Indirect Comparison Between Eltrombopag & Romiplostim

Thrombocytopaenia Clinical Trial

Official title:

Indirect Comparison of Efficacy of Treatments for Idiopathic Immune Thrombocytopenic Purpura - Review of Platelet Responses and Bleeding Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236014
• Other study ID #: 114014
• 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

An indirect comparison to compare the efficacy of eltrombopag versus romiplostim

Description:

An indirect analysis was conducted to evaluate the relative efficacy of eltrombopag and romiplostim using placebo as a common comparator

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

• Pre-specified treatment

• Prospective clinical studies with at least 10 patients

Exclusion Criteria:

• Adults with ITP for other reasons

Related Conditions & MeSH terms

• Thrombocytopaenia
• Thrombocytopenia

Intervention

Drug:
• Eltrombopag
Eltrombopag & standard of care
• Romiplostim
Romiplostim & 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	Durable response: platelet count of >=50 and <400 Gi/L		6 months
Primary	Overall response: either a durable response or a transient platelet response		6 months