Clinical Trials Logo
  1. Home
  2. Hemophilia A With Inhibitor
  3. NCT03598725

Low-dose ITI Strategy for Children in Hemophilia A With High-titer Inhibitor and Poor ITI Risk in China — HA-LD-ITI  

Hemophilia A With Inhibitor Clinical Trial

Official title:
Beijing Children's Hospital, Capital Medical University

Clinical Trial Summary

The study start on January 18, 2017. The Severe(FⅧ<1%) and moderate hemophilia A (FⅧ1%～5%)children with high titer inhibitor(historical peak inhibitor titer≥5BU ) combining with poor ITI risk(s) were enrolled. The low-dose ITI was alone or combined with immunosuppression.

Clinical Trial Description

Poor risk(s) includes:①peak historical inhibitor titer≥200BU ②inhibitor titer≥10BU before ITI initiation ③peak inhibitor titer during ITI≥200BU ④time to titer decline to<10BU before ITI≥24 months ⑤age≥8 years at start of ITI ⑥ITI initiated ≥5 years after inhibitor diagnosis ⑦interruptions in ITI≥2 weeks in duration. The low-dose ITI strategy consist of FⅧ（25-50IU/kg）alone or combining with immunosuppression: prednisone and Rituximab when the inhibitor titer ≥40BU ml/ml before or during ITI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03598725
Study type Interventional
Source Beijing Children's Hospital
Contact Xin Ni, master
Phone 010-59616643
Email nixin@bch.com.cn
Status Recruiting
Phase Phase 4
Start date January 1, 2016
Completion date December 1, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06320626 - Pharmacokinetic-guided Dosing of Emicizumab Phase 4
Completed NCT04072237 - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia Phase 1
Not yet recruiting NCT02554526 - Basic Study of Combination Therapy Based on APCC-induced FVllI Activation in Hemophilia A Patients With Inhibitors N/A
Completed NCT03818529 - ATHN 8: Previously Untreated Patients (PUPs) Matter Study
Active, not recruiting NCT03619863 - ATHN 7: Hemophilia Natural History Study
Recruiting NCT06010953 - SS109 and NovoSeven ® PK / PD Profile, and Preliminary Efficacy and Safety of SS109 on Demand Treatment Phase 1/Phase 2
Completed NCT03951103 - rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
Recruiting NCT05888870 - ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor Phase 4
Terminated NCT04303572 - The Hemophilia Inhibitor Eradication Trial Phase 3
Terminated NCT04489537 - Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B Phase 3
Terminated NCT04548791 - Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders Phase 1/Phase 2
Completed NCT06357572 - Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem
Recruiting NCT04647227 - SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors Phase 4
Completed NCT03372993 - Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven
Terminated NCT03204539 - INdividualized ITI Based on Fviii(ATE) Protection by VWF Phase 4
Active, not recruiting NCT04205175 - A Study to Evaluate the Safest Dose Range for FEIBA in Hemophilia A Patients With Inhibitors on Emicizumab Phase 4
Recruiting NCT06312475 - Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors Phase 3
Completed NCT04723693 - An Exploration of the Impact of Emicizumab on the Lives of People With Haemophilia and Inhibitors and Their Families
Completed NCT04789954 - Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors Early Phase 1
Recruiting NCT04592692 - A Pharmacokinetic and Clotting Activity Study of FVIII-PEGLip Phase 2