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Trial record 1 of 1 for:    NCT01320943
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Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB (FINITE CHB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320943
First Posted: March 23, 2011
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
Results First Submitted: July 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Hepatitis B
Interventions: Drug: TDF
Other: Stop TDF

  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 13 study sites in Germany. The first participant was screened on 26 April 2011. The last study visit occurred on 23 August 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
65 participants were screened.

Reporting Groups
  Description
Stop TDF Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline.
Continue TDF Participants continued TDF monotherapy 300 mg once daily.

Participant Flow:   Overall Study
    Stop TDF   Continue TDF
STARTED   21 [1]   22 
COMPLETED   20   20 
NOT COMPLETED   1   2 
Lost to Follow-up                1                0 
Physician Decision                0                1 
Randomized but not Treated                0                1 
[1] 13 participants did not restart TDF; 8 participants restarted TDF during the study.



  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.
Safety Analysis Set: participants who were either randomized to Arm A (Stop TDF) and had a baseline visit, or who were randomized to Arm B (Continue TDF) and received at least one dose of study drug

Reporting Groups
  Description
Stop TDF Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline.
Continue TDF Participants continued TDF monotherapy 300 mg once daily.
Total Total of all reporting groups

Baseline Measures
   Stop TDF   Continue TDF   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   21   42 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.6  (10.51)   45.0  (7.06)   44.8  (8.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  14.3%      6  28.6%      9  21.4% 
Male      18  85.7%      15  71.4%      33  78.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian   1   1   2 
Black or African American   1   0   1 
White   18   19   37 
Other   1   1   2 
Hepatitis B Virus Surface Antigen 
[Units: Log10 IU/mL]
Mean (Standard Deviation)
 4.4  (0.71)   4.5  (0.35)   4.5  (0.56) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms   [ Time Frame: Week 144 ]

2.  Secondary:   Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144   [ Time Frame: Weeks 96 and 144 ]

3.  Secondary:   Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms   [ Time Frame: Baseline to Week 144 ]

4.  Secondary:   Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm   [ Time Frame: Weeks 48, 96, and 144 ]

5.  Secondary:   Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups)   [ Time Frame: Baseline to Week 144 ]

6.  Secondary:   Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF)   [ Time Frame: Baseline to Week 144 ]

7.  Secondary:   Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms   [ 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
e-mail: ClinicalTrialDisclosures@gilead.com


Publications of Results:
Berg T, Schott E, Felten G, Eisenbach C, Welzel TM, Warger T, et al. Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-Negative CHB: Two Cases From an Ongoing Randomized, Controlled Trial [Poster Number P47] The Viral Hepatitis Congress; 2012 September 7-9; Frankfurt am Main, Germany.
Berg T, Simon K-G, Mauss S, Schott E, Heyne R, Klass D, et al. Stopping Tenofovir Disoproxil Fumarate Treatment After Long-Term Virologic Suppression in HBeAg-Negative CHB: Week 48 Interim Results From an Ongoing Randomized, Controlled Trial ("FINITE CHB") [Presentation P119]. The European Association for the Study of the Liver (EASL). 50th International Liver Congress; 2015 22-26 April; Vienna, Austria.


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01320943     History of Changes
Other Study ID Numbers: GS-EU-174-0160
2010-021925-12 ( EudraCT Number )
First Submitted: March 9, 2011
First Posted: March 23, 2011
Results First Submitted: July 27, 2017
Results First Posted: August 29, 2017
Last Update Posted: August 29, 2017