MedTrace Logo

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

NCT03598725 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-07-26

No results posted yet for this study

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.

Conditions

  • Hemophilia A With Inhibitor

Interventions

DRUG

Coagulation Factor VIII

Domastic plasma derived factor FVIII (with intermidiate vWF) 50IU/kg every other day

DRUG

Prednisone

2mg/kg every day for 4 weeks then typering in 3 months

DRUG

Rituximab

375mg/Square meter for consecutive 4 months

Sponsors & Collaborators

  • Beijing Children's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2019-12-01
Completion
2020-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598725 on ClinicalTrials.gov