Pirfenidone for Progressive Fibrotic Sarcoidosis (PirFS)
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|ClinicalTrials.gov Identifier: NCT03260556|
Recruitment Status : Unknown
Verified September 2017 by Robert P Baughman, University of Cincinnati.
Recruitment status was: Recruiting
First Posted : August 24, 2017
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis, Pulmonary||Drug: Pirfenidone Drug: Placebos||Phase 4|
Patients who meet the inclusion and exclusion criteria will be randomized to be treated with either placebo or pirfenidone at the current approved dosage for idiopathic pulmonary fibrosis at a 2:1 pirfenidone to placebo ratio. Patients treated with pirfenidone will be titrated using the following schedule:
One 267 mg capsules three times a day for two weeks. Two 267 mg capsules three times a day for two weeks Three 267 mg capsules three times a day thereafter Patients will be instructed to take all doses of medication with food. Dosage will be titrated on an individual basis depending on patient tolerance of medication.
Those randomized to placebo will receive the same schedule using placebo tablets.
Block randomization will be done at each site. Liver function tests will be evaluated as listed above. If the patient has an abnormal liver function test, then the dose will be adjusted per the company's protocol for commercial drug.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind placebo controlled trial|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Placebo controlled|
|Official Title:||Pirfenidone for Progressive Fibrotic Sarcoidosis|
|Actual Study Start Date :||September 27, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 30, 2020|
Active Comparator: Pirfenidone
Pirfenidone titrated to three 267 mg tablets three times a day
Other Name: esbriet
Placebo Comparator: Placebos
Placebo titrated to three tablets three times a day
Other Name: placebo
- Time until clinical worsening (TCW) [ Time Frame: two years ]TCW
- Change in forced vital capacity (FVC) [ Time Frame: two years ]Change in forced vital capacity
- Change in CPI [ Time Frame: two years ]Change in composite physiologic index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260556
|Contact: Robert P Baughman, MDfirstname.lastname@example.org|
|Contact: Rebecca Reeves||513-584-5226||Rebecca.Klein@UCHealth.com|
|Principal Investigator:||Robert P Baughman, MD||University of Cincinnati|