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Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00507689
First received: July 25, 2007
Last updated: February 12, 2014
Last verified: February 2014
Results First Received: July 15, 2013  
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: Prevention
Condition: Chronic Hepatitis B
Interventions: Drug: FTC/TDF
Drug: Hepatitis B Immunoglobulin (HBIg)

  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
Participants were enrolled at 7 sites in the United States. The first participant was screened on 12 September 2007. The last participant observation was on 03 May 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
51 participants were screened; 40 received emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)+HBIg in the pre-randomization period; 37 received FTC/TDF+HBIg or FTC/TDF in the randomized period.

Reporting Groups
  Description
FTC/TDF+HBIg For the Participant Flow, this group includes all participants who received any treatment in the pre-randomization period, and participants who received FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
FTC/TDF For the Participant Flow, this group includes participants who received FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily.

Participant Flow for 2 periods

Period 1:   Pre-Randomization Period
    FTC/TDF+HBIg     FTC/TDF  
STARTED     40     0  
COMPLETED     37     0  
NOT COMPLETED     3     0  
Adverse Event                 1                 0  
Physician Decision                 1                 0  
Withdrawal by Subject                 1                 0  

Period 2:   Randomized Period
    FTC/TDF+HBIg     FTC/TDF  
STARTED     19 [1]   18 [2]
COMPLETED     18     16  
NOT COMPLETED     1     2  
Adverse Event                 1                 1  
Withdrawal by Subject                 0                 1  
[1] 19 of 37 participants who completed the pre-randomization period were randomized to FTC/TDF+HBIg.
[2] 18 of 37 participants who completed the pre-randomization period were randomized to FTC/TDF.



  Baseline Characteristics
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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.
Three groups are reported for baseline characteristics: the 2 treatment groups in the randomized period, and non-randomized participants who discontinued prior to the randomized period.

Reporting Groups
  Description
FTC/TDF+HBIg For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
FTC/TDF For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Not Randomized For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period only. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Total Total of all reporting groups

Baseline Measures
    FTC/TDF+HBIg     FTC/TDF     Not Randomized     Total  
Number of Participants  
[units: participants]
  19     18     3     40  
Age  
[units: years]
Mean ± Standard Deviation
  54  ± 9.7     59  ± 9.1     64  ± 6.0     57  ± 9.6  
Gender  
[units: participants]
       
Female     4     3     1     8  
Male     15     15     2     32  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     1     2     0     3  
Not Hispanic or Latino     17     16     3     36  
Unknown or Not Reported     1     0     0     1  
Race/Ethnicity, Customized  
[units: participants]
       
Asian     6     8     1     15  
White     7     5     1     13  
Black     5     4     1     10  
Other     1     1     0     2  
Baseline hepatitis B virus (HBV) DNA Below 169 copies/mL  
[units: participants]
       
< 169 copies/mL     19     18     3     40  
≥ 169 copies/mL     0     0     0     0  
Baseline alanine aminotransferase (ALT) above the upper limit of the normal range (ULN) [1]
[units: participants]
       
> ULN     0     2     0     2  
≤ ULN     19     16     3     38  
[1] The upper limit of the normal range (ULN) for ALT was 34 U/L for females 18-69 years of age, and 32 U/L for females over age 69; the ULN was 43 U/L for males 18-69 years of age, and 35 U/L for males over age 69.



  Outcome Measures
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1.  Primary:   Percentage of Participants With HBV Recurrence Prior to or at Week 72   [ Time Frame: Pretreatment baseline through Week 72 ]

2.  Secondary:   Percentage of Participants With HBV Recurrence at Week 96   [ Time Frame: Week 96 ]

3.  Secondary:   Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72   [ Time Frame: Week 72 ]

4.  Secondary:   Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96   [ Time Frame: Week 96 ]

5.  Secondary:   Percentage of Participants With Normal ALT at Week 72   [ Time Frame: Week 72 ]

6.  Secondary:   Percentage of Participants With Normal ALT at Week 96   [ Time Frame: Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00507689     History of Changes
Other Study ID Numbers: GS-US-203-0107
Study First Received: July 25, 2007
Results First Received: July 15, 2013
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration