We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pirfenidone for Progressive Fibrotic Sarcoidosis (PirFS)

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: 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
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis

Condition or disease Intervention/treatment Phase
Sarcoidosis, Pulmonary Drug: Pirfenidone Drug: Placebos Phase 4

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind placebo controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Placebo controlled
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
Drug Information available for: Pirfenidone

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Pirfenidone
Pirfenidone titrated to three 267 mg tablets three times a day
 Drug: Pirfenidone
Increasing doses
Other Name: esbriet
Placebo Comparator: Placebos
Placebo titrated to three tablets three times a day
 Drug: Placebos
Increasing doses
Other Name: placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time until clinical worsening (TCW) [ Time Frame: two years ]
    TCW


Secondary Outcome Measures :
  1. Change in forced vital capacity (FVC) [ Time Frame: two years ]
    Change in forced vital capacity

  2. Change in CPI [ Time Frame: two years ]
    Change in composite physiologic index


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Robert P Baughman, MD 513-584-5225 baughmrp@ucmail.uc.edu
Contact: Rebecca Reeves 513-584-5226 Rebecca.Klein@UCHealth.com

Locations
Layout table for location information
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Robert P Baughman, MD    513-584-5225    bob.baughman@uc.edu   
Contact: Elyse E Lower    513-584-3829    ELower@ucmail.uc.edu   
Sponsors and Collaborators
University of Cincinnati
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Robert P Baughman, MD University of Cincinnati
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Robert P Baughman, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03260556    
Other Study ID Numbers: 2016-5706
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: no plans yet

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Robert P Baughman, University of Cincinnati:
pulmonary fibrosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Pirfenidone
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents