PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)

NCT ID: NCT00371761

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-02-28

Brief 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 Pegylated interferon alfa-2b (PegIntron) (1.5 mcg/kg body weight) or (2) oral adefovir 10 mg daily. The treatment phase will be 24 weeks for PegIntron and 48 weeks for adefovir. All subjects completing the assigned treatment phase will be followed up for an additional 48 weeks for PegIntron and 24 weeks for adefovir as observation phase. The primary objective is to establish the efficacy profile of PegIntron. Secondary objectives are to compare the efficacy profile of PegIntron with that of adefovir, compare efficacy of PegIntron in lamivudine-naïve and lamivudine-experienced subjects, and to establish the safety profile of PegIntron in treating patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.

Conditions

Hepatitis B, Chronic (CHB)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PegIntron

PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase

Group Type: EXPERIMENTAL

Pegylated interferon alfa-2b (PegIntron)

Intervention Type: BIOLOGICAL

Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks

Adefovir

Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase

Group Type: ACTIVE_COMPARATOR

Adefovir dipivoxil (adefovir)

Intervention Type: DRUG

10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks

Interventions

Pegylated interferon alfa-2b (PegIntron)

Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks

Intervention Type: BIOLOGICAL

Adefovir dipivoxil (adefovir)

10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks

Intervention Type: DRUG

Other Intervention Names

SCH 54031, Peg-Intron; Hepsera

Eligibility 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 (Hepatitis B Virus Deoxyribonucleic acid) >= 10^5 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 (Alanine Aminotransferase) 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04498

Identifier Type: -

Identifier Source: org_study_id