A Study to Evaluate Tenofovir Disoproxil Fumarate (DF) in Asian-American Adults With Chronic Hepatitis B Infection

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT00736190

First received: August 13, 2008

Last updated: November 30, 2011

Last verified: November 2011

History of Changes

Results First Received: July 7, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Chronic Hepatitis B
Intervention:	Drug: Tenofovir disoproxil fumarate

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
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Reporting Groups

	Description
A: TDF	Tenofovir disoproxil fumarate (TDF) 300 mg by mouth daily

Participant Flow: Overall Study

	A: TDF
STARTED	90
COMPLETED	87
NOT COMPLETED	3
Pregnancy	1
Withdrawal by Subject	1
Adverse Event	1

Baseline Characteristics

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Reporting Groups

	Description
A: TDF	Tenofovir disoproxil fumarate 300 mg by mouth daily

Baseline Measures

	A: TDF
Number of Participants [units: participants]	90
Age [units: years] Mean ± Standard Deviation	36.8 ± 10.49
Gender [units: participants]
Female	43
Male	47
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0
Asian	90
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	0
More than one race	0
Unknown or Not Reported	0
Region of Enrollment [units: participants]
United States	90
Ethnicity [units: Participants]
Asian-Chinese	58
Asian-Korean	12
Asian-Vietnamese	19
Asian-Cambodian	1
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ^[1] [units: log10 copies/mL] Mean ± Standard Deviation	7.484 ± 1.7678
Hepatitis B e antigen (HBeAg) ^[2] [units: Participants]
Positive	53
Negative	37
Antibody to HBeAg (Anti-HBe) ^[2] [units: Participants]
Positive	38
Unknown	52
Positive Hepatitis B surface antigen (HBsAg) ^[2] [units: Participants]	90
Alanine aminotransferase (ALT); upper limit of normal (ULN) = 34 U/L ^[3] [units: U/L] Mean ± Standard Deviation	103.5 ± 149.61
ALT (Multiples of ULN) ^[4] [units: multiples of ULN] Mean ± Standard Deviation	2.628 ± 3.5698
ALT ^[5] [units: Participants]
>ULN	67
<=ULN	23
HBV genotype ^[6] [units: Participants]
Genotype B	43
Genotype C	47

[1]	Plasma HBV DNA was analyzed using polymerase chain reaction (PCR) method.
[2]	Blood samples were collected for HBV serology.
[3]	Blood samples were collected for serum chemistry.
[4]	Blood samples were collected for serum chemistry. Multiples are based on ULN of 34 U/L.
[5]	Blood samples were collected for serum chemistry. The ULN for ALT was 34 U/L.
[6]	Genotypic analysis was conducted at baseline for all participants.

Outcome Measures

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1. Primary:

Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL) [ Time Frame: Week 48 ]

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2. Secondary:

Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48 [ Time Frame: Week 48 ]

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3. Secondary:

Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48 [ Time Frame: Week 48 ]

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4. Secondary:

Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48 [ Time Frame: Week 48 ]

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5. Secondary:

Change From Baseline in FibroTest Value [ Time Frame: Baseline and Week 48 ]

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6. Secondary:

Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion [ Time Frame: Week 48 ]

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7. Secondary:

Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48 [ Time Frame: Week 48 ]

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8. Secondary:

Summary of Resistance Surveillance for Participants Without Virologic Breakthrough [ Time Frame: Week 48 ]

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9. Secondary:

Summary of Resistance Surveillance for Participants With Virologic Breakthrough [ Time Frame: Week 48 ]

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Measure Type	Secondary
Measure Title	Summary of Resistance Surveillance for Participants With Virologic Breakthrough
Measure Description	Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.
Time Frame	Week 48
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
2 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and had virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).

Reporting Groups

	Description
Tenofovir DF	300-mg tablet (marketed formulation) taken orally once daily

Measured Values

	Tenofovir DF
Number of Participants Analyzed [units: participants]	2
Summary of Resistance Surveillance for Participants With Virologic Breakthrough [units: Participants]
No changes in HBV pol/RT	2
Changes at polymorphic sites	0
Changes at conserved sites	0
Unable to genotype	0

No statistical analysis provided for Summary of Resistance Surveillance for Participants With Virologic Breakthrough

10. Secondary:

Summary of Resistance Surveillance for Participants Who Discontinued the Study Early [ Time Frame: Week 48 ]

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11. Secondary:

Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss [ Time Frame: Week 48 ]

Results not yet posted. Anticipated Posting Date: 01/2099 Safety Issue: No

12. Secondary:

Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe [ Time Frame: Week 48 ]

Results not yet posted. Anticipated Posting Date: 01/2099 Safety Issue: No

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: Investigators may discuss or publish results (without Gilead’s confidential information) after all results have been publicly disclosed by/with consent of Gilead or study has been completed >=2 years. Proposed publication/presentation and destination details must be submitted >=30 days before submission. The investigator agrees to withhold publication or presentation for an additional 60 days in order to obtain patent protection if deemed necessary.

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: Eduardo Bruno Martins, MD, DPhil, Sr. Director, Medical Affairs - Hepatitis
Organization: Gilead Sciences, Inc.
phone: 650-522-5792
e-mail: eduardo.martins@gilead.com

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00736190 History of Changes
Other Study ID Numbers:	GS-US-174-0123
Study First Received:	August 13, 2008
Results First Received:	July 7, 2011
Last Updated:	November 30, 2011
Health Authority:	United States: Food and Drug Administration

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