Evaluation of perioperative eltrombopag in patients with inherited thrombocytopenia

Phase 1

• Conditions: Inherited thrombocytopenias; MedDRA version: 20.0Level: HLTClassification code 10043555Term: ThrombocytopeniasSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-004489-88-FR
• Lead Sponsor: CHU Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-11
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Related to patients: Symptomatic inherited thrombocytopenia (IT) with family history and/or molecular identification with an average platelet count in the previous year below the safety level required for the procedure. Written informed consent of the patient or relatives.
Related to the procedure: scheduled (=4 weeks) invasive procedure with anticipated risk and limited possibility of mechanical control of bleeding, which would have systematically required prophylactic and therapeutic PC transfusions, according to current international recommendations (standard care).

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•age <6 and >75 yrs
•personal history of arterial or venous thromboembolic events
•association with another acquired or constitutional hemorrhagic diathesis
•chronic hepatitis, cirrhosis, with moderate to severe liver failure (Child-Pugh score =5)
•previous or concurrent myeloid malignancy, including myelodysplastic syndrome
•alanine aminotransferase (ALT) or bilirubin levels 2 times the upper limit of normal
•severe altered renal function (creatinin clearance <30 ml/min)
•pregnancy (negative test required before inclusion in fertile women) or lactating women
•refusal of safe contraception
•ocular lenses opacity
•hypersensitivity to eltrombopag or one of excipients
•previous participation to the present study
•current treatment with antiplatelet drugs, anticoagulants or direct acting antiviral agents approved for treatment of chronic hepatitis C infection
•psychiatric, social or behavioral condition judged to be non-compatible with the respect of the protocol, including good observance of treatment and compliance to follow-up.
•adult protected by the law.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified