Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus

NCT00483119 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-02-18

Study results available
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Summary

The purpose of this study is to compare two standard treatments for pemphigus to determine which more effectively improves the clinical manifestations of the disease and decreases serum level of the autoantibodies which cause the disease.

Conditions

  • Pemphigus Vulgaris

Interventions

DRUG

intravenous immunoglobulin

Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles

DRUG

cyclophosphamide

cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration

Sponsors & Collaborators

Principal Investigators

  • Jean-Claude Bystryn, M.D. · NYU MEDICAL CENTER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483119 on ClinicalTrials.gov