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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01940471
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 HBV 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 25 August 2013. The last Week 48 study visit occurred on 16 November 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1473 participants were screened.

Reporting Groups
  Description
TAF 25 mg Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
TDF 300 mg TDF 300 mg tablet + TAF placebo tablet 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   582   293 
COMPLETED   14   8 
NOT COMPLETED   568   285 
Randomized but Never Treated                1                1 
Withdrew Consent                11                5 
Adverse Event                6                3 
Lost to Follow-up                2                2 
Pregnancy                2                1 
Investigator's Discretion                2                1 
Non-Compliance with Study Drug                2                1 
Protocol-Specified Criteria                2                0 
Death                1                0 
Lack of Efficacy                1                0 
Protocol Violation                0                1 
HBsAg Seroconversion                1                0 
Still on Double-Blind Treatment                537                270 

Period 2:   Open-Label Extension
    TAF 25 mg   TDF 300 mg
STARTED   14   8 
COMPLETED   0   0 
NOT COMPLETED   14   8 
Still on Open-Label Treatment                14                8 



  Baseline Characteristics
  Hide Baseline Characteristics

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 drug

Reporting Groups
  Description
TAF 25 mg TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
TDF 300 mg TDF 300 mg tablet + TAF placebo tablet 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]
 581   292   873 
Age 
[Units: Years]
Mean (Standard Deviation)
 38  (11.0)   38  (11.7)   38  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      210  36.1%      103  35.3%      313  35.9% 
Male      371  63.9%      189  64.7%      560  64.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian   482   232   714 
Black or African American   2   3   5 
Native Hawaiian or Pacific Islander   1   3   4 
White   96   53   149 
Other   0   1   1 
Hispanic or Latino   4   2   6 
Not Hispanic or Latino   573   289   862 
Not Permitted   4   1   5 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Russian Federation   33   16   49 
Romania   24   9   33 
Singapore   7   2   9 
Hong Kong   71   50   121 
United States   33   21   54 
Japan   35   11   46 
United Kingdom   5   3   8 
India   77   33   110 
Spain   4   0   4 
New Zealand   11   6   17 
Canada   55   28   83 
Turkey   15   11   26 
Taiwan   54   29   83 
Korea, Republic of   120   53   173 
Poland   7   5   12 
Italy   9   5   14 
Australia   14   6   20 
Bulgaria   4   2   6 
France   3   2   5 
HBV DNA 
[Units: Log10 IU/mL]
Mean (Standard Deviation)
 7.6  (1.34)   7.6  (1.41)   7.6  (1.36) 
Plasma HBV DNA Level 
[Units: Participants]
Count of Participants
     
< 8 log10 IU/mL   309   150   459 
≥ 8 log10 IU/mL   272   142   414 
IL28B Genotype [1] 
[Units: Participants]
Count of Participants
     
CC   442   210   652 
CT   112   69   181 
TT   23   10   33 
Missing   4   3   7 
[1] The CC, CT, and TT alleles are different forms of the IL28b gene.
Oral Antiviral Treatment Status 
[Units: Participants]
Count of Participants
     
Treatment Experienced   151   77   228 
Treatment Naive   430   215   645 
Proteinuria by Urinalysis (dipstick) [1] 
[Units: Participants]
Count of Participants
     
Grade 0   538   259   797 
Grade 1   40   31   71 
Grade 2   3   2   5 
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:   Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48   [ Time Frame: Week 48 ]

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

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

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

6.  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
  Hide 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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  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: NCT01940471     History of Changes
Other Study ID Numbers: GS-US-320-0110
2013-000636-10 ( EudraCT Number )
Study First Received: August 20, 2013
Results First Received: December 9, 2016
Last Updated: February 10, 2017