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

This study has been completed.

Study NCT00076336 Information provided by Novartis

First Received on January 20, 2004. Last Updated on August 4, 2011 History of Changes

Results First Received: January 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Hepatitis Hepatitis B, Chronic Cirrhosis
Interventions:	Drug: Telbivudine Drug: Lamivudine Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
232 patients randomized. One randomized patient in the telbivudine treatment group discontinued prior to commencing treatment and was excluded from the intent to treat (ITT) population. Three randomized patients (two in lamivudine group and one in telbivudine group) had no HBV DNA assessments after baseline and were excluded from ITT population.

Reporting Groups

	Description
Telbivudine 600 mg	Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Lamivudine 100 mg	Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.

Participant Flow: Overall Study

	Telbivudine 600 mg	Lamivudine 100 mg
STARTED	116	116
Safety Population	115 ^[1]	116
Intent to Treat (ITT) Population	114 ^[2]	114 ^[3]
Completed Week 52	97	94
Completed Week 104	70	62
COMPLETED	64	60
NOT COMPLETED	52	56
Death	13	17
Adverse Event	4	4
Lost to Follow-up	4	4
Non-Compliance	2	0
Creatinine Clearance < 30 or Dialysis	0	1
Patient, Investigator, Sponsor request	8	6
Liver Transplantation	3	3
Virologic Breakthrough	14	16
Treatment failure	4	5

[1]	1 patient was randomized but never received study drug and not included in safety population.
[2]	1 patient had no HBV DNA assessments after baseline and was excluded from ITT population.
[3]	2 patients had no HBV DNA assessments after baseline and were excluded from ITT population.

Baseline Characteristics

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Reporting Groups

	Description
Telbivudine 600 mg	Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Lamivudine 100 mg	Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.

Baseline Measures

	Telbivudine 600 mg	Lamivudine 100 mg	Total
Number of Participants [units: participants]	114	114	228
Age ^[1] [units: years] Mean ± Standard Deviation	49.6 ± 10.88	51.9 ± 9.98	50.8 ± 10.48
Age, Customized [units: Participants]
< 30 years	6	2	8
Between 30 and 50 years	44	44	88
> 50 years	64	68	132
Gender [units: participants]
Female	27	33	60
Male	87	81	168

[1]	Baseline measures are based on intention to treat (ITT) population.

Outcome Measures

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1. Primary:

Number of Participants With Clinical Response [ Time Frame: From Baseline to Week 52 ]

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2. Secondary:

Time to Initial Clinical Response [ Time Frame: From Baseline to Week 104 ]

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3. Secondary:

Duration of Initial Clinical Response [ Time Frame: Baseline to Week 104 ]

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4. Secondary:

Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104 [ Time Frame: From Baseline to weeks 52 and 104 ]

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5. Secondary:

Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score [ Time Frame: Baseline and Week 104 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00076336 History of Changes
Other Study ID Numbers:	CLDT600A2301
Study First Received:	January 20, 2004
Results First Received:	January 3, 2011
Last Updated:	August 4, 2011
Health Authority:	United States: Food and Drug Administration