Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids

This study has been completed.
Sponsor:
Information provided by:
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01408550
First received: July 27, 2011
Last updated: October 15, 2013
Last verified: October 2013

July 27, 2011
October 15, 2013
August 2011
September 2013   (final data collection date for primary outcome measure)
The score using Pemphigus Disease Area Index (PDAI) [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01408550 on ClinicalTrials.gov Archive Site
  • Pemphigoid Activity Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • anti-BP180 antibody titers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Oral Steroid dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids
NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignment Study(Phase III)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Bullous Pemphigoid
  • Drug: NPB-01
    Intravenous immunoglobulin
  • Drug: Placebo
    Physiological saline
  • Active Comparator: NPB-01
    Active Comparator: 1 Intravenous immunoglobulin
    Intervention: Drug: NPB-01
  • Placebo Comparator: Placebo
    Placebo Comparator: 2 Physiological saline
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with corticosteroids over 0.4mg/kg/day(Prednisolone) at informed consent.
  2. Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
  3. Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more before study medication received.
  4. Patients who the score using Pemphigus Disease Area Index(PDAI) is not improve before study medication received.
  5. Patients with twenty years old at informed consent.
  6. Patients with hospitalization during five consecutive days of study medication and seven consecutive days after administration of study medication .

Exclusion Criteria:

  1. Patients treated with plasmapheresis at 28 days before informed consent.
  2. Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent.
  3. Patients treated with intravenous immunoglobulin at 56 days before informed consent.
  4. Patients who receive or adjust in increments immunosuppressants at 14 days before informed consent.
  5. Patients with malignancy or a history of this disease.
  6. Patients with history of shock for NPB-01.
  7. Patients with history of hypersensitivity for NPB-01.
  8. Patients with IgA deficiency.
  9. Patients with impaired liver function.
  10. Patients with impaired renal function.
  11. Patients with cerebro- or cardiovascular disorders.
  12. Patients with high risk of thromboembolism.
  13. Patients with hemolytic/hemorrhagic anemia.
  14. Patients with decreased cardiac function.
  15. Patients with decreased platelet.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01408550
NPB-01-06/C-01
No
Nihon Pharmaceutical Co., Ltd, Clinical Development Department
Nihon Pharmaceutical Co., Ltd
Not Provided
Not Provided
Nihon Pharmaceutical Co., Ltd
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP