Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis

This study has been completed.

Study NCT00347009 Information provided by GlaxoSmithKline

First Received on June 30, 2006. Last Updated on March 17, 2011 History of Changes

Results First Received: September 20, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Hepatitis B, Chronic Cirrhosis Fibrosis Chronic Hepatitis B
Intervention:	Drug: adefovir dipivoxil

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
Adefovir Dipivoxil 10 Milligrams (mg)	Adefovir Dipivoxil 10 mg, once daily

Participant Flow: Overall Study

	Adefovir Dipivoxil 10 Milligrams (mg)
STARTED	155
COMPLETED	128
NOT COMPLETED	27
Death	1
Adverse Event	6
Withdrawal by Subject	3
Physician Decision	5
Lost to Follow-up	4
Protocol Violation	2
Adverse Laboratory Experience	1
Insufficient Viral Suppression	3
Increased ALT/HBV DNA	1
Serious Adverse Event	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Adefovir Dipivoxil 10 Milligrams (mg)	Adefovir Dipivoxil 10 mg, once daily

Baseline Measures

	Adefovir Dipivoxil 10 Milligrams (mg)
Number of Participants [units: participants]	155
Age [units: Years] Mean ± Standard Deviation	47.7 ± 9.5
Gender [units: Participants]
Female	39
Male	116
Race/Ethnicity, Customized [units: participants]
Asian	155
Other	0
Time since Diagnosis of Chronic Hepatitis B ^[1] [units: years] Mean ± Standard Deviation	11.29 ± 8.40

[1]	Diagnosis of chronic hepatitis B is defined by the presence of serum hepatitis B surface antigen (HBsAg) for at least 6 months (once at least 6 months before screening and at time of screening visit).

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants With Histologic Improvement at Month 36 (Intent-to-Treat Population) [ Time Frame: Screening and Month 36 ]

Show Outcome Measure 1

2. Primary:

Number of Participants With Histologic Improvement at Month 36 (Per Protocol Population) [ Time Frame: Screening and Month 36 ]

Show Outcome Measure 2

3. Secondary:

Number of Participants With a Reduction From Baseline in the Child-Pugh Score by 2 Points or More at Months 12, 24, and 36 [ Time Frame: Baseline and Months 12, 24, and 36 ]

Show Outcome Measure 3

4. Secondary:

Number of Participants With a Reduction From Screening of at Least 2 Points in the Knodell Necroinflammation Score at Month 36 [ Time Frame: Screening and Month 36 ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline in Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level at Months 12, 24, and 36 [ Time Frame: Baseline and Months 12, 24, and 36 ]

Show Outcome Measure 5

6. Secondary:

Number of Participants Achieving Virological Response (HBV DNA Level <= 10^3 Copies/ml) at Months 12, 24, and 36 [ Time Frame: Months 12, 24, and 36 ]

Show Outcome Measure 6

7. Secondary:

Number of Participants Achieving Virological Response (HBV DNA Level <= 10^4 Copies/ml) at Months 12, 24, and 36 [ Time Frame: Months 12, 24, and 36 ]

Show Outcome Measure 7

8. Secondary:

Number of Participants With Undetectable HBV DNA at Months 12, 24, and 36 [ Time Frame: Months 12, 24, and 36 ]

Show Outcome Measure 8

9. Secondary:

Number of Participants With Virological Breakthrough at Months 12, 24, and 36 [ Time Frame: Months 12, 24, and 36 ]

Show Outcome Measure 9

10. Secondary:

Number of Participants With Alanine Aminotransferase (ALT) Normalization at Months 12, 24, and 36 [ Time Frame: Months 12, 24, and 36 ]

Show Outcome Measure 10

11. Secondary:

Number of Participants Who Were Hepatitis B Envelope Antigen (HBeAg) Positive at Baseline and Developed Undetectable Levels of HBeAg at Months 12, 24, and 36 [ Time Frame: Baseline and Months 12, 24, and 36 ]

Show Outcome Measure 11

12. Secondary:

Number of Participants Who Were HBeAg Positive at Baseline, With HBeAg Seroconversion at Months 12, 24, and 36 [ Time Frame: Baseline and Months 12, 24, and 36 ]

Show Outcome Measure 12

13. Secondary:

Number of Participants Who Were Hepatitis B Surface Antigen (HBsAg) Positive at Baseline and Developed Undetectable Levels of HBsAg at Months 12, 24, and 36 [ Time Frame: Baseline and Months 12, 24, and 36 ]

Show Outcome Measure 13

14. Secondary:

Number of Participants Who Were HBsAg Positive at Baseline, With HBsAg Seroconversion at Months 12, 24, and 36 [ Time Frame: Baseline and Months 12, 24, and 36 ]

Show Outcome Measure 14

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: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire 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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00347009 History of Changes
Other Study ID Numbers:	ADF104070
Study First Received:	June 30, 2006
Results First Received:	September 20, 2010
Last Updated:	March 17, 2011
Health Authority:	Taiwan: Department of Health