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A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)

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ClinicalTrials.gov Identifier: NCT01433978
Recruitment Status : Terminated (Study was terminated early due to significant enrollment challenges.)
First Posted : September 14, 2011
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Idiopathic Thrombocytopenic Purpura
Interventions Drug: Eltrombopag
Drug: Avatrombopag
Drug: Standard of care
Enrollment 24
Recruitment Details  
Pre-assignment Details One screen-failed participant was randomized into the study in error, but not dosed.
Arm/Group Title Eltrombopag (Core Study) Avatrombopag (Core Study) Avatrombopag (Open-label Extension Phase)
Hide Arm/Group Description Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug. Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug. Participants who met the eligibility requirements for the Open-label Extension (OLE) Phase or who discontinued the Core Study early because of lack of treatment effect were eligible to continue into the OLE Phase for up to 104 weeks of open-label avatrombopag therapy. Participants entering the OLE from the Core Study received a starting dose of open-label avatrombopag that was determined by the last dose of study drug at the End of Treatment (EOT) Visit (Visit 22) of the Core Study. Participants who discontinued the Core Study early because of lack of treatment effect and entered the OLE received open-label avatrombopag at a starting dose of 20 mg once daily of open-label avatrombopag.
Period Title: Core Study
Started 11 12 0
Completed 0 1 0
Not Completed 11 11 0
Reason Not Completed
Adverse Event, Non-Fatal             0             1             0
Lack of Efficacy             5             1             0
Study Terminated by Sponsor             6             9             0
Period Title: Extension Phase
Started 0 0 6
Completed 0 0 0
Not Completed 0 0 6
Reason Not Completed
Adverse Event, Non-Fatal             0             0             1
Lack of Efficacy             0             0             1
Study Terminated by Sponsor             0             0             4
Arm/Group Title Eltrombopag (Core Study) Avatrombopag (Core Study) Total
Hide Arm/Group Description Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug. Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug. Total of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least one dose of study treatment and at least one postbaseline safety assessment.
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 23 participants
45.4  (20.09) 50.8  (23.04) 48.2  (21.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
7
  63.6%
7
  58.3%
14
  60.9%
Male
4
  36.4%
5
  41.7%
9
  39.1%
1.Primary Outcome
Title Change From Baseline in Local Platelet Count for the 6 Month Treatment Period
Hide Description Platelet responses to avatrombopag was evaluated using the platelet counts determined at local clinical laboratories. Only participants with non-missing data at both baseline and the relevant post-baseline visit are included in the change from baseline summary statistics. Standard deviation is not applicable for some of the categories, from Visit 14 to Visit 22, as the number of participants analyzed for that visit was 1 individual.
Time Frame Day 5, Day 8, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 19, Week 20, Week 22, Week 23, Week 24, Week 25, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all participants who were randomized into the study. Only participants with non-missing data at both baseline and the relevant post-baseline visit are included in the change from baseline summary statistics.
Arm/Group Title Eltrombopag (Core Study) Avatrombopag (Core Study)
Hide Arm/Group Description:
Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug.
Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug.
Overall Number of Participants Analyzed 11 12
Geometric Mean (Standard Deviation)
Unit of Measure: cells x 10^9/L
Visit 3 (Day 5) Number Analyzed 10 participants 10 participants
8.60  (17.312) 12.85  (16.054)
Visit 4 (Day 8) Number Analyzed 11 participants 11 participants
32.50  (44.519) 47.00  (59.690)
Visit 5 (Week 2) Number Analyzed 11 participants 12 participants
73.41  (79.885) 171.71  (201.736)
Visit 6 (Week 3) Number Analyzed 10 participants 12 participants
67.20  (95.536) 114.21  (117.172)
Visit 7 (Week 4) Number Analyzed 9 participants 12 participants
28.72  (38.437) 108.79  (217.036)
Visit 8 (Week 6) Number Analyzed 7 participants 11 participants
57.21  (57.718) 150.68  (134.902)
Visit 9 (Week 8) Number Analyzed 4 participants 8 participants
67.25  (46.055) 121.31  (149.040)
Visit 10 (Week 10) Number Analyzed 3 participants 6 participants
92.67  (34.649) 126.25  (90.602)
Visit 11 (Week 12) Number Analyzed 3 participants 5 participants
87.33  (72.616) 185.10  (115.841)
Visit 12 (Week 14 ) Number Analyzed 3 participants 4 participants
104.33  (77.114) 159.38  (116.746)
Visit 13 (Week 16) Number Analyzed 2 participants 4 participants
47.75  (2.475) 123.88  (124.474)
Visit 14 (Week 18) Number Analyzed 1 participants 2 participants
107.50 [1]   (NA) 46.50  (53.740)
Visit 15 (Week 19) Number Analyzed 1 participants 2 participants
13.50 [1]   (NA) 29.50  (22.627)
Visit 16 (Week 20) Number Analyzed 0 participants 1 participants
50.50 [1]   (NA)
Visit 18 (Week 22) Number Analyzed 0 participants 1 participants
75.50 [1]   (NA)
Visit 19 (Week 23) Number Analyzed 0 participants 1 participants
104.50 [1]   (NA)
Visit 20 (Week 24) Number Analyzed 0 participants 1 participants
106.50 [1]   (NA)
Visit 21 (Week 25) Number Analyzed 0 participants 1 participants
120.50 [1]   (NA)
Visit 22 (Week 26) Number Analyzed 0 participants 1 participants
58.50 [1]   (NA)
[1]
Standard deviation is not applicable.
Time Frame Up to 34 Weeks in the Core Study (including Titration, Treatment, Dose Taper, and Follow-up for those that did not enter the Extension Phase) and up to 112 weeks in the Extension Phase (including Conversion, Maintenance, Dose Taper, and Follow-up).
Adverse Event Reporting Description Treatment emergent adverse events were collected. Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE SAS: All participants who received at least 1 dose of avatrombopag (either in the Core or Extension Phase) and had a postdose safety assessment.
 
Arm/Group Title Eltrombopag (Core Study) Avatrombopag (Core Study) Avatrombopag (Extension Phase)
Hide Arm/Group Description Eltrombopag was administered orally as 25 mg, 50 mg, or 75 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 50 mg eltrombopag once daily and they were allowed to have their dose titrated up (maximum dose of 75 mg eltrombopag) or down (minimum dose of 25 mg eltrombopag) depending on their response to study drug. Avatrombopag was administered orally as 5 mg, 10 mg, 20 mg, 30 mg or 40 mg in a flexible dose design for 26 weeks. Participants received blinded therapy at a starting dose of 20 mg avatrombopag, once daily and they were allowed to have their dose titrated up (maximum dose of 40 mg avatrombopag) or down (minimum dose of 5 mg avatrombopag) depending on their response to study drug. Participants who met the eligibility requirements for the Open-label Extension (OLE) Phase or who discontinued the Core Study early because of lack of treatment effect were eligible to continue into the OLE Phase for up to 104 weeks of open-label avatrombopag therapy. Participants entering the OLE from the Core Study received a starting dose of open-label avatrombopag that was determined by the last dose of study drug at the End of Treatment (EOT) Visit (Visit 22) of the Core Study. Participants who discontinued the Core Study early because of lack of treatment effect and entered the OLE received open-label avatrombopag at a starting dose of 20 mg once daily of open-label avatrombopag.
All-Cause Mortality
Eltrombopag (Core Study) Avatrombopag (Core Study) Avatrombopag (Extension Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eltrombopag (Core Study) Avatrombopag (Core Study) Avatrombopag (Extension Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   2/12 (16.67%)   4/17 (23.53%) 
Blood and lymphatic system disorders       
Idiopathic thrombocytopenic purpura  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Hepatobiliary disorders       
Portal vein thrombosis  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Infections and infestations       
Bronchitis Moraxella  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Influenza  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Thrombophlebitis Septic  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Chronic lymphotic leukaemia  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Pneumothorax  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eltrombopag (Core Study) Avatrombopag (Core Study) Avatrombopag (Extension Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/11 (100.00%)   11/12 (91.67%)   16/17 (94.12%) 
Blood and lymphatic system disorders       
Idiopathic thrombocytopenic purpura  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Ear and labyrinth disorders       
Ear Pain  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Eye disorders       
Abnormal Sensation in Eye  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Eye disorder  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Eye irritation  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Eye pruritus  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Eye Swelling  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Gastrointestinal disorders       
Abdominal discomfort  1  1/11 (9.09%)  1/12 (8.33%)  3/17 (17.65%) 
Abdominal pain  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Abdominal pain upper  1  1/11 (9.09%)  1/12 (8.33%)  1/17 (5.88%) 
Constipation  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Diarrhoea  1  3/11 (27.27%)  2/12 (16.67%)  2/17 (11.76%) 
Gastrooesophageal reflux disease  1  1/11 (9.09%)  2/12 (16.67%)  2/17 (11.76%) 
Gastrointestinal haemorrhage  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Glossodynia  1  1/11 (9.09%)  1/12 (8.33%)  1/17 (5.88%) 
Haemorrhoids  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Nausea  1  2/11 (18.18%)  3/12 (25.00%)  3/17 (17.65%) 
Oral Mucosal blistering  1  1/11 (9.09%)  0/12 (0.00%)  1/17 (5.88%) 
Swollen tongue  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Vomiting  1  1/11 (9.09%)  1/12 (8.33%)  1/17 (5.88%) 
Dyspepsia  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Flatulence  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Mouth ulceration  2  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Rectal haemorrhage  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Stomatitis  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Toothache  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
General disorders       
Fatigue  1  5/11 (45.45%)  1/12 (8.33%)  5/17 (29.41%) 
Oedema peripheral  1  1/11 (9.09%)  0/12 (0.00%)  1/17 (5.88%) 
Asthenia  2  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Discomfort  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Pyrexia  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Hepatobiliary disorders       
Portal vein thrombosis  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Infections and infestations       
Bronchitis moraxella  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Cellulitis  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Gastroenteritis viral  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Influenza  1  1/11 (9.09%)  0/12 (0.00%)  1/17 (5.88%) 
Nasopharyngitis  1  3/11 (27.27%)  2/12 (16.67%)  4/17 (23.53%) 
Oral candidiasis  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Thrombophlebitis septic  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Upper respiratory tract infection  1  0/11 (0.00%)  1/12 (8.33%)  2/17 (11.76%) 
Gastroenteritis  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  1  2/11 (18.18%)  0/12 (0.00%)  1/17 (5.88%) 
Laceration  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Muscle strain  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Scratch  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Fall  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Cartilage injury  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Investigations       
Blood lactate dehydrogenase increased  1  0/11 (0.00%)  1/12 (8.33%)  2/17 (11.76%) 
Platelet count increased  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Weight increased  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Lymphocyte count increased  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Electrocardiogram abnormal  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Alanine aminotransferase increased  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Iron deficiency  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Vitamin D deficiency  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Hypophosphataemia  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/11 (18.18%)  1/12 (8.33%)  2/17 (11.76%) 
Limb discomfort  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Muscle spasms  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Musculoskeletal pain  1  0/11 (0.00%)  3/12 (25.00%)  3/17 (17.65%) 
Myalgia  1  0/11 (0.00%)  2/12 (16.67%)  3/17 (17.65%) 
Pain in extremity  1  0/11 (0.00%)  1/12 (8.33%)  3/17 (17.65%) 
Osteonecrosis  2  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Musculoskeletal chest pain  2  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Chronic lymphocytic leukaemia  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Nervous system disorders       
Dizziness  1  2/11 (18.18%)  3/12 (25.00%)  4/17 (23.53%) 
Dysgeusia  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Head discomfort  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Headache  1  3/11 (27.27%)  3/12 (25.00%)  5/17 (29.41%) 
Hypoaesthesia  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Paraesthesia  1  0/11 (0.00%)  2/12 (16.67%)  2/17 (11.76%) 
Sinus headache  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Psychiatric disorders       
Insomnia  1  1/11 (9.09%)  3/12 (25.00%)  4/17 (23.53%) 
Sleep disorder  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Menorrhagia  1  2/11 (18.18%)  1/12 (8.33%)  1/17 (5.88%) 
Nipple Pain  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Cough  1  2/11 (18.18%)  1/12 (8.33%)  1/17 (5.88%) 
Nasal congestion  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Oropharyngeal pain  1  1/11 (9.09%)  0/12 (0.00%)  1/17 (5.88%) 
Pneumothorax  1  0/11 (0.00%)  1/12 (8.33%)  1/17 (5.88%) 
Rhinorrhoea  1  1/11 (9.09%)  1/12 (8.33%)  1/17 (5.88%) 
Epistaxis  1  2/11 (18.18%)  0/12 (0.00%)  0/17 (0.00%) 
Haemoptysis  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Pleurisy  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Night Sweats  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Papule  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Pruritis  1  0/11 (0.00%)  1/12 (8.33%)  2/17 (11.76%) 
Rash pruritic  1  0/11 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Skin haemorrhage  2  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Blood blister  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Acne  1  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Vascular disorders       
Raynaud's phenomenon  2  1/11 (9.09%)  0/12 (0.00%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
2
Term from vocabulary, MedDRA VERSION 16.0
Study was terminated early (during the Extension Phase) due to significant enrollment changes.
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eisai Inc.
Organization: Eisai Call Center
Phone: 888-422-4743
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01433978     History of Changes
Other Study ID Numbers: E5501-G000-305
First Submitted: September 13, 2011
First Posted: September 14, 2011
Results First Submitted: December 5, 2017
Results First Posted: February 6, 2018
Last Update Posted: February 6, 2018