NCT01013181

Brief Summary

The purpose of this study is to review the charts of the first 100 patients included in the french compassionate program including patients with Immune Thrombopenia receiving romiplostim.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
Last Updated

November 17, 2009

Status Verified

November 1, 2009

Enrollment Period

6 months

First QC Date

November 12, 2009

Last Update Submit

November 16, 2009

Conditions

Thrombopenia

Keywords

Immune ThrombopeniaThrombocytopeniaromiplostimcompassionate program

Outcome Measures

Primary Outcomes (1)

  • Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP)

Eligibility Criteria

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

Patients with primary Immune Thrombopenia receiving romiplostim in a compasionnate program

You may qualify if:

  • Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).
  • Subject is equal to or greater than 18 years of age.
  • Before any study-specific procedure, the appropriate written informed consent must be obtained.

You may not qualify if:

  • Secondary ITP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Khellaf M, Michel M, Quittet P, Viallard JF, Alexis M, Roudot-Thoraval F, Cheze S, Durand JM, Lefrere F, Galicier L, Lambotte O, Panelatti G, Slama B, Damaj G, Sebahoun G, Gyan E, Delbrel X, Dhedin N, Royer B, Schleinitz N, Rossi JF, Mahevas M, Languille L, Bierling P, Godeau B. Romiplostim safety and efficacy for immune thrombocytopenia in clinical practice: 2-year results of 72 adults in a romiplostim compassionate-use program. Blood. 2011 Oct 20;118(16):4338-45. doi: 10.1182/blood-2011-03-340166. Epub 2011 Aug 10.

    PMID: 21832276DERIVED

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 13, 2009

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

August 1, 2009

Last Updated

November 17, 2009

Record last verified: 2009-11