Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 20, 2004
Last Updated Date	January 23, 2008
Start Date ^†	December 2003
Current Primary Outcome Measures ^† (submitted: December 27, 2007)	Primary Outcome is a composite endpoint termed Clinical Response, defined as achievement of the following three efficacy criteria: Serum HBV DNA < 4 log10 copies/mL, Normal ALT level, Improvement or stabilization in CTP score [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00076336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: December 27, 2007)	Time to Clinical Response; Duration of Clinical Response; Improvement, Stabilization, and Worsening in CTP score; Improvement, Stabilization, and Worsening in a modified (3-component) CTP score [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Official Title ^†	Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Brief Summary	This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Hepatitis Hepatitis B, Chronic Cirrhosis
Intervention ^†	Drug: telbivudine Drug: lamivudine
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 ^†	Active, not recruiting
Enrollment ^†	232
Completion Date
Estimated Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: Documented decompensated chronic hepatitis B defined by all of the following: 1. Clinical history compatible with decompensated chronic hepatitis B related cirrhosis; 2. Child-Turcotte-Pugh score > 7 points. Evidence of hepatic cirrhosis or portal hypertension. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding. Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV. Patient previously received lamivudine, adefovir, or an investigational anti-HBV nucleoside or nucleotide analog at any time Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before Screening for this study. Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	16 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Australia, Canada, China, France, Germany, India, Israel, Korea, Republic of, Latvia, Malaysia, New Zealand, Poland, Russian Federation, Singapore, Spain, Taiwan, Thailand, Turkey, United Kingdom, Vietnam
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00076336
Responsible Party	Novartis
Secondary IDs ^††
Study Sponsor ^†	Novartis
Collaborators ^††
Investigators ^†
Information Provided By	Novartis
Verification Date	January 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.