Status:
TERMINATED
Mycophenolate for Pulmonary Sarcoidosis
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Pulmonary Sarcoidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Corticosteroids are presently the drug of choice for the treatment of pulmonary sarcoidosis. However, corticosteroids are associated with many significant side effects. For this reason, it would be be...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- New acute pulmonary sarcoidosis defined as a FVC or FEV1 less than 80 percent of predicted plus symptoms of worsening dyspnea, cough, chest pain, or wheezing in patients without a prior history of pulmonary sarcoidosis. All such patients will also require bronchoscopy with transbronchial biopsy that demonstrates noncaseating granulomas of unknown cause. Such patients are usually treated for acute pulmonary sarcoidosis. The transbronchial biopsy specimens must have negative stains for mycobacteria and fungi.
- \> 18 years of age
- Signing a written informed consent form.
- Exclusion Criteria
- Previous history of an adverse reaction to mycophenolate.
- Current use of another immunosuppressive medication.
- History of active hepatitis or another significant liver disease with the exception of proven or presumed sarcoidosis of the liver.
- Previous history of skin cancer
- Active peptic ulcer disease
- Pregnant and/ or lactating female
- Serum creatinine \> 2.0 mg/dl
- Serum bilirubin \> 3.0 mg/dl
- WBC \< 4,000/cu mm3
- Has demonstrated non-compliance in the past
- Current alcohol or drug abuse
- Evidence of significant sarcoidosis in extrapulmonary organs that requires therapy such that the mycophenolate doses could not be tapered if the pulmonary sarcoidosis was stable or improved.
- History of previous severe digestive system disease
- Patients taking azathioprine
- Patients taking cholestyramine or other drugs that affect enterohepatic recirculation
- Patients with Lesch-Nyhan or Kelley-Seegmiller syndrome
- Patients be willing not to receive live vaccines during the study
- Patients with phenylketonuria
- Patients with elevated serum transaminases or total bilirubin at baseline
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00262132
Start Date
September 1 2003
End Date
August 1 2006
Last Update
June 18 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425