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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:
NCT00809822
First received: December 11, 2008
Last updated: October 21, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Bullous Pemphigoid
 Drug: NPB-01
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignment Study(PhaseⅡ).

Resource links provided by NLM:

MedlinePlus related topics: Pemphigus Steroids
U.S. FDA Resources

Further study details as provided by Nihon Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intravenous immunoglobulin
 Drug: NPB-01
Intravenous immunoglobulin
Placebo Comparator: 2
Physiological saline
 Drug: Placebo
Physiological saline

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with corticosteroids over 20mg/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 pemphigoid activity score is score1 and more before study medication received.
  4. Patients who symptom 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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809822

Locations
Japan
Osaka, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Nihon Pharmaceutical Co., Ltd, Clinical Development Department
ClinicalTrials.gov Identifier: NCT00809822     History of Changes
Other Study ID Numbers: NPB-01-06/E-01
Study First Received: December 11, 2008
Last Updated: October 21, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nihon Pharmaceutical Co., Ltd:
IVIG in pemphigoid
Patients with bullous pemphigoid unresponsive to corticosteroids

Additional relevant MeSH terms:
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
 Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013