Status:
UNKNOWN
Pegylated Interferon Alfa-2b Plus Ribavirin in Chronic Hepatitis B and Delta
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Health Research Institutes, Taiwan
National Science and Technology Council, Taiwan
Conditions:
Chronic Hepatitis B
Chronic Hepatitis D
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 treatmen...
Detailed Description
Recombinant IFN alfa possesses anti-viral and immunomodulatory effects and has been shown to be effective in chronic hepatitis B \[Davis et al. 1989; Bisceclie et al, 1989\]. Interferon alfa is also o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00117533
Start Date
September 1 2005
End Date
June 1 2007
Last Update
May 25 2006
Active Locations (2)
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1
National Taiwan University Hospital
Taipei, Taipei, Taiwan, 100
2
National Taiwan University
Taipei, Taipei, Taiwan, 100