Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP): Efficacy and Safety.

NCT01618734 | Completed

• 2 other identifiers: TPO-r switchTPO-r Switch in ITP
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP) who received alternatively romiplostim and eltrombopag.

Conditions

Immune Thrombocytopenia; Thrombopoietin Receptor Agonist

Keywords

Immune Thrombocytopenia; Thrombopoietin receptor agonist

Outcome Measures

Primary Outcomes (1)

• Rate of efficacy after switching from one TPO mimetics to a second one.

  The primary outcome of this study is to know if switching from one TPO mimetics to a second one in ITP patients lead to a better efficacy in a significative proportion of patients.

  2 months minimun

Secondary Outcomes (1)

• Rate of patients with an adverse events who have a benefit after switching.

  6 months

Study Arms (1)

Romiplostim and eltrombopag in ITP

ITP patients who received alternatively romiplostim or eltrombopag with at least two months of follow-up for each period.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary Immune Thrombopenia receiving romiplostim and eltrombopag alternatively.

You may qualify if:

• Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (Rodeghiero et al, 2009).
• 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 and eltrombopag alternatively
• Available follow-up of 2 months at least for each period

You may not qualify if:

• \- Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia

Sponsors & Collaborators

• Henri Mondor University Hospital: lead
• Paris 12 Val de Marne University: collaborator

Related Publications (1)

• Khellaf M, Viallard JF, Hamidou M, Cheze S, Roudot-Thoraval F, Lefrere F, Fain O, Audia S, Abgrall JF, Michot JM, Dauriac C, Lefort S, Gyan E, Niault M, Durand JM, Languille L, Boutboul D, Bierling P, Michel M, Godeau B. A retrospective pilot evaluation of switching thrombopoietic receptor-agonists in immune thrombocytopenia. Haematologica. 2013 Jun;98(6):881-7. doi: 10.3324/haematol.2012.074633. Epub 2013 Feb 26.

  PMID: 23445876 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 13, 2012

Record last verified: 2012-06