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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00371761

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 III

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Interferon alfa-2a Interferon alfa-2b Adefovir Adefovir dipivoxil Peginterferon Alfa-2b Interferon alfa-n1 Recombinant hepatitis B vaccine Hepatitis B Vaccines Hepatitis A Vaccines Interferons

U.S. FDA Resources

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

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, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon-alpha

Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Adefovir dipivoxil
Adefovir
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012