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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

August 31, 2006
November 18, 2010
September 2006
February 2009   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00371761 on ClinicalTrials.gov Archive Site
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PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (Study P04498)(COMPLETED)
An Open-Label, Randomized, Comparative Study With PegIntron vs. Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic (CHB)
  • 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
  • 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
  • Experimental: PegIntron
    PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
    Intervention: Drug: Pegylated interferon alfa-2b (PegIntron)
  • Active Comparator: Adefovir
    Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
    Intervention: Drug: Adefovir dipivoxil (adefovir)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00371761
P04498
No
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Schering-Plough
Not Provided
Not Provided
Schering-Plough
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP