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Pirfenidone for Progressive Fibrotic Sarcoidosis (PirFS)

Primary Purpose

Sarcoidosis, Pulmonary

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pirfenidone

Placebos

About this trial

This is an interventional treatment trial for Sarcoidosis, Pulmonary focused on measuring pulmonary fibrosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pirfenidone

Placebos

Arm Description

Pirfenidone titrated to three 267 mg tablets three times a day

Placebo titrated to three tablets three times a day

Outcomes

Primary Outcome Measures

Time until clinical worsening (TCW)

TCW

Secondary Outcome Measures

Change in forced vital capacity (FVC)

Change in forced vital capacity

Change in CPI

Change in composite physiologic index

Full Information

NCT ID

NCT03260556

First Posted

August 22, 2017

Last Updated

September 27, 2017

Sponsor

University of Cincinnati

Collaborators

Royal Brompton & Harefield NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT03260556

Brief Title

Pirfenidone for Progressive Fibrotic Sarcoidosis

Acronym

PirFS

Official Title

Pirfenidone for Progressive Fibrotic Sarcoidosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 27, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

Collaborators

Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoidosis, Pulmonary

Keywords

pulmonary fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Double blind placebo controlled trial

Masking

ParticipantCare ProviderInvestigator

Masking Description

Placebo controlled

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pirfenidone

Arm Type

Active Comparator

Arm Description

Pirfenidone titrated to three 267 mg tablets three times a day

Arm Title

Placebos

Arm Type

Placebo Comparator

Arm Description

Placebo titrated to three tablets three times a day

Intervention Type

Drug

Intervention Name(s)

Pirfenidone

Other Intervention Name(s)

esbriet

Intervention Description

Increasing doses

Intervention Type

Drug

Intervention Name(s)

Placebos

Other Intervention Name(s)

placebo

Intervention Description

Increasing doses

Primary Outcome Measure Information:

Title

Time until clinical worsening (TCW)

Description

TCW

Time Frame

two years

Secondary Outcome Measure Information:

Title

Change in forced vital capacity (FVC)

Description

Change in forced vital capacity

Time Frame

two years

Title

Change in CPI

Description

Change in composite physiologic index

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert P Baughman, MD

Phone

513-584-5225

baughmrp@ucmail.uc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Rebecca Reeves

Phone

513-584-5226

Rebecca.Klein@UCHealth.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert P Baughman, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert P Baughman, MD

Phone

513-584-5225

bob.baughman@uc.edu

First Name & Middle Initial & Last Name & Degree

Elyse E Lower

Phone

513-584-3829

ELower@ucmail.uc.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

no plans yet

Learn more about this trial

Pirfenidone for Progressive Fibrotic Sarcoidosis

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