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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA < 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT = Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.
Timepoint [1] 0 0
From Baseline to Week 52
Secondary outcome [1] 0 0
Time to Initial Clinical Response - Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response.
Timepoint [1] 0 0
From Baseline to Week 104
Secondary outcome [2] 0 0
Duration of Initial Clinical Response - Kaplan-Meier method was used. The duration was calculated as: date of last visit before initial loss of clinical response - date of initial clinical response occurred+1. If a patient did not lose clinical response, it was then censored at the efficacy overall censoring date.
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 - Child-Turcotte-Pugh (CTP) uses 2 clinical variables, ascites and encephalopathy, and 3 laboratory parameters, serum bilirubin, albumin, and prothrombin time. Each variable is assigned a score from 1 to 3, with the combined score comprising the CTP score range of 5 to 15 points. Higher scores indicate more impaired liver function. "Worsening" of CTP score was defined as a 2-point or greater increase from baseline, "improvement" in CTP score was defined as a 2-point or greater reduction from baseline, and "stabilization" of CTP score was defined as a change of 1-point or less from baseline.
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 - Modified CTP was calculated using the 3 biochemical-components (serum bilirubin, albumin, and prothrombin). Total scores range from 3-9; higher scores indicate more liver impairment. Improvement was defined as 2-point or greater reduction in score from baseline. Stabilization comprises a score change of 1-point or less from baseline. Worsening of CTP score was defined as a 2-point or greater increase from baseline. The rationale for assessing changes in this modified (3-component) CTP score is that this maneuver removed the two subjective components of CTP scoring (ascites and encephalopathy).
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
This research study was 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.
Trial website
https://clinicaltrials.gov/show/NCT00076336
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

Summary results
Other publications