INdividualized ITI Based on Fviii(ATE) Protection by VWF
Stopped early · Phase 4
Conditions studied: Hemophilia A With Inhibitor, Hemophilia A
In brief
The primary goal of the INITIATE trial is to compare the clinical outcome of individualized lot selection to random lot selection utilizing one plasma-derived von Willebrand factor (VWF)/coagulation factor (FVIII) complex concentrate for immune tolerance induction (ITI) in subjects with congenital Hemophilia A, FVIII activity ≤2%, and a historical high-titer inhibitor \[≥5 Bethesda Unit (BU)\].
Key facts
- Study ID
- NCT03204539
- Run by
- University of California, Davis
- People needed
- 1
- Starts
- 2017-06-01
- Expected to finish
- 2019-07-19
- Last updated by the study team
- 2020-05-29
Who can join
Age: any. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of congenital Hemophilia A and baseline FVIII ≤2%.
- Weight ≥ 5 kg
- History of FVIII inhibitor titer ≥5 BU
- Current FVIII inhibitor titer ≥5 BU or ≥0.6 BU and failed ITI defined by FVIII recovery <66% normal and half-life <6 hours
- Adequate venous access for daily concentrate infusions
- For participants <18 years, a parent or guardian willing and able to provide informed consent with verbal or written assent from the child if require by the local institution. For participants ≥18 years, a willingness and ability to provide informed consent from the subject.
- Ability to comply with study related treatments, evaluations, and follow-up.
You may not qualify if…
- Acquired hemophilia
- Congenital or acquired bleeding disorder in addition to Hemophilia A
- ITI factor replacement regimen within the past one month unless there is clear evidence of ITI failure with no reduction in inhibitor titer over the past two months
- HIV positive with viral load ≥200 particles/μL or ≥400,000 copies/mL
- Rituximab within the past 3 months
- IVIG within the past 1 month
- Treatment with other immunosuppressive drugs within the past 1 month (excluding intermittent steroid use for asthma)
- Concomitant experimental treatment
- History of hypersensitivity to plasma-derived VWF- or FVIII-containing concentrates
- Elective surgery planned in the next 6 months (excluding vascular access procedure)
- Any condition or chronic illness, which in the opinion of the investigator makes participation ill-advised
- Inability or unwillingness to complete required screening, follow-up, and exit studies
Where it is running
- University of California, Davis — Sacramento, California, United States
- Rady Children's Hospital San Diego — San Diego, California, United States
- Tulane University — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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