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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 31, 2006
Last Updated Date	November 18, 2010
Start Date ^ICMJE	September 2006
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 18, 2010)	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 ] 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. 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). Biochemical response was defined as acheiving normal levels of ALT (Alanine Aminotransferase) level in Units/L.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00371761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PegIntron 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 PegIntron 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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hepatitis B, Chronic (CHB)
Intervention ^ICMJE	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
Study Arm (s)	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date	February 2009
Primary Completion Date	February 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 (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.
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	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00371761
Other Study ID Numbers ^ICMJE	P04498
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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