This is a first in human study, in patients with severe bleeding disorder (hemophilia A), who has developed inhibitory antibodies against coagulation factor VIII.The aim is to study the safety and efficacy of dendritic cells, originating from the patient itself. The dendritic cells has been loaded with coagulation factor VIII for an improved immunological tolerance. (TOLER8)
Phase 1
- Conditions
- Treatment of patients with Hemophilia A who have developed inhibitory antibodies to clotting Factor VIII and have failed Immune Tolerance InductionMedDRA version: 20.0Level: LLTClassification code: 10053751Term: Hemophilia A with anti factor VIII Class: 10010331Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]
- Registration Number
- CTIS2022-502030-12-01
- Lead Sponsor
- Idogen AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method