Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) in the " Real-life " : Result of the French Experience in 72 Adults
NCT ID: NCT01013181
Last Updated: 2009-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
100 participants
OBSERVATIONAL
2008-01-31
2009-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP
NCT02338414
Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP): Efficacy and Safety.
NCT01618734
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)
NCT02279173
Immunomodulation With Romiplostim in Young Adults With ITP
NCT02760251
Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia
NCT07206823
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
* Subject receiving romiplostim in the compassionate program
* Available follow-up of one-year
Exclusion Criteria:
•Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia...
The goal of this study is to review retrospectively the charts of the 100 first patients including in this program in France during the period of January 2008 and July 2008.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject is equal to or greater than 18 years of age.
* Before any study-specific procedure, the appropriate written informed consent must be obtained.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Paris 12 Val de Marne University
OTHER
Henri Mondor University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amgen Laboratory
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ATU Romiplostim registry
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.