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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371761
Recruitment Status : Completed
First Posted : September 4, 2006
Results First Posted : December 15, 2010
Last Update Posted : April 6, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic (CHB) Biological: Pegylated interferon alfa-2b (PegIntron) Drug: Adefovir dipivoxil (adefovir) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Comparative Study With PegIntron vs. Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan
Study Start Date : September 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: PegIntron
PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
Biological: 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
Other Name: SCH 54031, Peg-Intron

Active Comparator: Adefovir
Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
Drug: 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
Other Name: Hepsera

Primary Outcome Measures :
  1. Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response [ Time Frame: At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 weeks] ]
    1. Serological response is defined as Loss of HBeAg (Hepatitis B e antigen) and Appearance of anti-HBe (Hepatitis B e antibodies); participant is HBeAg negative and anti-HBe positive.
    2. Virological response was defined as having < 10^5 copies/mL of serum HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) by real-time PCR (Polymerase Chain Reaction).
    3. Biochemical response was defined as acheiving normal levels of ALT (Alanine Aminotransferase) level in Units/L.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00371761     History of Changes
Other Study ID Numbers: P04498
First Posted: September 4, 2006    Key Record Dates
Results First Posted: December 15, 2010
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatitis B virus
Pegylated interferon alfa-2b (PegIntron)
Additional relevant MeSH terms:
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Interferon alpha-2
Peginterferon alfa-2b
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Adefovir dipivoxil
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents