Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Nec… (NCT01696500) | Clinical Trial Compass
CompletedPhase 3
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Japan10 participantsStarted 2012-10
Plain-language summary
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be evaluated the disease evaluation score et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 20 days after the start of the study treatment.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Patients who the disease evaluation score is more than 14 at study medication received.
✓. Patients with corticosteroids over 20mg/day(Prednisolone) at study medication received and continued this treatment more than 2 days.
✓. Patients with treatment effect is insufficiency before study medication received and need additional treatment.
✓. Patients aged more than twenty years old at informed consent.
Exclusion criteria
✕. Patients who the SCORTEN score is more than 4 at study medication received.
✕. Patients with multiple organ failure at study medication received.
✕. Patients with severe respiratory disorder at study medication received.
✕. Patients with Drug-induced hypersensitivity syndrome (DIHS) at informed consent.
✕. Patients with malignancy during treatment at informed consent.