SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)

Purpura, Thrombocytopaenic, Idiopathic Clinical Trial

Official title:

See Detailed Description

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102739
• Other study ID #: TRA100773
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2005
• Last updated: April 11, 2013
• Start date: February 2005
• Est. completion date: January 2007

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose, study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of SB-497115-GR as a treatment for patients with ITP who have failed prior therapy. The study is designed to determine the proportion of patients with a platelet count =50,000/µL after 42 days. In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in a 2:1 ratio of active:placebo. During the 6 week study period, subjects will start on placebo or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count at day 22.

Description:

A double-blind, randomized, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of SB-497119-GR, a thrombopoietin receptor agonist, administered at 30, 50, and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenia purpura

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count.

• Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.

• Normal PT and PTT.

Exclusion criteria:

• History of clotting disorder.

• Females who are pregnant or are receiving hormone replacement therapy or systemic contraceptives.

• History of alcohol/drug abuse or dependence within 1 year.

• Use of aspirin, aspirin-containing compounds, salicylates, antacids, rosuvastatin, pravastatin, non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.

• History of HIV infection or active infection with Hepatitis B or C.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopaenic, Idiopathic
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• SB497115

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Bad Nauheim	Hessen
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Thessaloniki
Hong Kong	GSK Investigational Site	Pokfulam
Hong Kong	GSK Investigational Site	Shatin
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
New Zealand	GSK Investigational Site	Auckland
Pakistan	GSK Investigational Site	Lahore
Poland	GSK Investigational Site	Lodz
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Novosibirsk
Slovenia	GSK Investigational Site	Ljubljana
Slovenia	GSK Investigational Site	Maribor
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	ChiangMai
Thailand	GSK Investigational Site	Khon Kaen
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Reading	Berkshire
United Kingdom	GSK Investigational Site	Swansea
United Kingdom	GSK Investigational Site	Taunton	Somerset

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  Greece,  Hong Kong,  Korea, Republic of,  New Zealand,  Pakistan,  Poland,  Romania,  Russian Federation,  Slovenia,  Taiwan,  Thailand,  United Kingdom, 

References & Publications (2)

Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B, Kloczko J, Hassani H, Mayer B, Stone NL, Arning M, Provan D, Jenkins JM. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007 Nov 29;357(22):2237-47. — View Citation

Gibiansky E, Zhang J, Williams D, Wang Z, Ouellet D. Population pharmacokinetics of eltrombopag in healthy subjects and patients with chronic idiopathic thrombocytopenic purpura. J Clin Pharmacol. 2011 Jun;51(6):842-56. doi: 10.1177/0091270010375427. Epub 2010 Jul 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response, assessed by the proportion of patients with platelet counts of =50, 000/µL (compared with baseline count of <30, 000/µL) after 42 days of treatment.
Secondary	Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study.