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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03260556 |
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Date of registration:
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22/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pirfenidone for Progressive Fibrotic Sarcoidosis
PirFS |
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Scientific title:
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Pirfenidone for Progressive Fibrotic Sarcoidosis |
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Date of first enrolment:
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September 27, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03260556 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert P Baughman, MD |
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Address:
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Telephone:
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513-584-5225 |
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Email:
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baughmrp@ucmail.uc.edu |
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Affiliation:
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Name:
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Robert P Baughman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cincinnati |
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Name:
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Robert P Baughman, MD |
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Address:
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Telephone:
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513-584-5225 |
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Email:
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bob.baughman@uc.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of sarcoidosis
- Pulmonary function testing with a Composite Physiologic Index (CPI) score of greater
than 40
- Patient must have evidence of >20% fibrosis on high resolution cat scan
- Patients must be on a stable prednisone therapy for sarcoidosis for at least two
months and no change in other immunosuppressives in the two months prior to entry into
study
- Age greater than 18 and less than 90.
- Able to provide written informed consent for participation in the study
Exclusion Criteria:
- Patients receiving therapy for precapillary pulmonary hypertension.
- Patients with liver disease Childs class 3 or 4
- Patients with a left ventricular ejection fraction of less than 40%
- Patients receiving more than 20 mg prednisone daily or its equivalent
- Patients with massive hemoptysis within prior three months. Patients with mycetomas
are eligible as long as no massive hemoptysis in prior three months.
- Patients with clinically important co-existing disease which in the opinion of the
investigator is likely to affect patient's chance for survival during the course of
the study
- Patient who is pregnant, lactating, intending to become pregnant during the study, or
child bearing capacity who is not willing to use appropriate birth control methods
approved by investigator
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sarcoidosis, Pulmonary
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Intervention(s)
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Drug: Placebos
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Drug: Pirfenidone
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Primary Outcome(s)
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Time until clinical worsening (TCW)
[Time Frame: two years]
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Secondary Outcome(s)
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Change in forced vital capacity (FVC)
[Time Frame: two years]
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Change in CPI
[Time Frame: two years]
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Secondary ID(s)
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2016-5706
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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