Back to resultsClinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Primary Purpose
Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Eltrombopag oral tablets
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura focused on measuring eltrombopag, thrombopoietin receptor agonist, ITP, blood platelet
Eligibility Criteria
Inclusion Criteria:
- Subject has signed and dated written informed consent.
- Subject (>=20 years) diagnosed with ITP.
- Subject previously enrolled in TRA108109 (NCT00540423) must have completed the treatment and follow-up periods as defined in that protocol.
- Subject has no intercurrent medical event at risk of thrombosis such as thrombophilia.
- Prolongation of prothrombin time and activated partial thromboplastin time (aPTT) must be within 1.2 times the upper limit of the normal range with no history of hypercoagulable state.
- A complete blood count (CBC), within the reference range, with the following exceptions:
- Hemoglobin: patients with haemoglobin level < the lower limit of normal are eligible for inclusion if hemorrhage is present.
- Neutrophil count >= 1,500/L (1.5x10E9/L) is required for inclusion.
- The following clinical chemistries MUST NOT exceed 1.2 times the upper limit of the normal reference range: creatinine, total bilirubin and alkaline phosphatase.
- The following clinical chemistries MUST NOT exceed 2 times the upper limit of the normal reference range: ALT and AST.
- Albumin must be not less than 80% of the lower limit of normal.
- Female subjects must either be:
- of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or
- of childbearing potential and have a negative pregnancy test and agree to use contraceptive methods specified in the GSK List of Highly Effective Methods for Avoidance of Pregnancy from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:
- Reticulocyte count within the reference range or elevated in case of bleeding.
Exclusion Criteria:
- Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic ITP. (Note: "Severe" is defined as >= Grade 3 as a rule according to the "Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80, dated 29 June 1992)
- History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial infarction, deep vein thrombosis) within the last 1 year.
- History of drug/alcohol abuse or dependence within the last 1 year.
- Suspected blood disorder other than ITP.
- Suspected platelet aggregation abnormality.
- Suspected cyclic thrombocytopenia.
- Suspected Evans Syndrome.
- Subjects who met the GSK Liver Stopping Criteria in the previous eltrombopag study TRA108109 (NCT00540423).
- Current or history of HIV infection or hepatitis B virus or hepatitis C virus infections.
- Current malignancy or history of malignancy that was treated with chemotherapy or radiotherapy.
- Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- Subjects who are deemed unsuitable for the study by the investigator (or subinvestigator).
- Treatment with an investigational drug within 30 days preceding the first dose of study medication.
- Pre-existing cardiovascular disease, or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Eltrombopag oral tablets once daily
Outcomes
Primary Outcome Measures
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.
Secondary Outcome Measures
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Platelet counts were measured by blood draw.
Median Platelet Counts
Platelet counts were measured by blood draw.
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).
Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication
Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.
Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy
Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00828750
Brief Title
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Official Title
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)-<Phase III Study>
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic
Keywords
eltrombopag, thrombopoietin receptor agonist, ITP, blood platelet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Eltrombopag oral tablets once daily
Intervention Type
Drug
Intervention Name(s)
Eltrombopag oral tablets
Other Intervention Name(s)
SB-497115-GR oral tablets
Intervention Description
Eltrombopag oral tablets once daily
Primary Outcome Measure Information:
Title
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.
Time Frame
From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Description
Platelet counts were measured by blood draw.
Time Frame
Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)
Title
Median Platelet Counts
Description
Platelet counts were measured by blood draw.
Time Frame
Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)
Title
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Description
Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
Time Frame
From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
Title
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
Description
Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
Time Frame
3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)
Title
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Description
Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).
Time Frame
Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)
Title
Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication
Description
Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.
Time Frame
From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
Title
Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy
Description
Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.
Time Frame
From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has signed and dated written informed consent.
Subject (>=20 years) diagnosed with ITP.
Subject previously enrolled in TRA108109 (NCT00540423) must have completed the treatment and follow-up periods as defined in that protocol.
Subject has no intercurrent medical event at risk of thrombosis such as thrombophilia.
Prolongation of prothrombin time and activated partial thromboplastin time (aPTT) must be within 1.2 times the upper limit of the normal range with no history of hypercoagulable state.
A complete blood count (CBC), within the reference range, with the following exceptions:
Hemoglobin: patients with haemoglobin level < the lower limit of normal are eligible for inclusion if hemorrhage is present.
Neutrophil count >= 1,500/L (1.5x10E9/L) is required for inclusion.
The following clinical chemistries MUST NOT exceed 1.2 times the upper limit of the normal reference range: creatinine, total bilirubin and alkaline phosphatase.
The following clinical chemistries MUST NOT exceed 2 times the upper limit of the normal reference range: ALT and AST.
Albumin must be not less than 80% of the lower limit of normal.
Female subjects must either be:
of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or
of childbearing potential and have a negative pregnancy test and agree to use contraceptive methods specified in the GSK List of Highly Effective Methods for Avoidance of Pregnancy from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:
Reticulocyte count within the reference range or elevated in case of bleeding.
Exclusion Criteria:
Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic ITP. (Note: "Severe" is defined as >= Grade 3 as a rule according to the "Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80, dated 29 June 1992)
History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial infarction, deep vein thrombosis) within the last 1 year.
History of drug/alcohol abuse or dependence within the last 1 year.
Suspected blood disorder other than ITP.
Suspected platelet aggregation abnormality.
Suspected cyclic thrombocytopenia.
Suspected Evans Syndrome.
Subjects who met the GSK Liver Stopping Criteria in the previous eltrombopag study TRA108109 (NCT00540423).
Current or history of HIV infection or hepatitis B virus or hepatitis C virus infections.
Current malignancy or history of malignancy that was treated with chemotherapy or radiotherapy.
Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
Subjects who are deemed unsuitable for the study by the investigator (or subinvestigator).
Treatment with an investigational drug within 30 days preceding the first dose of study medication.
Pre-existing cardiovascular disease, or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
596-8501
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23896965
Citation
Katsutani S, Tomiyama Y, Kimura A, Miyakawa Y, Okamoto S, Okoshi Y, Ninomiya H, Kosugi H, Ishii K, Ikeda Y, Hattori T, Katsura K, Kanakura Y. Oral eltrombopag for up to three years is safe and well-tolerated in Japanese patients with previously treated chronic immune thrombocytopenia: an open-label, extension study. Int J Hematol. 2013 Sep;98(3):323-30. doi: 10.1007/s12185-013-1401-1. Epub 2013 Jul 30.
Results Reference
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Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
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