PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (Study P04498)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00371761
First received: August 31, 2006
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Hepatitis B, Chronic (CHB)
Drug: Pegylated interferon alfa-2b (PegIntron)
Drug: Adefovir dipivoxil (adefovir)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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] ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: September 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PegIntron
PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00371761     History of Changes
Other Study ID Numbers: P04498
Study First Received: August 31, 2006
Results First Received: July 15, 2010
Last Updated: November 18, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Schering-Plough:
Hepatitis B virus
Pegylated interferon alfa-2b (PegIntron)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Adefovir
Adefovir dipivoxil
Interferon-alpha
Interferons
Peginterferon alfa-2b
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014