NCT01236014

Brief Summary

An indirect comparison to compare the efficacy of eltrombopag versus romiplostim

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

November 4, 2010

Last Update Submit

June 6, 2017

Conditions

Thrombocytopaenia

Outcome Measures

Primary Outcomes (2)

  • Durable response: platelet count of >=50 and <400 Gi/L

    6 months

  • Overall response: either a durable response or a transient platelet response

    6 months

Study Arms (3)

Eltrombopag & standard of care

Drug: Eltrombopag

Romiplostim & standard of care

Drug: Romiplostim

Standard of care

Drug: Placebo

Interventions

EltrombopagDRUG

Eltrombopag \& standard of care

Eltrombopag & standard of care
RomiplostimDRUG

Romiplostim \& standard of care

Romiplostim & standard of care
PlaceboDRUG

Placebo \& standard of care

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Identified through a systematic review: TRA102537, Kuter 2008

You may qualify if:

  • Adults with ITP
  • Pre-specified treatment
  • Prospective clinical studies with at least 10 patients

You may not qualify if:

  • Adults with ITP for other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thrombocytopenia

Interventions

eltrombopagromiplostim

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 8, 2010

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

June 7, 2017

Record last verified: 2017-06