ClinicalTrials.gov
ClinicalTrials.gov Menu

Tenofovir Alone Versus Tenofovir With Emtricitabine to Treat Chronic Hepatitis B

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.
ClinicalTrials.gov Identifier: NCT00524173
Recruitment Status : Terminated
First Posted : September 3, 2007
Results First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatitis B
Interventions: Drug: Tenofovir & Emtricitabine
Drug: Tenofovir

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tenofovir Only

Tenofovir 300mg by mouth daily for 192 weeks

Tenofovir

Tenofovir & Emtricitabine

Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks

Tenofovir & Emtricitabine


Participant Flow:   Overall Study
    Tenofovir Only   Tenofovir & Emtricitabine
STARTED   17   15 
COMPLETED   12   13 
NOT COMPLETED   5   2 
Lost to Follow-up                0                1 
Death                1                0 
Had not reached endpoint at study close                4                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.
No text entered.

Reporting Groups
  Description
Tenofovir Only

Tenofovir 300mg by mouth daily for 192 weeks

Tenofovir

Tenofovir & Emtricitabine

Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks

Tenofovir & Emtricitabine

Total Total of all reporting groups

Baseline Measures
   Tenofovir Only   Tenofovir & Emtricitabine   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   15   32 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.65  (16.66)   39.47  (12.67)   39.56  (14.69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  11.8%      5  33.3%      7  21.9% 
Male      15  88.2%      10  66.7%      25  78.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian   10   10   20 
Black   4   0   4 
White   3   5   8 


  Outcome Measures

1.  Primary:   Number of Subjects With HBV DNA <1000 IU/ml at Week 48   [ Time Frame: At Week 48 ]

2.  Primary:   Number of Participants With HBV DNA <1000 IU/ml at Week 192   [ Time Frame: At Week 192 ]

3.  Secondary:   Number of Participants With Normalized ALT   [ Time Frame: 192 weeks ]

4.  Secondary:   Loss of HBsAg   [ Time Frame: 192 weeks ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Marc Ghany, MD
Organization: NIDDK
phone: 301-402-5115
e-mail: marcg@intra.niddk.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00524173     History of Changes
Other Study ID Numbers: 070207
07-DK-0207
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: March 20, 2018
Results First Posted: April 18, 2018
Last Update Posted: April 18, 2018