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

Sponsored by:	Nihon Pharmaceutical Co., Ltd
Information provided by:	Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:	NCT00809822

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 II

Drug Information available for: Immunoglobulins Globulin, Immune Sodium chloride Corticosteroids

U.S. FDA Resources

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

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:	December 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Intravenous immunoglobulin	Drug: NPB-01 Intravenous immunoglobulin
2: Placebo Comparator 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:

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.

Contacts and Locations

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

Locations

Japan
	Recruiting
Osaka, Japan
Contact: Yasumasa Ogawa kaihatsu@nihon-pharm.co.jp
Contact: Yasumasa Ogawa kaihatsu@nihon-pharm.co.jp

Sponsors and Collaborators

Nihon Pharmaceutical Co., Ltd

More Information

Responsible Party:	Clinical Development Department ( Nihon Pharmaceutical Co., Ltd )
Study ID Numbers:	NPB-01-06/E-01
Study First Received:	December 11, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809822
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

Study placed in the following topic categories:

Pemphigoid, Bullous
Antibodies
Autoimmune Diseases
Skin Diseases, Vesiculobullous
Skin Diseases

Immunoglobulins, Intravenous
Bullous pemphigoid
Rho(D) Immune Globulin
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009