Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids
This study is currently recruiting participants.
Verified March 2012 by Nihon Pharmaceutical Co., Ltd
Sponsor:
Nihon Pharmaceutical Co., Ltd
Information provided by:
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01408550
First received: July 27, 2011
Last updated: March 26, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bullous Pemphigoid |
Drug: NPB-01 Drug: Placebo |
Phase 3 |
| 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(Phase III) |
Resource links provided by NLM:
Further study details as provided by Nihon Pharmaceutical Co., Ltd:
Primary Outcome Measures:
- The score using Pemphigus Disease Area Index (PDAI) [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pemphigoid Activity Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- anti-BP180 antibody titers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Oral Steroid dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: NPB-01
Active Comparator: 1 Intravenous immunoglobulin
|
Drug: NPB-01
Intravenous immunoglobulin
|
|
Placebo Comparator: Placebo
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:
- Patients with corticosteroids over 0.4mg/kg/day(Prednisolone) at informed consent.
- Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
- Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more before study medication received.
- Patients who the score using Pemphigus Disease Area Index(PDAI) 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 and seven consecutive days after administration 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: NCT01408550
Locations
| Japan | |
| Recruiting | |
| Osaka, Japan | |
| Contact: Yasumasa Ogawa kaihatsu@nihon-pharm.co.jp | |
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
More Information
No publications provided
| Responsible Party: | Nihon Pharmaceutical Co., Ltd, Clinical Development Department |
| ClinicalTrials.gov Identifier: | NCT01408550 History of Changes |
| Other Study ID Numbers: | NPB-01-06/C-01 |
| Study First Received: | July 27, 2011 |
| Last Updated: | March 26, 2012 |
| 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 22, 2013