Clinical Trial of NPB-01 in Patients With Bullous Pemphig... | NCT00809822

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

NCT00809822

Sponsor

Nihon Pharmaceutical Co., Ltd

Status

Completed

Last Update Posted

Oct 25, 2010Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Bullous Pemphigoid

Interventions

NPB-01
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Dec 11, 2008

First Submission Date that Met QC Criteria

Dec 16, 2008

First Posted Date

Dec 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2010

Last Update Posted Date

Oct 25, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Intravenous immunoglobulin	Drug: NPB-01
2	Placebo Comparator	Physiological saline	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NPB-01	Drug	Intravenous immunoglobulin	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		57 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012872	Skin Diseases, Vesiculobullous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases