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

NCT ID: NCT01408550

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Bullous Pemphigoid

Keywords

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IVIG in pemphigoid Patients with bullous pemphigoid unresponsive to corticosteroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NPB-01

Active Comparator: 1 Intravenous immunoglobulin

Group Type ACTIVE_COMPARATOR

NPB-01

Intervention Type DRUG

Intravenous immunoglobulin

Placebo

Placebo Comparator: 2 Physiological saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Physiological saline

Interventions

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NPB-01

Intravenous immunoglobulin

Intervention Type DRUG

Placebo

Physiological saline

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nihon Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Clinical Development Department

Locations

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Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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NPB-01-06/C-01

Identifier Type: -

Identifier Source: org_study_id