Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids.
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
Summary
Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national
diagnostic criteria. Patients who meet all inclusion criteria and conflict the exclusion
criteria will receive NPB-01(intravenous immunoglobulin) 400mg/kg/day for five consecutive
days or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for therapy of
bullous pemphigoid will evaluate using pemphigoid activity score involving skin lesion area
and Number of new blisters.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse
events by 57 days after the start of the study treatment.