Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B - Tabular View

Tracking Information
First Received Date ^ICMJE	November 12, 2002
Last Updated Date	August 11, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00048945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B
Official Title ^ICMJE
Brief Summary	The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Chronic Hepatitis B
Intervention ^ICMJE	Drug: PEGASYS
Study Arms / Comparison Groups
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
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Clinical diagnosis of hepatitis B Not pregnant Exclusion Criteria: Treatment for hepatitis B in past 6 months Other hepatitis infections Severe liver disease Pregnancy
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Brazil, Canada, China, France, Germany, Israel, Korea, Republic of, New Zealand, Poland, Puerto Rico, Singapore, Switzerland, Taiwan, Thailand, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00048945
Responsible Party
Study ID Numbers ^ICMJE	WV16240
Study Sponsor ^ICMJE	Hoffmann-La Roche
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Hoffmann-La Roche
Verification Date	August 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP