Clinical Trial: Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignm
Brief Summary:
Patients diagnosed with bullous pemphigoid 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 or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for therapy of bullous pemphigoid will be evaluated the score using pemphigus disease area index (PDAI) and 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.
Detailed Summary:
Sponsor: Nihon Pharmaceutical Co., Ltd
Current Primary Outcome: The score using Pemphigus Disease Area Index (PDAI) [ Time Frame: 15 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pemphigoid Activity Score [ Time Frame: 8 weeks ]
- anti-BP180 antibody titers [ Time Frame: 8 weeks ]
- Oral Steroid dose [ Time Frame: 8 weeks ]
Original Secondary Outcome: Same as current
Information By: Nihon Pharmaceutical Co., Ltd
Dates:
Date Received: July 27, 2011
Date Started: August 2011
Date Completion:
Last Updated: October 15, 2013
Last Verified: October 2013
