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Trial record 2 of 2 for:    "Bullous Pemphigoid" | "Immunoglobulins, Intravenous"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01408550
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : October 16, 2013
Sponsor:
Information provided by:
Nihon Pharmaceutical Co., Ltd

Tracking Information
First Submitted Date  ICMJE July 27, 2011
First Posted Date  ICMJE August 3, 2011
Last Update Posted Date October 16, 2013
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
The score using Pemphigus Disease Area Index (PDAI) [ Time Frame: 15 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01408550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids
Official Title  ICMJE NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignment Study(Phase III)
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bullous Pemphigoid
Intervention  ICMJE
  • Drug: NPB-01
    Intravenous immunoglobulin
  • Drug: Placebo
    Physiological saline
Study Arms  ICMJE
  • Active Comparator: NPB-01
    Active Comparator: 1 Intravenous immunoglobulin
    Intervention: Drug: NPB-01
  • Placebo Comparator: Placebo
    Placebo Comparator: 2 Physiological saline
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 2, 2011)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01408550
Other Study ID Numbers  ICMJE NPB-01-06/C-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nihon Pharmaceutical Co., Ltd, Clinical Development Department
Study Sponsor  ICMJE Nihon Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nihon Pharmaceutical Co., Ltd
Verification Date October 2013

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