Status:
COMPLETED
Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Pemphigus Vulgaris
Eligibility:
All Genders
10-75 years
Phase:
PHASE2
Brief Summary
Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease with unknown etiology that affects mucosa and skin of patients with significant morbidity and mortality. The...
Detailed Description
The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone. Official Title: Randomized, Double-Blind, Placebo...
Eligibility Criteria
Inclusion
- Lesions clinically consistent with pemphigus vulgaris
- Diagnosis confirmed by histology in terms of acantholysis within past month
- Positive DIF
Exclusion
- Any nursing or pregnant woman
- Any history of chronic diseases including liver disease, Chronic Renal Failure, Chronic Heart Failure or Ischemic Heart Disease
- Present diagnosis of hepatitis confirmed by serology or elevated hepatic enzymes;
- Clinically significant concurrent medical disease or laboratory abnormalities evidenced by one or more of the following:
- Hepatobiliary AST or ALT ≥ 1.5 × upper limit of normal (ULN);alkaline phosphatase ≥ 1.5 × ULN; or, total bilirubin \> 90% of the ULN;
- Renal serum creatinine \> 1.5 mg/dL; or, significant proteinuria \> 2+ on urinary dip test;
- Hematologic hemoglobin \< 11 mg/dL; leukocytes \< 3.5 × 109/L; neutrophils \< 1.5 × 109/L; or, platelets \< 100 × 109/L; Presence of anemia, leukopenia or thrombocytopenia
- Any sign of patient's non-compliance
- Known hypersensitivity to study drugs, prednisone or azathioprine
- Participating in another clinical trial at the time of screening and enrollment
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00626678
Start Date
January 1 2008
End Date
September 1 2010
Last Update
November 30 2010
Active Locations (1)
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1
Department of Dermatology, Tehran University of Medical Sciences
Tehran, Tehran Province, Iran