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Trial record 1 of 2 for:    "Bullous Pemphigoid" | "Immunoglobulins, Intravenous"
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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
Sponsor:
Information provided by:
Nihon Pharmaceutical Co., Ltd

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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).
Study Start Date : November 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus Steroids

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Intravenous immunoglobulin
 Drug: NPB-01
Intravenous immunoglobulin
Placebo Comparator: 2
Physiological saline
 Drug: Placebo
Physiological saline


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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Japan
Osaka, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
More Information
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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
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010
Keywords provided by Nihon Pharmaceutical Co., Ltd:
IVIG in pemphigoid
Patients with bullous pemphigoid unresponsive to corticosteroids
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Skin Diseases, Vesiculobullous
Skin Diseases
 Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs