Peg-Intron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (Study P04498)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B, Chronic
Intervention: Pegylated interferon alfa-2b (Drug); Adefovir dipivoxil (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Schering-Plough Official(s) and/or principal investigator(s):
Ding-Shinn Chen, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Summary
This is an open label, randomized, comparative, multi-center study. Subjects will be
screened within 2 weeks prior to study entry to establish eligibility. Subjects who meet all
the selection criteria will be randomly assigned 1: 1 to (1) once-a-week, subcutaneous
Peg-Intron (1. 5 mg/kg body weight) or (2) oral adefovir 10 mg daily. The treatment phase
will be 24 weeks for Peg-Intron and 48 weeks for adefovir. All subjects completing the
assigned treatment phase will be followed up for an additional 48 weeks for Peg-Intron and 24
weeks for adefovir as observation phase. The primary objective is to establish the efficacy
profile of Peg-Intron. Secondary objectives are to compare the efficacy profile of
Peg-Intron with that of adefovir, compare efficacy of Peg-Intron in lamivudine-naïve and
lamivudine-experienced subjects, and to establish the safety profile of Peg-Intron in
treating patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.
Clinical Details
Official title: An Open-Label, Randomized, Comparative Study With Peg-Intron vs. Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Combined response consisting of
(a) serological response (loss of HBeAg and appearance of anti-HBe),
(b) virological response (HBV DNA <105 copies/mL by real-time PCR),
(c) biochemical response (normalization of serum ALT level)
Secondary outcome: (a) Combined response;
(b) The rates of
• serologic response,
• serum HBV DNA <105 copies/mL,
• HBeAg loss,
• ALT normalization,
• HBsAg loss;
(c) The rate of histologic response
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult male or female, 18 to 70 years of age.
- Documented positive serum hepatitis B surface antigen (HBsAg) for a minimum of 6
months prior to randomization.
- Hepatitis B virus (HBV) replication and hepatitis documented by:
- Serum HBV DNA >= 105 copies/mL within 3 months prior to entry
- Positive serum hepatitis B e antigen (HBeAg) within 3 months prior to entry
- Documented presence of ALT twice (1 month apart) within 3 months prior to entry
(2 to 10 folds above the upper normal level)
- Liver biopsy finding shows evidence of chronic hepatitis without liver cirrhosis,
document acceptable if no anti-HBV treatment within 1 year prior to
randomization
- Naïve or exposed to lamivudine (3 months treatment-free interval prior to
randomization)
- Adequate renal function (creatinine within normal upper limit).
- Compensated liver disease with certain minimum hematological and serum biochemical
criteria.
- Thyroid stimulating hormone (TSH) and free T4 within normal ranges.
- Negative antibody to hepatitis C and hepatitis D.
- Negative antibody to human immunodeficiency virus.
- Negative evidence for hepatocellular carcinoma by alfa-fetoprotein and ultrasound
within 1 month prior to randomization.
Exclusion Criteria:
- Women who are pregnant or nursing.
- Prior treatment for hepatitis with any interferon or adefovir, or other
investigational anti-virus agents.
- Prior treatment for hepatitis with immunomodulatory drug within 2 years prior to
randomization.
- Suspected hypersensitivity to interferon or adefovir.
- Liver cirrhosis.
- History of severe psychiatric disease, especially depression.
- Concurrent malignancies (including hepatocellular carcinoma).
- Unstable or significant cardiovascular diseases.
- Prolonged exposure to known hepatotoxins.
- History of thyroid disease poorly controlled on prescribed medication.
- Poorly controlled diabetes mellitus.
- Have suspected or confirmed significant hepatic disease from an etiology other than
HBV.
- Severe renal disease or myeloid dysfunction.
- History of organ transplantation other than cornea and hair transplant.
- Any medical condition requiring chronic systemic administration of steroids.
Locations and Contacts
Investigational Site 1, Taipei 100, Taiwan
Investigational Site 2, Taipei 114, Taiwan
Investigational Site 3, Taiwan 333, Taiwan
Investigational Site 4, Changhua 500, Taiwan
Investigational Site 5, Taichung 404, Taiwan
Investigational Site 6, Tainan 704, Taiwan
Additional Information
Starting date: March 2006
Ending date: March 2009
Last updated: June 16, 2008
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