Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia

Status Recruiting

Clinical Trial Summary

To evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons.

Clinical Trial Description

Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. ITP is a kind of disease with increased platelet destruction and impaired platelet production caused by autoimmunity. Conventional treatment of adult ITP includes first-line glucocorticoid and immunoglobulin therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.). Eltrombopag is currently the only TPO receptor agonist with indications for pediatric immune thrombocytopenia. However, at present, the treatment response of pediatric ITP is not good, and a considerable number of patients need to switched to other TPO receptor agonist, such as avatrombopag, because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons. Therefore, the investigators designed this clinical trial to evaluate the efficacy and safety of avatrombopag in the treatment of pediatric immune thrombocytopenia in patients who who have been treated with eltrombopag before and switched to avatrobopag because of different reasons. ;

Study Design

Related Conditions & MeSH terms

Immune Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Thrombocytopenia
Treatment

Clinical Trial Details

NCT number	NCT06281327
Study type	Interventional
Source	Institute of Hematology & Blood Diseases Hospital, China
Contact	Lei Zhang, MD
Phone	+86 13502118379
Email	zhanglei1@ihcams.ac.cn
Status	Recruiting
Phase	Phase 2
Start date	March 2024
Completion date	December 2025

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	`NCT02556814` - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP	Phase 4
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	`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	`NCT05494307` - The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia	Phase 2
Not yet recruiting	`NCT05468866` - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia	N/A
Recruiting	`NCT04993885` - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies	Phase 2
Recruiting	`NCT05281068` - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia	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
Withdrawn	`NCT01976195` - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP	Phase 2
Completed	`NCT01933035` - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.	N/A
Recruiting	`NCT02821572` - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)