Pirfenidone for Progressive Fibrotic Sarcoidosis

Sarcoidosis, Pulmonary Clinical Trial

— PirFS  

Official title:

Pirfenidone for Progressive Fibrotic Sarcoidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03260556
• Other study ID #: 2016-5706
• Status: Recruiting
• Phase: Phase 4
• First received: August 22, 2017
• Last updated: September 27, 2017
• Start date: September 27, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: September 2017
• Source: University of Cincinnati
• Contact: Robert P Baughman, MD
• Phone: 513-584-5225
• Email: baughmrp[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Drug:
• Pirfenidone
Increasing doses
• Placebos
Increasing doses

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time until clinical worsening (TCW)	TCW	two years
Secondary	Change in forced vital capacity (FVC)	Change in forced vital capacity	two years
Secondary	Change in CPI	Change in composite physiologic index	two years