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Trial record 36 of 221 for:    "Hepatitis B" | "Tenofovir"

Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

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ClinicalTrials.gov Identifier: NCT01063036
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : February 13, 2014
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis B
Interventions Drug: Entecavir
Drug: Tenofovir
Enrollment 144
Recruitment Details Study initiated 17 May 2010; Week 48 Primary Endpoint 27 November 2012; Week 96 Study Completed18 February 2014. Participants with chronic Hepatitis B with surface antigen (HBsAg) who have been currently treated and experienced treatment failure were enrolled.
Pre-assignment Details 144 enrolled; 92 treated. Reasons for 52 never treated: physical/laboratory test findings 30; not in target population 21; no signed consent 7; medical history/concurrent disease 2; other exclusion criteria 1; unknown 3.
Arm/Group Title Entecavir + Tenofovir
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Entecavir (ETV) : Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Period Title: Participants Treated With Study Drug
Started 92
Completed 86
Not Completed 6
Reason Not Completed
Adverse Event             1
Protocol Violation             1
Withdrawal by Subject             2
Lost to Follow-up             1
Pregnancy             1
Period Title: Post Dosing Follow-up Through 24 Weeks
Started 85 [1]
Completed 46
Not Completed 39
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             6
Alternative therapy started             32
[1]
2 included did not complete treatment; 3 completed treatment but not included (lost to follow-up).
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
All participants who were treated with study drug.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 92 participants
42.0
(18 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
23
  25.0%
Male
69
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
France 10
Poland 32
Romania 20
Germany 23
Netherlands 6
Italy 1
HBV DNA by PCR (log10 IU/mL)   [1] 
Median (Full Range)
Unit of measure:  Log10 IU/mL
Number Analyzed 92 participants
3.674
(1.45 to 9.30)
[1]
Measure Description: Hepatitis B virus deoxyribonucleic acid (HBV DNA) by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in log 10 international units per milliliter (IU/mL), with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.
Baseline Hepatitis B e Antigen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
Positive for Hepatitis B e antigen 56
Negative for Hepatitis B e antigen 34
missing Hepatitis B e antigen test 2
Baseline Hepatitis B e Antibody  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
Positive for Hepatitis B e antibody 32
Negative for Hepatitis B e antibody 56
Intermediate Hepatitis B e antibody 2
missing Hepatitis B e antibody test 2
Baseline Hepatitis B Surface Antigen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
Positive for Hepatitis B Surface Antigen 92
Negative for Hepatitis B Surface Antigen 0
Baseline HBV Subtype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
HBV Subtype A 21
HBV Subtype B 2
HBV Subtype C 1
HBV Subtype D 35
HBV Subtype E 4
HBV Subtype G 1
HBV Subtype H 1
HBV Subtype Indeterminate 3
Insufficient HBV DNA 23
Missing HBV DNA test 1
Treatment Failure Prior to Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
Primary Non-Response 9
Virological Breakthrough 30
Partial Virological Breakthrough 52
Missing 1
1.Primary Outcome
Title Percentage of Participants With a Virologic Response at Week 48 - Treated Population
Hide Description Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were analyzed (NC = F). An exact binomial 95% confidence interval was constructed.
Arm/Group Title Entecavir + Tenofovir
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Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.1
(66.1 to 84.4)
2.Secondary Outcome
Title Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population
Hide Description Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 24, Week 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.
Time Frame Week 24, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were analyzed at Weeks 24 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24 (n=92)
64.1
(53.5 to 73.9)
Week 96 (n=92)
84.8
(75.8 to 91.4)
3.Secondary Outcome
Title Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population
Hide Description HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in log 10 IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. Baseline was Day 1, prior to study drug administration.
Time Frame Baseline to Weeks 12, 24, 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with results at both baseline and on-treatment were analyzed. n=Number of treated participants with results at baseline and Week 12, Week 24, Week 48 and Week 96.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 12 (n=89) -2.230  (1.5339)
Week 24 (n=89) -2.581  (1.8019)
Week 48 (n=88) -2.829  (2.0537)
Week 96 (n=84) -2.965  (2.1431)
4.Secondary Outcome
Title Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population
Hide Description HBV DNA less than (<) LLD (6 IU/mL) was defined/measured by the COBAS(REGISTERED) TaqMan HPS assay at Weeks 24, 48, and 96. Percentage was calculated as number of participants with HBV DNA < LLD at Weeks 24, 48, 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F).
Time Frame Weeks 24, 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24 (n=92)
12.0
(6.1 to 20.4)
Week 48 (n=92)
18.5
(11.1 to 27.9)
Week 96 (n=92)
16.3
(9.4 to 25.5)
5.Secondary Outcome
Title Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline
Hide Description Loss of HBeAg was defined as being HBeAg-negative at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used for HBeAg was DiaSorin - Anti HBe enzyme immunoassay kit – procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBeAg loss at Weeks 24 and 48 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.
Time Frame Baseline to Weeks 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24 (n=56)
3.6
(0.4 to 12.3)
Week 48 (n=56)
5.4
(1.1 to 14.9)
Week 96 (n=56)
8.9
(3.0 to 19.6)
6.Secondary Outcome
Title Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline
Hide Description HBe seroconversion was defined as being both HBeAg-negative and HBeAb-positive at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBe seroconversion at Weeks 24, 48, and 96 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.
Time Frame Baseline, Weeks 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24 (n=56)
3.6
(0.4 to 12.3)
Week 48 (n=56)
3.6
(0.4 to 12.3)
Week 96 (n=56)
1.8
(0.0 to 9.6)
7.Secondary Outcome
Title Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline
Hide Description Loss of HBsAg was defined as being HBsAg-negative at Weeks 24, 48, 96 in those participants who had been HBsAg-positive at baseline. The method used: Immunoassay – ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma (potassium ethylene diamine tetraacetic acid, lithium or sodium heparinized). Percentage calculated as number of participants with a HBsAg loss at Weeks 24, 48, and 96 divided by the number of treated participants who were HBsAg-positive at baseline (participants were not enrolled into the study unless they were positive for HBsAg). Treated participants (HBsAg-positive at baseline) were evaluated using NC=F. Baseline was Day 1, before start of study drug.
Time Frame Baseline, Weeks 24, 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48, and 96 (NC = F). An exact binomial 95% Confidence Interval was constructed.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24 (n=92)
1.1
(0.0 to 5.9)
Week 48 (n=92)
0 [1] 
(NA to NA)
Week 96 (n=92)
2.2
(0.3 to 7.6)
[1]
Confidence interval was not performed because the number of participants at Week 48 was 0.
8.Secondary Outcome
Title Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline
Hide Description HBsAg seroconversion was defined as being both HBsAg-negative and HBsAb-positive at Weeks 24, 48, and 96 in those participants who had been HBsAg-positive at baseline. Percentage was calculated as number of participants with HBs seroconversion at Weeks 24 and 48 divided by the number of treated participants who were HBsAg-positive at baseline. Positive result for HBsAg was one of the inclusion criteria. Treated participants (HBsAg positive at baseline) were evaluated using NC=F. The method used was an Immunoassay testing – ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma [potassium ethylenediaminetetraacetic acid (EDTA), lithium or sodium heparinized]. Baseline was Day 1, before start of study drug.
Time Frame Baseline, Weeks 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24 (n=92)
1.1
(0.0 to 5.9)
Week 48 (n=92)
0 [1] 
(NA to NA)
Week 96 (n=92)
1.1
(0.0 to 5.9)
[1]
CI was not performed because the number of participants with HBsAg loss at Week 48 was 0.
9.Secondary Outcome
Title Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. On-treatment = on Day 1 through last dose of study therapy + 5 days.
Time Frame Day 1 to last dose of study drug plus 5 days; up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants were analyzed.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
Treatment emergent SAE 6
Discontinuation of treatment due to AE 1
10.Secondary Outcome
Title Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population
Hide Description Testing of HBV genotype was performed at baseline for all treated patients and for participants at Weeks 48 and 96 with primary non-response or virologic breakthrough. Emergent genotypic resistance to study drugs was defined as follows: Emergent = not detected at baseline; entecavir (ETV) resistance (ETVr): participant’s sample was to have rtM204V/I/S and any substitution at rtT184, rtS202, or rtM250; tenofovir (TDF) resistance (TDFr) which was based on adefovir (ADV)-mutations: participant’s sample was to have rtA181T/V, rtN236T, or (rtA194T and rtM204V/I/S). Primary non-response was defined as < 1 log10 decrease in HBV DNA from baseline on treatment at or after Week 12. Virologic breakthrough was defined as ≥ 1 log10 increase in HBV DNA over nadir on treatment, either confirmed or last on-treatment followed by discontinuation of study therapy.
Time Frame Baseline to Weeks 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who met resistance testing criteria (primary non-response or virologic breakthrough) and were tested for resistance to both study drugs were analyzed. n = number of participants analyzed at Weeks 48 and 96.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Week 48 (n=5) 0
Week 96 (n=7) 0
11.Secondary Outcome
Title Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population
Hide Description Selected criteria presented in each category. Upper limit of normal among all laboratory ranges (ULN); Baseline (BL); alanine transaminase (ALT); milligram per deciliter (mg/dL); milliliters per minute (mL/min); greater than (>);greater than, equal to (>=); less than (<). Creatinine data presented below were confirmed, ie, at least 2 consecutive values. On-treatment = after Day 1 through last dose of study therapy + 5 days.
Time Frame Day 1 to last dose of study drug plus 5 days; up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
N=treated participants with on-treatment laboratory test results.
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description:

Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks

Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: participants
ALT > 2*Baseline(N=90) 9
ALT > 3*Baseline(N=90) 2
Total bilirubin >2*Baseline (N=90) 11
Total bilirubin >3*Baseline (N=90) 3
Lipase > 3*Baseline (N=90) 4
Creatinine increase from BL >= 20%(N=91) 4
Creatinine >1.5 mg/dL (N=91) 2
Creatinine clearance < 50 mL/min (N=91) 1
Phosphate < 2.0 mg/dL (N=90) 2
Phosphate < 2.3 mg/dL (N=90) 8
Time Frame Day 1 up to 96 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Entecavir + Tenofovir
Hide Arm/Group Description Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks
All-Cause Mortality
Entecavir + Tenofovir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Entecavir + Tenofovir
Affected / at Risk (%)
Total   6/92 (6.52%) 
Eye disorders   
Cataract  1  1/92 (1.09%) 
Gastrointestinal disorders   
Inguinal hernia  1  1/92 (1.09%) 
Haemorrhoids  1  1/92 (1.09%) 
Infections and infestations   
Appendicitis  1  1/92 (1.09%) 
Injury, poisoning and procedural complications   
Radius fracture  1  1/92 (1.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatocellular carcinoma  1  2/92 (2.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Entecavir + Tenofovir
Affected / at Risk (%)
Total   42/92 (45.65%) 
Gastrointestinal disorders   
Nausea  1  8/92 (8.70%) 
Abdominal pain upper  1  5/92 (5.43%) 
Dyspepsia  1  7/92 (7.61%) 
Diarrhoea  1  6/92 (6.52%) 
General disorders   
Asthenia  1  6/92 (6.52%) 
Fatigue  1  9/92 (9.78%) 
Infections and infestations   
Bronchitis  1  6/92 (6.52%) 
Nasopharyngitis  1  11/92 (11.96%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/92 (7.61%) 
Nervous system disorders   
Dizziness  1  5/92 (5.43%) 
Headache  1  6/92 (6.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01063036     History of Changes
Other Study ID Numbers: AI463-203
2009-015705-40 ( EudraCT Number )
First Submitted: February 3, 2010
First Posted: February 5, 2010
Results First Submitted: November 5, 2013
Results First Posted: February 13, 2014
Last Update Posted: December 15, 2014