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

• Status: Unknown status
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborators: National Health Research Institutes, Taiwan; National Science Council, Taiwan
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

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