Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00828750
First received: January 22, 2009
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

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).


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Purpura, Thrombocytopenic, Idiopathic
Drug: Eltrombopag oral tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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>

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category [ Time Frame: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    Platelet counts were measured by blood draw.

  • Median Platelet Counts [ 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) ] [ Designated as safety issue: No ]
    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.) [ Time Frame: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) ] [ Designated as safety issue: No ]
    Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.


Enrollment: 19
Study Start Date: May 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Eltrombopag oral tablets once daily
Drug: Eltrombopag oral tablets
Eltrombopag oral tablets once daily
Other Name: SB-497115-GR oral tablets

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828750

Locations
Japan
GSK Investigational Site
Gifu, Japan, 503-8502
GSK Investigational Site
Hiroshima, Japan, 734-8551
GSK Investigational Site
Ibaraki, Japan, 305-8576
GSK Investigational Site
Osaka, Japan, 565-0871
GSK Investigational Site
Osaka, Japan, 596-8501
GSK Investigational Site
Tokyo, Japan, 160-8582
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00828750     History of Changes
Other Study ID Numbers: 111433
Study First Received: January 22, 2009
Results First Received: September 15, 2011
Last Updated: October 31, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
eltrombopag
thrombopoietin receptor agonist
ITP
blood platelet

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on September 22, 2014