- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00262132
Mycophenolate for Pulmonary Sarcoidosis
Study Overview
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Lung Diseases
- Lung Diseases, Interstitial
- Sarcoidosis, Pulmonary
- Sarcoidosis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Mycophenolic Acid
Other Study ID Numbers
- CEL401
- HR 11031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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