Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00262132
Eligibility Criteria:
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
1. Previous history of an adverse reaction to mycophenolate.
2. Current use of another immunosuppressive medication.
3. History of active hepatitis or another significant liver disease with the exception of proven or presumed sarcoidosis of the liver.
4. Previous history of skin cancer
5. Active peptic ulcer disease
6. Pregnant and/ or lactating female
7. Serum creatinine \> 2.0 mg/dl
8. Serum bilirubin \> 3.0 mg/dl
9. WBC \< 4,000/cu mm3
10. Has demonstrated non-compliance in the past
11. Current alcohol or drug abuse
12. 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.
13. History of previous severe digestive system disease
14. Patients taking azathioprine
15. Patients taking cholestyramine or other drugs that affect enterohepatic recirculation
16. Patients with Lesch-Nyhan or Kelley-Seegmiller syndrome
17. Patients be willing not to receive live vaccines during the study
18. Patients with phenylketonuria
19. Patients with elevated serum transaminases or total bilirubin at baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00262132
Study Brief:
Protocol Section:
NCT00262132