A Phase 2 interventional study of NPB-01 and Placebo in Bullous Pemphigoid, sponsored by Nihon Pharmaceutical Co., Ltd. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2010-10-25.
Sponsored by Nihon Pharmaceutical Co., Ltd · Phase 2, Interventional, and Treatment
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.
73 studies on the registry are indexed under Pemphigoid, Bullous; 11 are open to participants now.
This study's planned enrollment of 20 is below the median of 29 across 43 interventional studies indexed under Pemphigoid, Bullous.
Browse Pemphigoid, Bullous studies →Nihon Pharmaceutical Co., Ltd is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous immunoglobulin
Drug: NPB-01
Physiological saline
Drug: Placebo
Intravenous immunoglobulin
Physiological saline
Skin lesion area (%), Number of new blisters/day, Pemphigoid Activity Score, Pemphigus Disease Area Index(PDAI), anti-BP180 and -BP230 antibody titers, Steroid dose, Time to escape from the protocol and its ratio
Time frame: 57 days
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Nihon Pharmaceutical Co., Ltd