Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids. (NPB-01)
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|ClinicalTrials.gov Identifier: NCT00809822|
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : October 25, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Bullous Pemphigoid||Drug: NPB-01 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignment Study(PhaseⅡ).|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Active Comparator: 1
Placebo Comparator: 2
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809822