Low-dose ITI Strategy for Children in Hemophilia A With High-titer Inhibitor and Poor ITI Risk in China
HA-LD-ITI
Beijing Children's Hospital, Capital Medical University
1 other identifier
interventional
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 23, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 26, 2018
July 1, 2018
3.9 years
January 23, 2018
July 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Success rate
Success rate
2 years
Secondary Outcomes (3)
Annualized Bleeding Rate
2 year
Annualized Joint Bleeding Rate
2 year
Success time
2 years
Study Arms (1)
ITI strategy
EXPERIMENTALThe low-dose ITI was Coagulation Factor VIII (50IU/kg, every other day) alone or combined with prednisone (2mg Kg-1/day, one month, then taper in three months) depending on the tendency of inhibitor, and Rituximab (375mg/square meter every week for 4 weeks) when the inhibitor titer ≥40BU/ml before or during ITI.Inhibitor and hemorrhage should be retested and recorded periodically.
Interventions
Domastic plasma derived factor FVIII (with intermidiate vWF) 50IU/kg every other day
Eligibility Criteria
You may qualify if:
- Males
- from 1 to 14 years old
- severe or moderate hemophilia A;
- inhibitors positive before ITI started.
You may not qualify if:
- Females
- \<1 or \>14 years old
- hemophilia B or mild haemophilia A;
- inhibitor negative before ITI started.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Children's Hospital
Beijing, Beijing Municipality, 100045, China
Related Publications (1)
Li Z, Tang Y, Chen Z, Liu G, Yao W, Li G, Cheng X, Peng Y, Cai S, Cui C, Ai D, Zhang J, Poon MC, Zhang W, Wu R. Outcomes of immune tolerance induction with rituximab to eradicate high-titer inhibitor of hemophilia A: depicted by exponential decay model and the gene expression profile of different outcomes by RNA-sequencing. J Thromb Haemost. 2025 Aug;23(8):2436-2448. doi: 10.1016/j.jtha.2025.04.015. Epub 2025 Apr 24.
PMID: 40286913DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Capital Medical Univercity
Study Record Dates
First Submitted
January 23, 2018
First Posted
July 26, 2018
Study Start
January 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2020
Last Updated
July 26, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share