Peg-Intron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (Study P04498)(COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	August 31, 2006
Last Updated Date	May 13, 2009
Start Date ^ICMJE	March 2006
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00371761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 29, 2008)	(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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: December 20, 2007)	(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 ]

Descriptive Information
Brief Title ^ICMJE	Peg-Intron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (Study P04498)(COMPLETED)
Official Title ^ICMJE	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
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 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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Hepatitis B, Chronic
Intervention ^ICMJE	Drug: Pegylated interferon alfa-2b Drug: Adefovir dipivoxil
Study Arms / Comparison Groups	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
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	160
Completion Date	March 2009
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00371761
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	P04498
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP