Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP)

Status Not yet recruiting

Clinical Trial Summary

This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy

Clinical Trial Description

This is an open-label, single-arm study of lusutrombopag initiated at a dose of 3mg daily titrated to a maximum dose of 6mg daily in the treatment of Chinese adults with persistent or chronic Immune thrombocytopenia (ITP) with or without prior splenectomy after failing first line therapy such corticosteroids and IV immunoglobulin. The study consists of three phases: Screening, Core Study（participants are treated with lusutrombopag 3mg daily for 4 weeks), and Titration study (participants are treated with lusutrombopag titrated to a maximum dose of 6mg daily according to their platelet counts ;

Study Design

Related Conditions & MeSH terms

Idiopathic Thrombocytopenic Purpura
Immune Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Thrombocytopenia

Clinical Trial Details

NCT number	NCT06287567
Study type	Interventional
Source	Institute of Hematology & Blood Diseases Hospital, China
Contact	Liu Xiaofan
Phone	+8602223909240
Email	liuxiaofan@ihcams.ac.cn
Status	Not yet recruiting
Phase	Phase 4
Start date	March 20, 2024
Completion date	November 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02287649` - Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP)	N/A
Completed	`NCT02868099` - Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)	Phase 3
Terminated	`NCT02401061` - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP	Phase 1/Phase 2
Completed	`NCT02556814` - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP	Phase 4
Completed	`NCT02351622` - Caffeic Acid Tablets as a Second-line Therapy for ITP	Phase 3
Active, not recruiting	`NCT04741139` - Post IVIG Medication in Children With Immune Thrombocytopenia	Phase 1
Not yet recruiting	`NCT05468866` - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia	N/A
Not yet recruiting	`NCT05494307` - The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia	Phase 2
Recruiting	`NCT05281068` - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia	Phase 2
Recruiting	`NCT04993885` - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies	Phase 2
Not yet recruiting	`NCT05020288` - A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP	Phase 2
Withdrawn	`NCT03965624` - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia	Phase 2
Not yet recruiting	`NCT03252457` - Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP	Phase 3
Recruiting	`NCT05937828` - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Completed	`NCT03156452` - Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate	Phase 3
Completed	`NCT03164915` - A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)	Phase 3
Recruiting	`NCT02270801` - Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy	Phase 3
Completed	`NCT01933035` - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.	N/A
Withdrawn	`NCT01976195` - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP	Phase 2
Recruiting	`NCT02821572` - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)