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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00076336




Registration number
NCT00076336
Ethics application status
Date submitted
20/01/2004
Date registered
22/01/2004
Date last updated
5/09/2011

Titles & IDs
Public title
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Scientific title
Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Secondary ID [1] 0 0
CLDT600A2301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis 0 0
Hepatitis B, Chronic 0 0
Cirrhosis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Telbivudine
Treatment: Drugs - Lamivudine
Treatment: Drugs - Placebo

Experimental: Telbivudine 600 mg - Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.

Active comparator: Lamivudine 100 mg - Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.


Treatment: Drugs: Telbivudine
600mg/day oral tablet for 104 weeks

Treatment: Drugs: Lamivudine
100mg/day oral tablet for 104 weeks

Treatment: Drugs: Placebo
Telbivudine matching placebo or lamivudine matching placebo tablet.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Response
Timepoint [1] 0 0
From Baseline to Week 52
Secondary outcome [1] 0 0
Time to Initial Clinical Response
Timepoint [1] 0 0
From Baseline to Week 104
Secondary outcome [2] 0 0
Duration of Initial Clinical Response
Timepoint [2] 0 0
Baseline to Week 104
Secondary outcome [3] 0 0
Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104
Timepoint [3] 0 0
From Baseline to weeks 52 and 104
Secondary outcome [4] 0 0
Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score
Timepoint [4] 0 0
Baseline and Week 104

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient is pregnant or breastfeeding.
* Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV).
* Patient previously received lamivudine, adefovir, or an investigational anti-hepatitis B virus (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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
232
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Heidelburg
Recruitment postcode(s) [1] 0 0
- Heidelburg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Canada
State/province [9] 0 0
Winnipeg
Country [10] 0 0
China
State/province [10] 0 0
Hong Kong
Country [11] 0 0
France
State/province [11] 0 0
Villejuif Cedex
Country [12] 0 0
Germany
State/province [12] 0 0
Hannover
Country [13] 0 0
India
State/province [13] 0 0
New Delhi
Country [14] 0 0
Israel
State/province [14] 0 0
Tel Aviv
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Latvia
State/province [16] 0 0
Riga
Country [17] 0 0
Malaysia
State/province [17] 0 0
Kuala Lumpur
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland
Country [19] 0 0
Poland
State/province [19] 0 0
Krakow
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Moscow
Country [21] 0 0
Singapore
State/province [21] 0 0
Singapore
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taipei
Country [24] 0 0
Thailand
State/province [24] 0 0
Bangkok
Country [25] 0 0
Turkey
State/province [25] 0 0
Istanbul
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London
Country [27] 0 0
Vietnam
State/province [27] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal E.J. Gane, H.L. Chan, G. Choudhuri, D.J. Suh4, A. ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00076336