TPO-RAs Combining Anti-CD 20 Monoclonal Antibody Versus TPO-RAs in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)

PHASE4RecruitingINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

February 23, 2023

Primary Completion Date

May 14, 2025

Study Completion Date

November 14, 2025

Conditions
Primary Immune Thrombocytopenia (ITP)
Interventions
DRUG

TPO-RAs

After enrollment, all subjects receive TPO-RAs treatment. The initial dose of eltrombopag, hetrombopag and avatrombopag administration were the same as described in arm description. Complete blood count including platelet count was done once a week. The dose of TPO-RAs was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the TPO-RAs will stop until the platelet count \<100×10\^9/L.

DRUG

TPO-RAs combining anti-CD 20 monoclonal antibody

"After enrollment, all subjects receive TPO-RAs treatment. The initial dose of eltrombopag, hetrombopag and avatrombopag administration were the same as described in arm description.The dose of TPO-RAs was adjusted according to the subject platelet count during the period from week 1 to week 24.~Subjects in TPO-RAs combining anti-CD 20 monoclonal antibody treatment group received single dose infusion of Rituximab 375 mg/m2 within 14 days after enrollment. Subjects weighing less than 30kg will be given Rituximab 100 mg once a week for four times. Ortuzumab at 1000mg/ dose is also recommended for subjects weighing 45kg or greater.~Ps.Participants in the TPO-RAs monotherapy group who have platelet count \< 20×10\^9/L or significant skin and mucosal bleeding at the end of 12 weeks of treatment will be given a single dose of Rituximab 375mg/m2 or Ortuzumab at 1000mg/ dose if weighing 45kg or greater."

Trial Locations (1)

Unknown

RECRUITING

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin

All Listed Sponsors
collaborator

Beijing Children's Hospital

OTHER

collaborator

Tianjin People's Hospital

OTHER

collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

collaborator

Henan Cancer Hospital

OTHER_GOV

collaborator

Tianjin Medical University Second Hospital

OTHER

collaborator

The First Affiliated Hospital of Xiamen University

OTHER

lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER