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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00828750
• Date of registration: 22/01/2009
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
• Scientific 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)-
• Date of first enrolment: May 2008
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00828750
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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).



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura

Purpura, Thrombocytopenic, Idiopathic

Intervention(s)

Drug: Eltrombopag oral tablets

Primary Outcome(s)

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)]

Secondary Outcome(s)

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)]

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)]

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)]

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)]

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)]

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)]

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)]

Secondary ID(s)

111433

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/12/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00828750