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

January 22, 2009
October 31, 2011
May 2008
February 2011   (final data collection date for primary outcome measure)
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.
To evaluate the long-term safety of Eltrombopag of subjects with ITP [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00828750 on ClinicalTrials.gov Archive Site
  • 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.
To evaluate the efficacy of oral eltrombopag, when administered once daily, to subjects with ITP [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
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>

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).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Idiopathic Thrombocytopenic Purpura
  • Purpura, Thrombocytopenic, Idiopathic
Drug: Eltrombopag oral tablets
Eltrombopag oral tablets once daily
Other Name: SB-497115-GR oral tablets
Experimental: Treatment
Eltrombopag oral tablets once daily
Intervention: Drug: Eltrombopag oral tablets
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
February 2011
February 2011   (final data collection date for primary outcome measure)

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).
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00828750
111433
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP