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Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB (FINITE CHB)

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ClinicalTrials.gov Identifier: NCT01320943
Recruitment Status : Completed
First Posted : March 23, 2011
Results First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis B
Interventions Drug: TDF
Other: Stop TDF
Enrollment 43
Recruitment Details Participants were enrolled at 13 study sites in Germany. The first participant was screened on 26 April 2011. The last study visit occurred on 23 August 2016.
Pre-assignment Details 65 participants were screened.
Arm/Group Title Stop TDF Continue TDF
Hide Arm/Group Description Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline. Participants continued TDF monotherapy 300 mg once daily.
Period Title: Overall Study
Started 21 [1] 22
Completed 20 20
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             0
Physician Decision             0             1
Randomized but not Treated             0             1
[1]
13 participants did not restart TDF; 8 participants restarted TDF during the study.
Arm/Group Title Stop TDF Continue TDF Total
Hide Arm/Group Description Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline. Participants continued TDF monotherapy 300 mg once daily. Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were either randomized to Arm A (Stop TDF) and had a baseline visit, or who were randomized to Arm B (Continue TDF) and received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
44.6  (10.51) 45.0  (7.06) 44.8  (8.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
3
  14.3%
6
  28.6%
9
  21.4%
Male
18
  85.7%
15
  71.4%
33
  78.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Asian
1
   4.8%
1
   4.8%
2
   4.8%
Black or African American
1
   4.8%
0
   0.0%
1
   2.4%
White
18
  85.7%
19
  90.5%
37
  88.1%
Other
1
   4.8%
1
   4.8%
2
   4.8%
Hepatitis B Virus Surface Antigen  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 21 participants 21 participants 42 participants
4.4  (0.71) 4.5  (0.35) 4.5  (0.56)
1.Primary Outcome
Title Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms
Hide Description HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Time Frame Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least one post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.
Arm/Group Title Stop TDF Continue TDF
Hide Arm/Group Description:
Participants stopped tenofovir disoproxil fumarate monotherapy at baseline.
Participants continued TDF monotherapy 300 mg once daily.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.236
(0.095 to 0.516)
0 [1] 
(NA to NA)
[1]
No participants in the Continue TDF group had HBsAg loss.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stop TDF, Continue TDF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments Log-rank test statistic was used to compare the time to HBsAg loss between the two treatment arms.
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144
Hide Description HBsAg seroconversion is defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. Proportions are based on the Kaplan-Meier estimate.
Time Frame Weeks 96 and 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least 1 post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.
Arm/Group Title Stop TDF Continue TDF
Hide Arm/Group Description:
Participants stopped tenofovir disoproxil fumarate monotherapy at baseline.
Participants continued TDF monotherapy 300 mg once daily.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
HBsAg Seroconversion at Week 96
0.056
(0.008 to 0.334)
0 [1] 
(NA to NA)
HBsAg Seroconversion at Week 144
0.203
(0.069 to 0.513)
0 [2] 
(NA to NA)
[1]
No participants in the Continue TDF arm achieved HBsAg seroconversion at Week 96
[2]
No participants in the Continue TDF arm achieved HBsAg seroconversion at Week 144
3.Secondary Outcome
Title Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms
Hide Description
  • The analyses were summarized by 3 treatment subgroups: Stop TDF (TDF-Free), Restart TDF, and Continue TDF
  • When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. For Restart TDF group, baseline is defined as the last available record on or prior to the restart date of TDF.
Time Frame Baseline to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set ( participants who were randomized to Stop TDF arm and had a baseline visit or who were randomized to Continue TDF arm and received at least 1 dose of study drug) with available data were analyzed.
Arm/Group Title Stop TDF (TDF-Free) Restart TDF Continue TDF
Hide Arm/Group Description:
Participants who stopped TDF monotherapy at baseline. Participants in this group were TDF free.
Stop TDF participants who restarted TDF therapy
Participants who continued TDF monotherapy 300 mg once daily.
Overall Number of Participants Analyzed 21 8 21
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change from Baseline at Week 2 Number Analyzed 21 participants 0 participants 21 participants
-0.03  (0.139) NA [1]   (NA)
Change from Baseline at Week 4 Number Analyzed 20 participants 0 participants 20 participants
-0.03  (0.170) -0.01  (0.105)
Change from Baseline at Week 6 Number Analyzed 20 participants 0 participants 21 participants
-0.02  (0.192) NA [2]   (NA)
Change from Baseline at Week 8 Number Analyzed 20 participants 0 participants 21 participants
0.04  (0.500) NA [3]   (NA)
Change from Baseline at Week 10 Number Analyzed 20 participants 0 participants 21 participants
0.01  (0.556) NA [4]   (NA)
Change from Baseline at Week 12 Number Analyzed 19 participants 1 participants 21 participants
-0.11  (0.621) -0.03 -0.02  (0.137)
Change from Baseline at Week 16 Number Analyzed 19 participants 2 participants 21 participants
-0.35  (0.741) -0.73  (0.438) NA [5]   (NA)
Change from Baseline at Week 20 Number Analyzed 18 participants 1 participants 21 participants
-0.48  (0.949) -0.42 NA [6]   (NA)
Change from Baseline at Week 24 Number Analyzed 18 participants 2 participants 21 participants
-0.56  (1.029) -1.41  (1.211) -0.07  (0.139)
Change from Baseline at Week 28 Number Analyzed 17 participants 3 participants 21 participants
-0.60  (0.969) -0.88  (0.916) NA [7]   (NA)
Change from Baseline at Week 32 Number Analyzed 16 participants 3 participants 21 participants
-0.77  (1.126) -0.96  (1.211) NA [8]   (NA)
Change from Baseline at Week 36 Number Analyzed 17 participants 2 participants 21 participants
-0.67  (1.151) -0.26  (0.461) -0.08  (0.140)
Change from Baseline at Week 40 Number Analyzed 18 participants 3 participants 21 participants
-0.78  (1.198) -0.97  (1.275) NA [9]   (NA)
Change from Baseline at Week 44 Number Analyzed 17 participants 1 participants 21 participants
-0.87  (1.238) -0.59 NA [10]   (NA)
Change from Baseline at Week 48 Number Analyzed 18 participants 3 participants 20 participants
-0.88  (1.314) -1.01  (1.295) -0.11  (0.101)
Change from Baseline at Week 60 Number Analyzed 18 participants 3 participants 21 participants
-0.96  (1.353) -1.03  (1.236) -0.10  (0.133)
Change from Baseline at Week 72 Number Analyzed 16 participants 5 participants 20 participants
-1.22  (1.478) -0.64  (1.085) -0.14  (0.142)
Change from Baseline at Week 84 Number Analyzed 16 participants 5 participants 21 participants
-1.21  (1.555) -0.69  (1.084) -0.16  (0.164)
Change from Baseline at Week 96 Number Analyzed 16 participants 5 participants 20 participants
-1.22  (1.530) -0.69  (1.031) -0.17  (0.159)
Change from Baseline at Week 108 Number Analyzed 16 participants 5 participants 20 participants
-1.43  (1.573) -0.69  (1.088) -0.17  (0.145)
Change from Baseline at Week 120 Number Analyzed 14 participants 7 participants 20 participants
-1.56  (1.752) -0.58  (0.870) -0.20  (0.136)
Change from Baseline at Week 132 Number Analyzed 13 participants 7 participants 20 participants
-1.74  (1.829) -0.52  (0.941) -0.22  (0.172)
Change from Baseline at Week 144 Number Analyzed 13 participants 8 participants 20 participants
-1.80  (1.796) -0.51  (0.861) -0.22  (0.160)
[1]
HBsAg assessment in the Continue TDF arm was not performed at Week 2.
[2]
HBsAg assessment in the Continue TDF arm was not performed at Week 6.
[3]
HBsAg assessment in the Continue TDF arm was not performed at Week 8.
[4]
HBsAg assessment in the Continue TDF arm was not performed at Week 10.
[5]
HBsAg assessment in the Continue TDF arm was not performed at Week 16.
[6]
HBsAg assessment in the Continue TDF arm was not performed at Week 20.
[7]
HBsAg assessment in the Continue TDF arm was not performed at Week 28.
[8]
HBsAg assessment in the Continue TDF arm was not performed at Week 32.
[9]
HBsAg assessment in the Continue TDF arm was not performed at Week 40.
[10]
HBsAg assessment in the Continue TDF arm was not performed at Week 44.
4.Secondary Outcome
Title Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm
Hide Description [Not Specified]
Time Frame Weeks 48, 96, and 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): participants who were randomized to Stop TDF group and had a baseline visit or who were randomized to Continue TDF group and received at least 1 dose of study drug. Proportions are based on the Kaplan-Meier estimate.
Arm/Group Title Stop TDF
Hide Arm/Group Description:
Participants stopped TDF monotherapy at baseline.
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
TDF Restart at Week 48
0.143
(0.048 to 0.380)
TDF Restart at Week 96
0.238
(0.107 to 0.481)
TDF Restart at Week 144
0.381
(0.212 to 0.619)
5.Secondary Outcome
Title Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups)
Hide Description Viral suppression is defined as 2 consecutive assessments of HBV DNA < 400 copies/mL (69 IU/mL) through Week 144.
Time Frame Baseline to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the FAS with available data were analyzed. When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. 1 participant restarted TDF during Wk 72, thus was reported in both Stop TDF and Restart TDF arms based on the TDF restart date.
Arm/Group Title Stop TDF (TDF-Free) Re-Start TDF
Hide Arm/Group Description:
Participants stopped TDF monotherapy at baseline. Participants in this group were TDF free.
Stop TDF participants who restarted TDF therapy
Overall Number of Participants Analyzed 21 8
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 21 participants 0 participants
52.4
Week 4 Number Analyzed 19 participants 0 participants
5.3
Week 6 Number Analyzed 20 participants 0 participants
10.0
Week 8 Number Analyzed 20 participants 0 participants
5.0
Week 10 Number Analyzed 20 participants 0 participants
15.0
Week12 Number Analyzed 19 participants 1 participants
21.1 0
Week 16 Number Analyzed 19 participants 2 participants
31.6 0
Week 20 Number Analyzed 18 participants 2 participants
27.8 0
Week 24 Number Analyzed 18 participants 2 participants
16.7 0
Week 28 Number Analyzed 17 participants 3 participants
17.6 0
Week 32 Number Analyzed 16 participants 3 participants
12.5 66.7
Week 36 Number Analyzed 17 participants 2 participants
29.4 100.0
Week 40 Number Analyzed 18 participants 3 participants
22.2 100.0
Week 44 Number Analyzed 17 participants 1 participants
29.4 100.0
Week 48 Number Analyzed 18 participants 3 participants
27.8 100.0
Week 60 Number Analyzed 18 participants 3 participants
33.3 100.0
Week 72 Number Analyzed 17 participants 5 participants
35.3 60.0
Week 84 Number Analyzed 16 participants 5 participants
31.3 100.0
Week 96 Number Analyzed 16 participants 5 participants
37.5 100.0
Week 108 Number Analyzed 16 participants 5 participants
37.5 100.0
Week 120 Number Analyzed 15 participants 7 participants
40.0 71.4
Week 132 Number Analyzed 13 participants 7 participants
38.5 100.0
Week 144 Number Analyzed 13 participants 8 participants
46.2 87.5
6.Secondary Outcome
Title Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF)
Hide Description [Not Specified]
Time Frame Baseline to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Percentages are based on the number of participants with non-missing laboratory test results at each visit. One participant restarted TDF during Weeks 72 and 120 and thus was reported in both the Stop TDF and Re-Start TDF groups based on the date of TDF restart.
Arm/Group Title Stop TDF (TDF-Free) Re-Start TDF
Hide Arm/Group Description:
Participants who stopped TDF monotherapy at baseline. Participants in this group were TDF free.
Stop TDF participants who restarted TDF therapy
Overall Number of Participants Analyzed 21 8
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 21 participants 0 participants
4.8
Week 4 Number Analyzed 20 participants 0 participants
0
Week 6 Number Analyzed 20 participants 0 participants
35.0
Week 8 Number Analyzed 20 participants 0 participants
60.0
Week 10 Number Analyzed 20 participants 0 participants
70.0
Week 12 Number Analyzed 19 participants 2 participants
42.1 100.0
Week 16 Number Analyzed 19 participants 2 participants
26.3 100.0
Week 20 Number Analyzed 17 participants 2 participants
11.8 100.0
Week 24 Number Analyzed 18 participants 2 participants
16.7 50.0
Week 28 Number Analyzed 17 participants 3 participants
11.8 33.3
Week 32 Number Analyzed 15 participants 3 participants
13.3 0
Week 36 Number Analyzed 17 participants 2 participants
11.8 0
Week 40 Number Analyzed 17 participants 3 participants
23.5 0
Week 44 Number Analyzed 17 participants 1 participants
11.8 0
Week 48 Number Analyzed 18 participants 3 participants
16.7 0
Week 60 Number Analyzed 18 participants 3 participants
22.2 0
Week 72 Number Analyzed 17 participants 5 participants
11.8 40
Week 84 Number Analyzed 16 participants 5 participants
18.8 0
Week 96 Number Analyzed 16 participants 5 participants
12.5 0
Week 108 Number Analyzed 16 participants 5 participants
18.8 0
Week 120 Number Analyzed 15 participants 7 participants
20.0 14.3
Week 132 Number Analyzed 12 participants 7 participants
0 28.6
Week 144 Number Analyzed 13 participants 8 participants
15.4 0
7.Secondary Outcome
Title Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms
Hide Description HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HBsAg Loss and Seroconversion Full Analysis Set
Arm/Group Title Stop TDF Continue TDF
Hide Arm/Group Description:
Participants stopped TDF monotherapy at baseline.
Participants continued TDF monotherapy 300 mg once daily.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.172
(0.058 to 0.446)
0 [1] 
(NA to NA)
[1]
No participants in the Continue TDF group had HBsAg loss
Time Frame Up to 144 weeks
Adverse Event Reporting Description
  • Safety Analysis Set
  • TDF-emergent Events (Restart TDF and Continue TDF): events began on/after date of TDF restart until last dose day for subjects who restarted TDF in the Stop TDF group and on/after Study Day 1 until last dose day for subjects in the Continue TDF group
  • Termination-emergent Events (TDF-Free): events began on/after Study Day 1 for the Stop TDF group until last study day for subjects who did not restart TDF and prior to date of restart for subjects who restarted TDF
 
Arm/Group Title Stop TDF (TDF-Free) [Termination Emergent] Re-start TDF [TDF Emergent] Continue TDF [TDF Emergent]
Hide Arm/Group Description Participants stopped TDF monotherapy at baseline. Stop TDF participants who restarted TDF therapy. Participants continued TDF monotherapy 300 mg once daily.
All-Cause Mortality
Stop TDF (TDF-Free) [Termination Emergent] Re-start TDF [TDF Emergent] Continue TDF [TDF Emergent]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/8 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Stop TDF (TDF-Free) [Termination Emergent] Re-start TDF [TDF Emergent] Continue TDF [TDF Emergent]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/21 (19.05%)   1/8 (12.50%)   3/21 (14.29%) 
Cardiac disorders       
Acute coronary syndrome  1  0/21 (0.00%)  0/8 (0.00%)  1/21 (4.76%) 
General disorders       
Surgical failure  1  0/21 (0.00%)  1/8 (12.50%)  0/21 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis  1  0/21 (0.00%)  0/8 (0.00%)  1/21 (4.76%) 
Infections and infestations       
Appendicitis  1  1/21 (4.76%)  0/8 (0.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications       
Facial bones fracture  1  0/21 (0.00%)  0/8 (0.00%)  1/21 (4.76%) 
Limb traumatic amputation  1  1/21 (4.76%)  0/8 (0.00%)  0/21 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  2/21 (9.52%)  0/8 (0.00%)  0/21 (0.00%) 
Psychiatric disorders       
Depression  1  0/21 (0.00%)  0/8 (0.00%)  1/21 (4.76%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stop TDF (TDF-Free) [Termination Emergent] Re-start TDF [TDF Emergent] Continue TDF [TDF Emergent]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/21 (80.95%)   6/8 (75.00%)   16/21 (76.19%) 
Ear and labyrinth disorders       
Vertigo  1  0/21 (0.00%)  0/8 (0.00%)  2/21 (9.52%) 
Gastrointestinal disorders       
Abdominal pain  1  4/21 (19.05%)  0/8 (0.00%)  0/21 (0.00%) 
Abdominal pain upper  1  2/21 (9.52%)  0/8 (0.00%)  0/21 (0.00%) 
Diarrhoea  1  2/21 (9.52%)  1/8 (12.50%)  1/21 (4.76%) 
Dyspepsia  1  2/21 (9.52%)  1/8 (12.50%)  0/21 (0.00%) 
Gastritis  1  0/21 (0.00%)  1/8 (12.50%)  0/21 (0.00%) 
Haemorrhoids  1  2/21 (9.52%)  0/8 (0.00%)  0/21 (0.00%) 
General disorders       
Fatigue  1  4/21 (19.05%)  2/8 (25.00%)  2/21 (9.52%) 
Influenza like illness  1  0/21 (0.00%)  1/8 (12.50%)  1/21 (4.76%) 
Immune system disorders       
Seasonal allergy  1  2/21 (9.52%)  0/8 (0.00%)  0/21 (0.00%) 
Infections and infestations       
Bronchitis  1  2/21 (9.52%)  0/8 (0.00%)  2/21 (9.52%) 
Gastroenteritis  1  2/21 (9.52%)  0/8 (0.00%)  2/21 (9.52%) 
Nasopharyngitis  1  11/21 (52.38%)  1/8 (12.50%)  6/21 (28.57%) 
Sinusitis  1  0/21 (0.00%)  1/8 (12.50%)  1/21 (4.76%) 
Investigations       
Alanine aminotransferase increased  1  4/21 (19.05%)  0/8 (0.00%)  0/21 (0.00%) 
Aspartate aminotransferase increased  1  2/21 (9.52%)  0/8 (0.00%)  0/21 (0.00%) 
Blood creatine phosphokinase increased  1  2/21 (9.52%)  0/8 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/21 (0.00%)  1/8 (12.50%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/21 (0.00%)  0/8 (0.00%)  2/21 (9.52%) 
Back pain  1  4/21 (19.05%)  1/8 (12.50%)  1/21 (4.76%) 
Musculoskeletal pain  1  0/21 (0.00%)  1/8 (12.50%)  2/21 (9.52%) 
Myalgia  1  0/21 (0.00%)  0/8 (0.00%)  2/21 (9.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  0/21 (0.00%)  1/8 (12.50%)  0/21 (0.00%) 
Keratoacanthoma  1  1/21 (4.76%)  1/8 (12.50%)  0/21 (0.00%) 
Nervous system disorders       
Headache  1  5/21 (23.81%)  1/8 (12.50%)  3/21 (14.29%) 
Renal and urinary disorders       
Haematuria  1  0/21 (0.00%)  1/8 (12.50%)  0/21 (0.00%) 
Renal colic  1  0/21 (0.00%)  1/8 (12.50%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/21 (9.52%)  0/8 (0.00%)  0/21 (0.00%) 
Oropharyngeal pain  1  1/21 (4.76%)  1/8 (12.50%)  1/21 (4.76%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  2/21 (9.52%)  0/8 (0.00%)  0/21 (0.00%) 
Vascular disorders       
Hypertension  1  2/21 (9.52%)  0/8 (0.00%)  4/21 (19.05%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Publications of Results:
Berg T, Schott E, Felten G, Eisenbach C, Welzel TM, Warger T, et al. Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-Negative CHB: Two Cases From an Ongoing Randomized, Controlled Trial [Poster Number P47] The Viral Hepatitis Congress; 2012 September 7-9; Frankfurt am Main, Germany.
Berg T, Simon K-G, Mauss S, Schott E, Heyne R, Klass D, et al. Stopping Tenofovir Disoproxil Fumarate Treatment After Long-Term Virologic Suppression in HBeAg-Negative CHB: Week 48 Interim Results From an Ongoing Randomized, Controlled Trial ("FINITE CHB") [Presentation P119]. The European Association for the Study of the Liver (EASL). 50th International Liver Congress; 2015 22-26 April; Vienna, Austria.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01320943     History of Changes
Other Study ID Numbers: GS-EU-174-0160
2010-021925-12 ( EudraCT Number )
First Submitted: March 9, 2011
First Posted: March 23, 2011
Results First Submitted: July 27, 2017
Results First Posted: August 29, 2017
Last Update Posted: August 29, 2017