Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01379508
Collaborator
(none)
241
34
2
56.7
7.1
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients. The data from the study should allow for the validation of the Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative CHB patients. As part of a post-approval commitment to the European Health Authorities, the data will also be used to provide an optimized clinical treatment strategy for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from the study will contribute to a better scientific understanding, disease management and treatment of HBeAg negative CHB patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
241 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
OPTIMA: A Randomized, Open-label, 156-week Treatment Study to Evaluate the Efficacy and Safety of Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept
Actual Study Start Date
:
Mar 21, 2011
Actual Primary Completion Date
:
Dec 10, 2015
Actual Study Completion Date
:
Dec 10, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: telbivudine telbivudine 600 mg tablet orally (p.o.) once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with tenofovir 300 mg tablets p.o. once daily for the remaining weeks of treatment. The investigator was to initiate tenofovir add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA < 300 copies/mL at Week 24 were to continue to receive telbivudine monotherapy |
Drug: telbivudine
600 mg film-coated tablets taken as 600 mg once daily
Other Names:
|
| Active Comparator: tenofovir tenofovir 300 mg tablets p.o. once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with telbivudine 600 mg tablet p.o. once daily for the remaining weeks of treatment. The investigator was to initiate telbivudine add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA < 300 copies/mL at Week 24 were to continue to receive tenofovir monotherapy |
Drug: tenofovir disoproxil fumarate
300 mg tablets taken as 300 mg once daily
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) - [week 52]
The primary objective of the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2). For the "treating missing as failure" analysis, patients who came for their primary endpoint Week 52 visit within the ± 7-day window but not on the exact designated day of the visit were treated as "missing data."
Secondary Outcome Measures
- Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT) [week 24, 52, 104]
To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL), ALT normalization, HBsAg loss, HBsAg conversion, virologic breakthrough (VB) at study visit, cumulative VB by study defined study period, cumulative treatment-emergent resistance
- Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT) [156 weeks]
To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week156, ALT normalization, HBsAg loss, development of HBsAg conversion , cumulative tx emergent resistance, HBV DNA <300 copies/mL with HBV DNA <7 log at Baseline
- eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study [Baseline, 24 weeks, 52 weeks, 104 weeks, 156 weeks]
eGFR changes were calculated using the Modification of Diet in Renal Disease (MDRD) formula: GFR = 186 x (sCr)^(-1.154) x (age)^-0.203 with Female: Multiply GFR by 0.742; Black: Multiply GFR by 1.210. sCr is Serum Creatinine in mg/dl (measured at each scheduled visit). Age in years at visit (=[sCr sample collection date -Date of birth]/365.25). Weight in kilograms, as measured at the visit or the closest previous visit Safety population.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Male or female, at least 18 years of age
Documented compensated HBeAg negative CHB defined by all of the following:
-
Detectable serum HBsAg at screening visit and at least 6 months prior;
-
HBeAg negative at the screening visit with positive HBeAb;
-
Serum HBV DNA > 2000 IU/mL Serum ALT level > 1×ULN and <10×ULN at screening visit; patient with normal ALT ≤1xULN at screening are eligible, with moderate liver inflammation or fibrosis, complensated liver sirrhosis, ALT level >1xULN wtihin last 6 months
Exclusion Criteria:
-
Co-infected with HCV, HDV or HIV.
-
Received treatment of nucleoside or nucleotide drugs at any time
-
Received IFN or other immunomodulatory treatment within six months before Screening
-
Pregnant or nursing (lactating) women
-
Clinical signs/symptoms of hepatic decompensation
-
History of myopathy, myositis or persistent muscle weakness
-
history of clinical and laboratory evidence of chronic renal insufficency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Innsbruck | Austria | A-6020 | |
| 2 | Novartis Investigative Site | Wien | Austria | 1090 | |
| 3 | Novartis Investigative Site | Sofia | Bulgaria | 1407 | |
| 4 | Novartis Investigative Site | Sofia | Bulgaria | 1413 | |
| 5 | Novartis Investigative Site | Sofia | Bulgaria | 1431 | |
| 6 | Novartis Investigative Site | Sofia | Bulgaria | 1527 | |
| 7 | Novartis Investigative Site | Varna | Bulgaria | 9010 | |
| 8 | Novartis Investigative Site | Frankfurt | Germany | 60590 | |
| 9 | Novartis Investigative Site | Freiburg | Germany | 79106 | |
| 10 | Novartis Investigative Site | Hamburg | Germany | 20099 | |
| 11 | Novartis Investigative Site | Hannover | Germany | 30625 | |
| 12 | Novartis Investigative Site | Herne | Germany | 44623 | |
| 13 | Novartis Investigative Site | Leipzig | Germany | 04103 | |
| 14 | Novartis Investigative Site | Wurzburg | Germany | 97080 | |
| 15 | Novartis Investigative Site | Alexandroupolis | Evros | Greece | 681 00 |
| 16 | Novartis Investigative Site | Athens | GR | Greece | 115 21 |
| 17 | Novartis Investigative Site | Thessaloniki | GR | Greece | 546 42 |
| 18 | Novartis Investigative Site | Athens | Greece | 115 27 | |
| 19 | Novartis Investigative Site | Caserta | CE | Italy | 81100 |
| 20 | Novartis Investigative Site | Moscow | Russian Federation | 111123 | |
| 21 | Novartis Investigative Site | Moscow | Russian Federation | 119333 | |
| 22 | Novartis Investigative Site | Moscow | Russian Federation | 119992 | |
| 23 | Novartis Investigative Site | Moscow | Russian Federation | 127473 | |
| 24 | Novartis Investigative Site | Moscow | Russian Federation | 129110 | |
| 25 | Novartis Investigative Site | Moscow | Russian Federation | ||
| 26 | Novartis Investigative Site | Saint-Petersburg | Russian Federation | 194044 | |
| 27 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08003 |
| 28 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08035 |
| 29 | Novartis Investigative Site | Tarragona | Cataluña | Spain | 43005 |
| 30 | Novartis Investigative Site | Majadahonda | Madrid | Spain | 28222 |
| 31 | Novartis Investigative Site | Istanbul | TUR | Turkey | 34098 |
| 32 | Novartis Investigative Site | Diyarbakir | Turkey | 21280 | |
| 33 | Novartis Investigative Site | Izmir | Turkey | 35040 | |
| 34 | Novartis Investigative Site | Trabzon | Turkey | 61080 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01379508
Other Study ID Numbers:
- CLDT600A2409
- 2007-000180-13
First Posted:
Jun 23, 2011
Last Update Posted:
Nov 5, 2018
Last Verified:
Mar 1, 2018
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LdT Mono at Week 24 | LdT+TDF at Week 24 | TDF Mono at Week 24 | TDF + LdT at Week 24 |
|---|---|---|---|---|
| Arm/Group Description | Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily after Week 24 | Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24. | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. |
| Period Title: Treatment to Week 104 | ||||
| STARTED | 99 | 22 | 109 | 11 |
| Completed Wk 24 | 93 | 22 | 107 | 11 |
| Treatment Exposure ≥ 52 Weeks | 91 | 21 | 105 | 11 |
| COMPLETED | 80 | 19 | 96 | 11 |
| NOT COMPLETED | 19 | 3 | 13 | 0 |
| Period Title: Treatment to Week 104 | ||||
| STARTED | 64 | 17 | 79 | 10 |
| COMPLETED | 45 | 14 | 65 | 10 |
| NOT COMPLETED | 19 | 3 | 14 | 0 |
Baseline Characteristics
| Arm/Group Title | LdT Mono at Week 24 | LdT+TDF at Week 24 | TDF Mono at Week 24 | TDF + LdT at Week 24 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Patients who had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 continued to receive 600 mg telbivudine daily after Week 24 | Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24. | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. | Total of all reporting groups |
| Overall Participants | 99 | 22 | 109 | 11 | 241 |
| Age, Customized (Count of Participants) | |||||
| < 30 years |
17
17.2%
|
4
18.2%
|
18
16.5%
|
0
0%
|
39
16.2%
|
| Between 30 and 50 years |
56
56.6%
|
13
59.1%
|
59
54.1%
|
7
63.6%
|
135
56%
|
| > 50 years |
26
26.3%
|
5
22.7%
|
32
29.4%
|
4
36.4%
|
67
27.8%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
28
28.3%
|
7
31.8%
|
34
31.2%
|
4
36.4%
|
73
30.3%
|
| Male |
71
71.7%
|
15
68.2%
|
75
68.8%
|
7
63.6%
|
168
69.7%
|
| HBV DNA (log10 copies/mL)) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [log10 copies/mL)] |
5.887
(1.2862)
|
7.769
(1.2502)
|
5.838
(1.2464)
|
7.938
(1.0709)
|
5.887
(1.2862)
|
| HBV DNA levels < or ≥ 7 log 10 copies/mL at baseline. (Count of Participants) | |||||
| < 7 log 10 copies/mL |
81
81.8%
|
4
18.2%
|
83
76.1%
|
3
27.3%
|
171
71%
|
| ≥ 7 log 10 copies/mL |
18
18.2%
|
18
81.8%
|
26
23.9%
|
8
72.7%
|
70
29%
|
| Participants with alanine aminotransferase (ALT) - Multiples of upper limits of normal (ULN) (Count of Participants) | |||||
| ≤ 1 × ULN |
46
46.5%
|
3
13.6%
|
52
47.7%
|
4
36.4%
|
105
43.6%
|
| > 1 × - < 2 × ULN |
35
35.4%
|
7
31.8%
|
27
24.8%
|
5
45.5%
|
74
30.7%
|
| 2 × - < 5 × ULN |
13
13.1%
|
11
50%
|
26
23.9%
|
1
9.1%
|
51
21.2%
|
| 5 × or more ULN |
5
5.1%
|
1
4.5%
|
4
3.7%
|
1
9.1%
|
11
4.6%
|
| Participants with aspartate aminotransferase (AST) - Multiples of upper limits of normal (ULN) (Count of Participants) | |||||
| ≤ 1 × ULN |
70
70.7%
|
10
45.5%
|
69
63.3%
|
2
18.2%
|
151
62.7%
|
| > 1 × - < 2 × ULN |
14
14.1%
|
7
31.8%
|
23
21.1%
|
7
63.6%
|
51
21.2%
|
| 2 × - < 5 × ULN |
12
12.1%
|
4
18.2%
|
16
14.7%
|
1
9.1%
|
33
13.7%
|
| 5 × or more ULN |
3
3%
|
1
4.5%
|
1
0.9%
|
1
9.1%
|
6
2.5%
|
Outcome Measures
| Title | Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) - |
|---|---|
| Description | The primary objective of the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2). For the "treating missing as failure" analysis, patients who came for their primary endpoint Week 52 visit within the ± 7-day window but not on the exact designated day of the visit were treated as "missing data." |
| Time Frame | week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Roadmap intent-to-treat (rITT) population consisted of patients in the ITT population who did not discontinue before Wk 24 and did not receive add-on. The total of the mono and combination arms were analyzed. |
| Arm/Group Title | LdT Overall | TDF Overall |
|---|---|---|
| Arm/Group Description | Ldt Mono and LdT + TDF combined | TDF mono and TDF + LdT combined |
| Measure Participants | 113 | 117 |
| Missing DNA data at Wk 52=failure |
91.0
91.9%
|
95.0
431.8%
|
| Imputing +/- 7 days DNA for Wk 52 |
91.9
92.8%
|
95.0
431.8%
|
| Imputing LOCF DNA for Wk 52 |
95.4
96.4%
|
99.2
450.9%
|
| Imputing within +28d DNA for Wk 52 |
92.7
93.6%
|
95.0
431.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LdT Overall, TDF Overall |
|---|---|---|
| Comments | Missing DNA data at Wk 52=failure: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA < 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | -4 | |
| Confidence Interval |
(2-Sided) 95% -10.5 to 2.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | LdT Overall, TDF Overall |
|---|---|---|
| Comments | Imputing +/- 7 days DNA for Wk 52: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA < 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Noninferiority was derived if the lower limit of two-sided 95% CI for the difference was above the pre-determined non-inferiority margin (-10%). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | -3.1 | |
| Confidence Interval |
(2-Sided) 95% -9.4 to 3.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | LdT Overall, TDF Overall |
|---|---|---|
| Comments | Imputing LOCF DNA for wk 52: d/c for non response prior to Wk 52: Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with LOCF for other patients | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | -3.8 | |
| Confidence Interval |
(2-Sided) 95% -7.9 to 0.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | LdT Overall, TDF Overall |
|---|---|---|
| Comments | Imputing within +28d DNA for wk52: d/c for non response <28 days from Wk 52:Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with the earliest available assessment within the 28-day window starting from the scheduled Week 52 date for other patients (if no such assessment is available, treated as failure) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | -2.3 | |
| Confidence Interval |
(2-Sided) 95% -8.3 to 3.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT) |
|---|---|
| Description | To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL), ALT normalization, HBsAg loss, HBsAg conversion, virologic breakthrough (VB) at study visit, cumulative VB by study defined study period, cumulative treatment-emergent resistance |
| Time Frame | week 24, 52, 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Roadmap intent-to-treat (rITT) population was analyzed. |
| Arm/Group Title | LdT Mono at Week 24 | LdT+TDF at Week 24 | LdT Overall | TDF Mono at Week 24 | TDF + LdT at Week 24 | TDF Overall |
|---|---|---|---|---|---|---|
| Arm/Group Description | Patients who had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 continued to receive 600 mg telbivudine daily after Week 24 | Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24. | Ldt Mono and LdT + TDF combined | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. | TDF mono and TDF + LdT combined |
| Measure Participants | 92 | 21 | 113 | 106 | 11 | 117 |
| HBV DNA <300 Week 24 |
98.9
|
0.0
|
80.5
|
99.1
|
0
|
89.7
|
| HBV DNA <300 Week 104 |
69.6
|
76.2
|
70.8
|
74.5
|
81.8
|
75.2
|
| HBV DNA <300 Week 24 LOCF |
100.0
|
0
|
81.4
|
100.0
|
0
|
90.6
|
| HBV DNA <300 Wk104 LOCF |
92.4
|
100.0
|
93.8
|
99.1
|
100.0
|
99.1
|
| ALT Normalization Wk 52 |
84.0
|
83.3
|
83.8
|
82.5
|
85.7
|
82.8
|
| ALT Normalization Week 104 |
70.0
|
72.2
|
70.6
|
61.4
|
85.7
|
64.1
|
| ALT Normalization Wk 52 LOCF |
88.0
|
83.3
|
86.8
|
87.7
|
85.7
|
87.5
|
| ALT Normalization Wk 104 LOCF |
92.0
|
83.3
|
89.7
|
86.0
|
85.7
|
85.9
|
| HBsAg loss Week 52 |
0
|
0
|
0
|
0
|
0
|
0
|
| HBsAg loss Week 104 |
0
|
0
|
0
|
0
|
0
|
0
|
| HBsAg conversion Week 52 |
0
|
0
|
0
|
0
|
0
|
0
|
| HBsAg conversion Week 104 |
0
|
0
|
0
|
0
|
0
|
0
|
| Cum virol break BaseL to Wk 24 |
0
|
4.8
|
0.9
|
0
|
0
|
0
|
| Cum virol break Wk 24 to Wk 52 |
3.3
|
0
|
2.7
|
0
|
0
|
0
|
| Cum virol break Wk 52 to Wk 104 |
12.0
|
0
|
9.7
|
1.9
|
0
|
1.7
|
| Cum virol break BaseLto Wk 104 |
14.1
|
4.8
|
12.4
|
1.9
|
0
|
1.7
|
| Cum vir break BL to Wk24 LOCF |
0
|
4.8
|
0.9
|
0
|
0
|
0
|
| Cum virol break Wk 24 to Wk 52 LOCF |
3.3
|
0
|
2.7
|
0
|
0
|
0
|
| Cum virol break Wk52-Wk104 LOCF |
12.0
|
0
|
9.7
|
1.9
|
0
|
1.7
|
| Cum virol break BLto Wk 104 LOCF |
14.1
|
4.8
|
12.4
|
1.9
|
0
|
1.7
|
| Cum tx emergent resistance Wk 52 |
3.3
|
0
|
2.7
|
0
|
0
|
0
|
| Ccum tx emergent resistance Wk 104 |
9.2
|
0
|
7.4
|
0
|
0
|
0
|
| Cum tx emergent resist Wk52 LOCF |
3.3
|
0
|
2.7
|
0
|
0
|
0
|
| Cum tx emergent resist Wk 104 LOCF |
9.2
|
0
|
7.4
|
0
|
0
|
0
|
| <7 log at BL HBV DNA <300 Wk52 |
93.4
|
75.0
|
92.5
|
95.0
|
100.0
|
95.2
|
| <7 log HBV DNA <300 Wk104 |
68.4
|
50.0
|
67.5
|
76.3
|
66.7
|
75.9
|
| <7 log HBV DNA <300 Wk 52 LOCF |
97.4
|
100.0
|
97.5
|
100.0
|
100.0
|
100.0
|
| <7 log HBV DNA <300 Wk 104 LOCF |
92.1
|
100.0
|
92.5
|
98.8
|
100.0
|
98.8
|
| Title | Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT) |
|---|---|
| Description | To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week156, ALT normalization, HBsAg loss, development of HBsAg conversion , cumulative tx emergent resistance, HBV DNA <300 copies/mL with HBV DNA <7 log at Baseline |
| Time Frame | 156 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified ITT (mITT) population consisted of all patients in ITT population who were eligible and enrolled into the extension. |
| Arm/Group Title | LdT Mono at Week 24 | LdT+TDF at Week 24 | LdT Overall | TDF Mono at Week 24 | TDF + LdT at Week 24 | TDF Overall |
|---|---|---|---|---|---|---|
| Arm/Group Description | Patients who had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 continued to receive 600 mg telbivudine daily after Week 24 | Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24. | Ldt Mono and LdT + TDF combined | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. | TDF mono and TDF + LdT combined |
| Measure Participants | 62 | 17 | 79 | 79 | 10 | 89 |
| HBV DNA < 300 Week 156 |
17.7
17.9%
|
11.8
53.6%
|
16.5
15.1%
|
13.9
126.4%
|
20.0
8.3%
|
14.6
NaN
|
| HBV DNA < 300 Wk156 LOCF |
88.7
89.6%
|
100.0
454.5%
|
91.1
83.6%
|
100.0
909.1%
|
100.0
41.5%
|
100.00
NaN
|
| ALT normalization Wk 156 |
14.3
14.4%
|
6.7
30.5%
|
12.0
11%
|
10.5
95.5%
|
28.6
11.9%
|
13.3
NaN
|
| ALT normalization Wk 156 LOCF |
85.7
86.6%
|
93.3
424.1%
|
88.0
80.7%
|
86.8
789.1%
|
85.7
35.6%
|
86.7
NaN
|
| HBSAg loss/ seroconversion |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
| Cum VB Wk104-156 LOCF |
16.1
16.3%
|
0
0%
|
12.7
11.7%
|
1.3
11.8%
|
0
0%
|
1.1
NaN
|
| Cum VB BL to Wk 156 LOCF |
21.0
21.2%
|
0
0%
|
16.5
15.1%
|
1.3
11.8%
|
0
0%
|
1.1
NaN
|
| Cum tx emerg resist Week 156 LOCF |
14.0
14.1%
|
0
0%
|
10.8
9.9%
|
0
0%
|
0
0%
|
0
NaN
|
| HBV DNA < 300 Wk156 <7 log at BL |
17.6
17.8%
|
0
0%
|
16.7
15.3%
|
11.7
106.4%
|
50.0
20.7%
|
12.9
NaN
|
| HBV DNA <300 Wk156 <7 log LOCF |
88.2
89.1%
|
100.0
454.5%
|
88.9
81.6%
|
100.0
909.1%
|
100.0
41.5%
|
100.0
NaN
|
| Cum tx-emerg resist Wk156 <7log LOCF |
8.7
8.8%
|
0.0
0%
|
8.2
7.5%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
| Title | eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study |
|---|---|
| Description | eGFR changes were calculated using the Modification of Diet in Renal Disease (MDRD) formula: GFR = 186 x (sCr)^(-1.154) x (age)^-0.203 with Female: Multiply GFR by 0.742; Black: Multiply GFR by 1.210. sCr is Serum Creatinine in mg/dl (measured at each scheduled visit). Age in years at visit (=[sCr sample collection date -Date of birth]/365.25). Weight in kilograms, as measured at the visit or the closest previous visit Safety population. |
| Time Frame | Baseline, 24 weeks, 52 weeks, 104 weeks, 156 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population consisted of patients who received at least 1 dose of study drug and had 1 post-baseline safety assessment. Numbers in parentheses represent the number of participants who met the criteria for the measurement in the 2 LDT arms, LDT Overall, 2 TDF arms, TDF Overall, respectively |
| Arm/Group Title | LdT Mono at Week 24 | LdT+TDF at Week 24 | LdT Overall | TDF Mono at Week 24 | TDF + LdT at Week 24 | TDF Overall |
|---|---|---|---|---|---|---|
| Arm/Group Description | Patients who had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 continued to receive 600 mg telbivudine daily after Week 24 | Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24. | Ldt Mono and LdT + TDF combined | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. | TDF mono and TDF + LdT combined |
| Measure Participants | 98 | 22 | 120 | 109 | 11 | 120 |
| Week 24 change (97,22,119,108,11,119) |
1.43
(12.815)
|
-12.06
(14.394)
|
-1.07
(14.076)
|
-2.41
(14.885)
|
-7.17
(15.368)
|
-2.85
(14.928)
|
| Week 52 change(97,22,119,108,11,119) |
5.18
(18.842)
|
-6.80
(17.229)
|
2.96
(19.064)
|
-2.70
(18.636)
|
-8.39
(10.479)
|
-3.22
(18.082)
|
| Week 104 change(97,22,119,108,11,119) |
5.19
(16.583)
|
-5.77
(15.943)
|
3.16
(16.947)
|
-3.83
(15.157)
|
-8.69
(15.632)
|
-4.28
(15.200)
|
| Week 156 change(62,17,79,79,10,89) |
8.07
(16.777)
|
-10.89
(14.993)
|
3.99
(18.104)
|
-5.34
(13.393)
|
-6.67
(11.905)
|
-5.49
(13.178)
|
| Baseline actual(98,22,120,109,11,120) |
94.71
(16.422)
|
109.79
(19.560)
|
97.47
(17.936)
|
95.91
(16.396)
|
94.50
(17.558)
|
95.78
(16.433)
|
| Week 24 actual(97,22,119,108,11,119) |
96.43
(16.434)
|
97.73
(17.690)
|
96.67
(16.603)
|
93.61
(18.500)
|
87.33
(16.854)
|
93.03
(18.378)
|
| Week 52 actual(97,22,119,108,11,119) |
100.18
(20.257)
|
102.99
(19.425)
|
100.70
(20.054)
|
93.32
(18.880)
|
86.12
(14.233)
|
92.66
(18.569)
|
| Week 104 actual (97,22,119,108,11,119) |
100.20
(16.287)
|
104.02
(18.201)
|
100.90
(16.643)
|
92.19
(18.240)
|
85.81
(13.099)
|
91.60
(17.879)
|
| Week 156 actual(62,17,79,79,10,89) |
101.33
(18.505)
|
100.70
(20.029)
|
101.20
(18.712)
|
88.83
(16.773)
|
87.93
(13.280)
|
88.73
(16.355)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | LdT Mono at Week 24 | LdT + TDF at Week 24 | TDF Mono at Week 24 | TDF + LdT at Week 24 | ||||
| Arm/Group Description | LdT Mono at Week 24 | LdT + TDF at Week 24 | TDF Mono at Week 24 | TDF + LdT at Week 24 | ||||
All Cause Mortality |
||||||||
| LdT Mono at Week 24 | LdT + TDF at Week 24 | TDF Mono at Week 24 | TDF + LdT at Week 24 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| LdT Mono at Week 24 | LdT + TDF at Week 24 | TDF Mono at Week 24 | TDF + LdT at Week 24 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/98 (6.1%) | 5/22 (22.7%) | 11/109 (10.1%) | 2/11 (18.2%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/98 (0%) | 0/22 (0%) | 2/109 (1.8%) | 0/11 (0%) | ||||
| Gastroduodenitis | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Gastrooesophageal reflux disease | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Haemorrhoids | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| General disorders | ||||||||
| Fatigue | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Hepatobiliary disorders | ||||||||
| Bile duct stone | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Cholecystitis acute | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 0/11 (0%) | ||||
| Hepatic cirrhosis | 0/98 (0%) | 0/22 (0%) | 3/109 (2.8%) | 0/11 (0%) | ||||
| Jaundice cholestatic | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Infections and infestations | ||||||||
| Abdominal abscess | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Anal abscess | 1/98 (1%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Appendicitis | 0/98 (0%) | 1/22 (4.5%) | 0/109 (0%) | 0/11 (0%) | ||||
| Investigations | ||||||||
| Blood creatine phosphokinase increased | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Type 1 diabetes mellitus | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/98 (0%) | 1/22 (4.5%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Osteonecrosis | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 0/11 (0%) | ||||
| Spinal column stenosis | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Bladder cancer | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 0/11 (0%) | ||||
| Breast cancer | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Hepatocellular carcinoma | 2/98 (2%) | 0/22 (0%) | 3/109 (2.8%) | 0/11 (0%) | ||||
| Metastases to abdominal wall | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Metastasis | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Nervous system disorders | ||||||||
| Carpal tunnel syndrome | 0/98 (0%) | 1/22 (4.5%) | 0/109 (0%) | 0/11 (0%) | ||||
| Diabetic neuropathy | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Ischaemic stroke | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Psychiatric disorders | ||||||||
| Psychogenic pain disorder | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Acute kidney injury | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Calculus ureteric | 0/98 (0%) | 1/22 (4.5%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Hydronephrosis | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pneumothorax spontaneous | 0/98 (0%) | 1/22 (4.5%) | 0/109 (0%) | 0/11 (0%) | ||||
| Vascular disorders | ||||||||
| Arterial occlusive disease | 0/98 (0%) | 1/22 (4.5%) | 0/109 (0%) | 0/11 (0%) | ||||
| Thrombophlebitis | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 0/11 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| LdT Mono at Week 24 | LdT + TDF at Week 24 | TDF Mono at Week 24 | TDF + LdT at Week 24 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 60/98 (61.2%) | 15/22 (68.2%) | 56/109 (51.4%) | 8/11 (72.7%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 2/11 (18.2%) | ||||
| Leukopenia | 2/98 (2%) | 0/22 (0%) | 6/109 (5.5%) | 0/11 (0%) | ||||
| Thrombocytopenia | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Eye disorders | ||||||||
| Visual impairment | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/98 (0%) | 1/22 (4.5%) | 2/109 (1.8%) | 1/11 (9.1%) | ||||
| Abdominal pain upper | 6/98 (6.1%) | 0/22 (0%) | 5/109 (4.6%) | 3/11 (27.3%) | ||||
| Diarrhoea | 8/98 (8.2%) | 0/22 (0%) | 5/109 (4.6%) | 0/11 (0%) | ||||
| Dyspepsia | 3/98 (3.1%) | 0/22 (0%) | 5/109 (4.6%) | 1/11 (9.1%) | ||||
| Gastritis | 6/98 (6.1%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Gastrooesophageal reflux disease | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Nausea | 10/98 (10.2%) | 3/22 (13.6%) | 2/109 (1.8%) | 3/11 (27.3%) | ||||
| Toothache | 1/98 (1%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| General disorders | ||||||||
| Asthenia | 5/98 (5.1%) | 1/22 (4.5%) | 0/109 (0%) | 2/11 (18.2%) | ||||
| Fatigue | 5/98 (5.1%) | 1/22 (4.5%) | 8/109 (7.3%) | 0/11 (0%) | ||||
| Influenza like illness | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Oedema peripheral | 1/98 (1%) | 0/22 (0%) | 1/109 (0.9%) | 2/11 (18.2%) | ||||
| Pyrexia | 1/98 (1%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 1/98 (1%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Ear infection | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Influenza | 8/98 (8.2%) | 2/22 (9.1%) | 8/109 (7.3%) | 2/11 (18.2%) | ||||
| Nasopharyngitis | 7/98 (7.1%) | 2/22 (9.1%) | 8/109 (7.3%) | 1/11 (9.1%) | ||||
| Respiratory tract infection | 3/98 (3.1%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Rhinitis | 5/98 (5.1%) | 2/22 (9.1%) | 0/109 (0%) | 0/11 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Epicondylitis | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Laceration | 2/98 (2%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 5/98 (5.1%) | 0/22 (0%) | 5/109 (4.6%) | 1/11 (9.1%) | ||||
| Amylase increased | 1/98 (1%) | 2/22 (9.1%) | 0/109 (0%) | 0/11 (0%) | ||||
| Aspartate aminotransferase increased | 7/98 (7.1%) | 1/22 (4.5%) | 4/109 (3.7%) | 0/11 (0%) | ||||
| Blood creatine phosphokinase increased | 24/98 (24.5%) | 10/22 (45.5%) | 17/109 (15.6%) | 2/11 (18.2%) | ||||
| Blood phosphorus increased | 1/98 (1%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Hyperglycaemia | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Hypoalbuminaemia | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 3/98 (3.1%) | 3/22 (13.6%) | 8/109 (7.3%) | 2/11 (18.2%) | ||||
| Groin pain | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Intervertebral disc protrusion | 1/98 (1%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Myalgia | 10/98 (10.2%) | 2/22 (9.1%) | 2/109 (1.8%) | 1/11 (9.1%) | ||||
| Neck pain | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Osteoarthritis | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Pain in extremity | 4/98 (4.1%) | 0/22 (0%) | 1/109 (0.9%) | 2/11 (18.2%) | ||||
| Nervous system disorders | ||||||||
| Ataxia | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Headache | 17/98 (17.3%) | 3/22 (13.6%) | 16/109 (14.7%) | 2/11 (18.2%) | ||||
| Paraesthesia | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Psychiatric disorders | ||||||||
| Anxiety | 1/98 (1%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Depression | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 2/11 (18.2%) | ||||
| Insomnia | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Renal and urinary disorders | ||||||||
| Crystalluria | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Haematuria | 1/98 (1%) | 5/22 (22.7%) | 1/109 (0.9%) | 0/11 (0%) | ||||
| Nephroptosis | 0/98 (0%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 1/98 (1%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Rash | 2/98 (2%) | 0/22 (0%) | 0/109 (0%) | 1/11 (9.1%) | ||||
| Seborrhoeic dermatitis | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 7/98 (7.1%) | 4/22 (18.2%) | 5/109 (4.6%) | 0/11 (0%) | ||||
| Hypotension | 0/98 (0%) | 0/22 (0%) | 1/109 (0.9%) | 1/11 (9.1%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
| Name/Title | Clinical Disclosure Office |
|---|---|
| Organization | Novartis |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01379508
Other Study ID Numbers:
- CLDT600A2409
- 2007-000180-13
First Posted:
Jun 23, 2011
Last Update Posted:
Nov 5, 2018
Last Verified:
Mar 1, 2018