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Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01940341
First received: August 20, 2013
Last updated: February 10, 2017
Last verified: February 2017
Results First Received: December 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Conditions: HBV
Chronic HIV Infection
Interventions: Drug: TAF
Drug: TDF
Drug: TAF Placebo
Drug: TDF Placebo

  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 study sites in East Asia, Europe, North America, Australia, India, and New Zealand. The first participant was screened on 12 September 2013. The last Week 48 study visit occurred on 24 September 2015.

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

Reporting Groups
  Description
TAF 25 mg Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
TDF 300 mg TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)

Participant Flow for 2 periods

Period 1:   Double-Blind Phase
    TAF 25 mg   TDF 300 mg
STARTED   285   141 
COMPLETED   4   1 
NOT COMPLETED   281   140 
Randomized but Never Treated                0                1 
Adverse Event                3                2 
Withdrew Consent                3                2 
Lost to Follow-up                4                1 
Pregnancy                0                1 
Investigator's Discretion                1                0 
Non-Compliance with Study Drug                0                1 
Protocol Specified Criteria                1                0 
Still on Double-Blind Treatment                269                132 

Period 2:   Open-label Extension Phase
    TAF 25 mg   TDF 300 mg
STARTED   4   1 
COMPLETED   0   0 
NOT COMPLETED   4   1 
Still on Study                4                1 



  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 received at least 1 dose of study drugs.

Reporting Groups
  Description
TAF 25 mg TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
TDF 300 mg TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
Total Total of all reporting groups

Baseline Measures
   TAF 25 mg   TDF 300 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 285   140   425 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (11.6)   48  (10.4)   46  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      112  39.3%      54  38.6%      166  39.1% 
Male      173  60.7%      86  61.4%      259  60.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   2   0   2 
Not Hispanic or Latino   279   140   419 
Not Permitted   4   0   4 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian   205   101   306 
Black or African American   5   3   8 
Native Hawaiian or Pacific Islander   2   0   2 
White   71   35   106 
Other   2   1   3 
Region of Enrollment 
[Units: Participants]
     
Russian Federation   22   13   35 
Romania   13   8   21 
Hong Kong   41   28   69 
United States   24   13   37 
Japan   21   6   27 
United Kingdom   5   1   6 
India   26   7   33 
Spain   3   0   3 
New Zealand   10   2   12 
Canada   29   17   46 
Turkey   10   4   14 
Taiwan   22   15   37 
Poland   12   6   18 
Italy   6   3   9 
Australia   9   1   10 
France   2   1   3 
Korea, Republic of   30   15   45 
IL28b Status [1] 
[Units: Participants]
Count of Participants
     
CC   209   106   315 
CT   65   23   88 
TT   10   9   19 
Missing   1   2   3 
[1] The CC, CT, and TT alleles are different forms of the IL28b gene.
HBV DNA 
[Units: Log10 IU/mL]
Mean (Standard Deviation)
 5.7  (1.34)   5.8  (1.32)   5.8  (1.33) 
Plasma HBV DNA Level 
[Units: Participants]
Count of Participants
     
< 7 log10 IU/mL   230   116   346 
≥ 7 log10 IU/mL - < 8 log10 IU/mL   42   20   62 
≥ 8 log10 IU/mL   13   4   17 
Oral antiviral (OAV) treatment status 
[Units: Participants]
Count of Participants
     
Treatment Experienced   60   31   91 
Treatment Naive   225   109   334 
Proteinuria by Urinalysis (dipstick) [1] 
[Units: Participants]
Count of Participants
     
Grade 0   270   135   405 
Grade 1   13   5   18 
Grade 2   2   0   2 
Grade 3   0   0   0 
[1] Urine protein was measured using the dipstick method. Grade 0 = Absent; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL   [ Time Frame: Week 48 ]

2.  Secondary:   Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48   [ Time Frame: Baseline; Week 48 ]

3.  Secondary:   Percent Change From Baseline in Spine BMD at Week 48   [ Time Frame: Baseline; Week 48 ]

4.  Secondary:   Change From Baseline in Serum Creatinine at Week 48   [ Time Frame: Baseline; Week 48 ]

5.  Other Pre-specified:   Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48   [ Time Frame: Up to 48 weeks ]


  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



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01940341     History of Changes
Other Study ID Numbers: GS-US-320-0108
2013-000626-63 ( EudraCT Number )
Study First Received: August 20, 2013
Results First Received: December 9, 2016
Last Updated: February 10, 2017