Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

This study has been completed.

Study NCT00412529 Information provided by Novartis

First Received on December 15, 2006. Last Updated on July 18, 2011 History of Changes

Results First Received: December 2, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Hepatitis B Chronic Hepatitis B
Interventions:	Drug: Entecavir Drug: Telbivudine

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Telbivudine	Telbivudine 600 mg once daily for 12 weeks.
Entecavir	Entecavir 0.5 mg once daily for 12 weeks.

Participant Flow: Overall Study

	Telbivudine	Entecavir
STARTED	23	21
COMPLETED	23	21
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Telbivudine	Telbivudine 600 mg once daily for 12 weeks.
Entecavir	Entecavir 0.5 mg once daily for 12 weeks.

Baseline Measures

	Telbivudine	Entecavir	Total
Number of Participants [units: participants]	23	21	44
Age ^[1] [units: Years] Mean ± Standard Deviation	36.2 ± 9.62	33.4 ± 8.82	34.9 ± 9.25
Gender [units: Participants]
Female	5	9	14
Male	18	12	30

[1]	Baseline Measures based on Intention to treat population.

Outcome Measures

Show All Outcome Measures

1. Primary:

Change in Mean Hepatitis B Virus (HBV) DNA Levels [ Time Frame: Baseline (day 1) to Week 12 (day 85) ]

Show Outcome Measure 1

2. Secondary:

Change in Mean HBV DNA Level [ Time Frame: Baseline (day 1) to Weeks 2, 4, 8 ]

Show Outcome Measure 2

3. Secondary:

The Area Under the Curve (AUC) of HBV DNA Change. [ Time Frame: From Baseline to Week 12 ]

Show Outcome Measure 3

4. Secondary:

Change in Alanine Aminotransferase (ALT) Levels [ Time Frame: From Baseline to Week 12 ]

Show Outcome Measure 4

5. Secondary:

Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance [ Time Frame: Baseline to 12 weeks ]

Show Outcome Measure 5

6. Secondary:

Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss [ Time Frame: Baseline to 12 weeks ]

Show Outcome Measure 6

7. Secondary:

Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production [ Time Frame: Baseline to 12 weeks ]

Show Outcome Measure 7

8. Secondary:

Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative [ Time Frame: At Week 12 ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

Results Point of Contact:

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

Publications of Results:

Suh DJ, Um SH, Herrmann E, Kim JH, Lee YS, Lee HJ, Lee MS, Lee YJ, Bao W, Lopez P, Lee HC, Avila C, Zeuzem S. Early viral kinetics of telbivudine and entecavir: results of a 12-week randomized exploratory study with patients with HBeAg-positive chronic hepatitis B. Antimicrob Agents Chemother. 2010 Mar;54(3):1242-7. Epub 2009 Dec 22.

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00412529 History of Changes
Other Study ID Numbers:	CLDT600A2407
Study First Received:	December 15, 2006
Results First Received:	December 2, 2010
Last Updated:	July 18, 2011
Health Authority:	Korea: Food and Drug Administration; United States: Food and Drug Administration