Full Text View
Tabular View
No Study Results Posted
Related Studies
Peg-Intron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (Study P04498)(COMPLETED)
This study has been completed.
Study NCT00371761   Information provided by Schering-Plough
First Received: August 31, 2006   Last Updated: May 13, 2009   History of Changes

August 31, 2006
May 13, 2009
March 2006
March 2009   (final data collection date for primary outcome measure)
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) [ Time Frame: At Week 72 (for Group A, at 48 weeks post Peg-Intron treatment for up to 24 weeks; for Group B, at 24 weeks post adefovir treatment for up to 48 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00371761 on ClinicalTrials.gov Archive Site
(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 [ Time Frame: (a) At the end of treatment (Group A at 24 weeks, Group B at 48 week); (b) At the end of treatment and at Week 72; (c) At Week 72 ] [ Designated as safety issue: No ]
(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 [ Time Frame: (a) At the end of treatment (Group A at 24 weeks, Group B at 48 week); (b) At the end of treatment and at Week 72; (c) At Week 72 ] [ Designated as safety issue: No ]
 
Peg-Intron 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 Peg-Intron 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 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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Hepatitis B, Chronic
  • Drug: Pegylated interferon alfa-2b
  • Drug: Adefovir dipivoxil
  • Experimental: Peg-Intron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
  • Active Comparator: Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
160
March 2009
March 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 >= 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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00371761
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
P04498
Schering-Plough
 
 
Schering-Plough
May 2009

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