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Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection

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ClinicalTrials.gov Identifier: NCT01651403
Recruitment Status : Active, not recruiting
First Posted : July 27, 2012
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Chronic Hepatitis B Infection
Interventions: Drug: Tenofovir DF
Drug: TDF Placebo

  Participant Flow

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 the United States, Asia, and Europe.The first participant was screened on 06 December 2012. The last Week 48 study visit occurred on 07 August 2017.

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

Reporting Groups
  Description
Tenofovir Disoproxil Fumarate

Blinded Randomized Phase: Tenofovir disoproxil fumarate (TDF) tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)

Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.

Placebo

Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)

Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.


Participant Flow:   Overall Study
    Tenofovir Disoproxil Fumarate   Placebo
STARTED   60   30 
COMPLETED   5   1 
NOT COMPLETED   55   29 
Continuing Study                48                22 
Subject Noncompliance                1                1 
Withdrew Consent/Assent                5                5 
Investigator Decision                1                0 
Subjects Randomized and Not Treated                0                1 



  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: all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase.

Reporting Groups
  Description
Tenofovir Disoproxil Fumarate

Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)

Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.

Placebo

Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)

Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.

Total Total of all reporting groups

Baseline Measures
   Tenofovir Disoproxil Fumarate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   29   89 
Age 
[Units: Years]
Mean (Standard Deviation)
 6  (2.5)   7  (3.2)   6  (2.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  45.0%      12  41.4%      39  43.8% 
Male      33  55.0%      17  58.6%      50  56.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      60 100.0%      29 100.0%      89 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      41  68.3%      17  58.6%      58  65.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   6.7%      1   3.4%      5   5.6% 
White      15  25.0%      11  37.9%      26  29.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
South Korea   23   11   34 
Romania   13   10   23 
United States   14   3   17 
Taiwan   2   0   2 
India   8   5   13 
HBV DNA 
[Units: Log10 IU/mL]
Mean (Standard Deviation)
 8.089  (0.7208)   8.133  (1.2538)   8.103  (0.9214) 
Hepatitis B Virus Surface Antigen (HBsAg) 
[Units: Participants]
Count of Participants
     
Positive      60 100.0%      29 100.0%      89 100.0% 
Negative      0   0.0%      0   0.0%      0   0.0% 
Hepatitis B e antigen (HBeAg) 
[Units: Participants]
Count of Participants
     
Positive      56  93.3%      29 100.0%      85  95.5% 
Negative      4   6.7%      0   0.0%      4   4.5% 
HBeAb 
[Units: Participants]
Count of Participants
     
Positive      4   6.7%      0   0.0%      4   4.5% 
Negative or Missing      56  93.3%      29 100.0%      85  95.5% 
Spine Bone Mineral Density 
[Units: G/cm^2]
Mean (Standard Deviation)
 0.586  (0.1196)   0.626  (0.1567)   0.599  (0.1332) 


  Outcome Measures

1.  Primary:   Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48   [ Time Frame: Week 48 ]

3.  Secondary:   Percentage of Participants With Normal ALT at Week 48   [ Time Frame: Week 48 ]

4.  Secondary:   Percentage of Participants With Normalized ALT at Week 48   [ Time Frame: Week 48 ]

5.  Secondary:   Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT at Week 48   [ Time Frame: Week 48 ]

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

7.  Secondary:   Percentage of Participants With HBsAg Loss   [ Time Frame: Week 48 ]

8.  Secondary:   Percentage of Participants With HBsAg Seroconversion   [ Time Frame: Week 48 ]

9.  Secondary:   Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48   [ Time Frame: Baseline; Week 48 ]

10.  Secondary:   Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density   [ Time Frame: Baseline; Week 48 ]

11.  Secondary:   Percent Change From Baseline in Bone Mineral Density of Spine   [ Time Frame: Baseline; Week 48 ]

12.  Secondary:   Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96   [ Time Frame: Baseline; Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Secondary:   Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144   [ Time Frame: Baseline; Week 144 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: Gilead Clinical Study Information Center
Organization: Gilead Sciences
phone: 1-833-445-3230 (GILEAD-0)
e-mail: GileadClinicalTrials@gilead.com



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01651403     History of Changes
Other Study ID Numbers: GS-US-174-0144
2012-000586-20 ( EudraCT Number )
First Submitted: July 25, 2012
First Posted: July 27, 2012
Results First Submitted: August 3, 2018
Results First Posted: September 19, 2018
Last Update Posted: September 19, 2018