Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mycophenolate for Pulmonary Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00262132
Recruitment Status : Terminated
First Posted : December 6, 2005
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE December 5, 2005
First Posted Date  ICMJE December 6, 2005
Last Update Posted Date June 18, 2018
Study Start Date  ICMJE September 2003
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mycophenolate for Pulmonary Sarcoidosis
Official Title  ICMJE Mycophenolate for Pulmonary Sarcoidosis
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 beneficial to find an alternative agent to corticosteroids for the treatment of pulmonary sarcoidosis. This study is an open label trial of mycophenolate for new onset pulmonary sarcoidosis. Patients are candidates for this study if they have biopsy proven pulmonary sarcoidosis and a vital capacity or FEV1 less than 80% of predicted. Patients must undergo bronchoscopy where not only is the diagnosis of pulmonary sarcoidosis required, but in addition, cells are obtained from bronchoalveolar lavage. If the patients are diagnosed with pulmonary sarcoidosis, they are placed on an initial dose of 500mg BID of mycophenolate for 1 week. If their blood counts are not affected on this dose and they have no significant symptoms that are thought to be drug related, then their dose is escalated to 1g BID for the remaining 9 weeks of the study (the total study drug therapy time is 10 weeks). The patients are followed with multiple study visits. At these visits blood tests are drawn to make sure that there are no significant side effects from mycophenolate. In addition, the patients have a history and physical performed to evaluate the clinical state of their sarcoidosis and to detect mycophenolate side effects. On completion of 10 weeks of mycophenolate therapy, the patients undergo a second bronchoscopy with bronchoalveolar lavage to obtain cells for analysis. The patients are evaluated with spirometry, measurements of shortness of breath (dyspnea), and a quality of life scale (SF36) at serial visits during their study. The primary endpoint of the study is improved, unchanged or worse FVC. It is hoped that this pilot study will suggest that mycophenolate is a reasonable treatment option for new onset pulmonary sarcoidosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Pulmonary Sarcoidosis
Intervention  ICMJE Drug: Mycophenolate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: December¬†5,¬†2005)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00262132
Other Study ID Numbers  ICMJE CEL401
HR 11031
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Principal Investigator: Marc A Judson, MD Medical University of South Carolina
Study Chair: Don C Rockey, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP