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Tenofovir Alone Versus Tenofovir With Emtricitabine to Treat Chronic Hepatitis B

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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
Enrollment 35

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tenofovir Only Tenofovir & Emtricitabine
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Tenofovir 300mg by mouth daily for 192 weeks

Tenofovir

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

Tenofovir & Emtricitabine

Period Title: Overall Study
Started 17 15
Completed 12 13
Not Completed 5 2
Reason Not Completed
Lost to Follow-up             0             1
Death             1             0
Had not reached endpoint at study close             4             1
Arm/Group Title Tenofovir Only Tenofovir & Emtricitabine Total
Hide Arm/Group Description

Tenofovir 300mg by mouth daily for 192 weeks

Tenofovir

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

Tenofovir & Emtricitabine

Total of all reporting groups
Overall Number of Baseline Participants 17 15 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 15 participants 32 participants
39.65  (16.66) 39.47  (12.67) 39.56  (14.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 32 participants
Female
2
  11.8%
5
  33.3%
7
  21.9%
Male
15
  88.2%
10
  66.7%
25
  78.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 32 participants
Asian
10
  58.8%
10
  66.7%
20
  62.5%
Black
4
  23.5%
0
   0.0%
4
  12.5%
White
3
  17.6%
5
  33.3%
8
  25.0%
1.Primary Outcome
Title Number of Subjects With HBV DNA <1000 IU/ml at Week 48
Hide Description Number of subjects with HBV DNA <1000 IU/ml at Week 48
Time Frame At Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tenofovir Only Tenofovir & Emtricitabine
Hide Arm/Group Description:

Tenofovir 300mg by mouth daily for 192 weeks

Tenofovir

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

Tenofovir & Emtricitabine

Overall Number of Participants Analyzed 12 13
Measure Type: Count of Participants
Unit of Measure: Participants
11
  91.7%
13
 100.0%
2.Primary Outcome
Title Number of Participants With HBV DNA <1000 IU/ml at Week 192
Hide Description Number of participants with HBV DNA <1000 IU/ml at Week 192
Time Frame At Week 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tenofovir Only Tenofovir & Emtricitabine
Hide Arm/Group Description:

Tenofovir 300mg by mouth daily for 192 weeks

Tenofovir

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

Tenofovir & Emtricitabine

Overall Number of Participants Analyzed 12 13
Measure Type: Count of Participants
Unit of Measure: Participants
12
 100.0%
12
  92.3%
3.Secondary Outcome
Title Number of Participants With Normalized ALT
Hide Description Number of participants with normalized ALT
Time Frame 192 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tenofovir Only Tenofovir & Emtricitabine
Hide Arm/Group Description:

Tenofovir 300mg by mouth daily for 192 weeks

Tenofovir

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

Tenofovir & Emtricitabine

Overall Number of Participants Analyzed 12 13
Measure Type: Count of Participants
Unit of Measure: Participants
8
  66.7%
13
 100.0%
4.Secondary Outcome
Title Loss of HBsAg
Hide Description [Not Specified]
Time Frame 192 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tenofovir Only Tenofovir & Emtricitabine
Hide Arm/Group Description:

Tenofovir 300mg by mouth daily for 192 weeks

Tenofovir

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

Tenofovir & Emtricitabine

Overall Number of Participants Analyzed 12 13
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
0
   0.0%
Time Frame 192 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tenofovir Only Tenofovir & Emtricitabine
Hide Arm/Group Description

Tenofovir 300mg by mouth daily for 192 weeks

Tenofovir

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

Tenofovir & Emtricitabine

All-Cause Mortality
Tenofovir Only Tenofovir & Emtricitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/17 (5.88%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Tenofovir Only Tenofovir & Emtricitabine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      0/15 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death *  1/17 (5.88%)  1 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tenofovir Only Tenofovir & Emtricitabine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/17 (41.18%)      10/15 (66.67%)    
Blood and lymphatic system disorders     
Neutrophils (<750mm^3) *  1/17 (5.88%)  0/15 (0.00%) 
Endocrine disorders     
Serum amylase >2xULN *  0/17 (0.00%)  1/15 (6.67%) 
Hepatobiliary disorders     
Aalanine aminotransferase >5xULN *  2/17 (11.76%)  3/15 (20.00%) 
Aspartate Aminotransferase > 5xULN *  1/17 (5.88%)  3/15 (20.00%) 
Musculoskeletal and connective tissue disorders     
Creatine kinase > 4xULN *  3/17 (17.65%)  3/15 (20.00%) 
*
Indicates events were collected by non-systematic assessment
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
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