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

NCT ID: NCT00828750

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-02-28

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).

Conditions

Idiopathic Thrombocytopenic Purpura; Purpura, Thrombocytopenic, Idiopathic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Eltrombopag oral tablets once daily

Group Type: EXPERIMENTAL

Eltrombopag oral tablets

Intervention Type: DRUG

Eltrombopag oral tablets once daily

Interventions

Eltrombopag oral tablets

Eltrombopag oral tablets once daily

Intervention Type: DRUG

Other Intervention Names

SB-497115-GR oral tablets

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).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Gifu, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 23896965 (View on PubMed)

Other Identifiers

111433

Identifier Type: -

Identifier Source: org_study_id