
• Study Start: September 1, 2005
• Study Completion: June 1, 2007
• Last Updated: May 25, 2006

Record last verified: 2005-09

Locations

TW (2)