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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00908037 |
Purpose
Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized, placebo controlled study involving 3 age-determined cohorts (Cohort 1: between 12 and 17 years old; Cohort 2: between 6 and 11 years old; Cohort 3: between 1 and 5 years old). Daily dosing with eltrombopag will begin with 5 patients in the oldest age cohort in an open label fashion, and a review of safety, pharmacokinetic and platelet count data will be performed regularly. If no safety concerns are identified after 12 weeks, 18 additional patients will be randomised to placebo or eltrombopag (2:1 randomisation). After 7 weeks of randomized treatment, all patients will receive eltrombopag in an open label fashion. The total duration of treatment with eltrombopag will be 24 weeks. If at the time of the aforementioned 12 week review of the first 5 patients no safety issues are identified, dosing will begin in the next lower age cohort with an initial group of 5 patients. The same procedure will be followed in terms of safety review and subsequent enrolment and randomisation of the additional patients. Initiation of the younger age cohort will take place once data from the previous has been evaluated. Doses will be adjusted according to platelet counts and tolerability. The study will include a review of the safety data by a Data Safety Monitoring Board.
| Condition | Intervention | Phase |
|---|---|---|
|
Purpura, Thrombocytopenic, Idiopathic Immune Thrombocytopenic Purpura |
Drug: eltrombopag Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Three Part, Staggered Cohort, Open-label and Double Blind, Randomized, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of Eltrombopag, a Thrombopoietin Receptor Agonist, in Previously Treated Pediatric Patients With Chronic ITP. |
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: eltrombopag plus standard of care
eltrombopag
|
Drug: eltrombopag
thrombopoietin receptor agonist
|
| Placebo Comparator: placebo plus standard of care |
Drug: Placebo
placebo for comparison
|
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Show 31 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00908037 History of Changes |
| Other Study ID Numbers: | 108062 |
| Study First Received: | May 21, 2009 |
| Last Updated: | August 25, 2011 |
| Health Authority: | Spain: Agencia Española del Medicamento y Productos Sanitarios; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada; France: Agence Française de Sécurité Sanitaire des Produits de Santé; United States: Food and Drug Administration |
|
idiopathic thrombocytopenic purpura thrombocytopenia pharmacodynamics ITP |
eltrombopag pharmacokinetics chronic ITP pediatrics |
|
Purpura Purpura, Thrombocytopenic Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes |
Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases |