Meta-analysis - Eltrombopag

Thrombocytopaenia Clinical Trial

Official title:

Systematic Review of the Clinical and Cost Effectiveness of Treatments for Idiopathic (Immune) Thrombocytopenic Purpura (ITP): Direct Meta Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235988
• Other study ID #: 114013
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: June 6, 2017
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo (standard of care)

Description:

Meta-analysis of three studies: Bussell 2007 & Bussell 2009 & RAISE (TRA102537).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with ITP

• Received a pre-specified treatment

• Prospective clinical studies with at least 10 patients

Exclusion Criteria:

• Subjects with ITP due to other causes

Related Conditions & MeSH terms

• Thrombocytopaenia
• Thrombocytopenia

Intervention

Drug:
• Eltrombopag
Eltrombopag 50mg & standard of care
• Placebo
Placebo + standard of care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	>=50 Gi/L platelet count to <400 Gi/L		43 days