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Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids. (NPB-01)

Primary Purpose

Bullous Pemphigoid

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
NPB-01
Placebo
Sponsored by
Nihon Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bullous Pemphigoid focused on measuring IVIG in pemphigoid, Patients with bullous pemphigoid unresponsive to corticosteroids

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Intravenous immunoglobulin

Physiological saline

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
December 11, 2008
Last Updated
October 21, 2010
Sponsor
Nihon Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00809822
Brief Title
Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids.
Acronym
NPB-01
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 Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nihon Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullous Pemphigoid
Keywords
IVIG in pemphigoid, Patients with bullous pemphigoid unresponsive to corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Intravenous immunoglobulin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Physiological saline
Intervention Type
Drug
Intervention Name(s)
NPB-01
Intervention Description
Intravenous immunoglobulin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Physiological saline
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with corticosteroids over 20mg/day(Prednisolone) at informed consent. Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent. Patients who pemphigoid activity score is score1 and more before study medication received. Patients who symptom is not improve before study medication received. Patients with twenty years old at informed consent. Patients with hospitalization during five consecutive days of study medication. Exclusion Criteria: Patients treated with plasmapheresis at 28 days before informed consent. Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent. Patients treated with intravenous immunoglobulin at 56 days before informed consent. Patients who receive or adjust in increments immunosuppressants at 14 days before informed consent. Patients with malignancy or a history of this disease. Patients with history of shock for NPB-01. Patients with history of hypersensitivity for NPB-01. Patients with IgA deficiency. Patients with impaired liver function. Patients with impaired renal function. Patients with cerebro- or cardiovascular disorders. Patients with high risk of thromboembolism. Patients with hemolytic/hemorrhagic anemia. Patients with decreased cardiac function. Patients with decreased platelet.
Facility Information:
City
Osaka
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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