Pirfenidone for Progressive Fibrotic Sarcoidosis

NCT03260556 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 2016-5706
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis

Conditions

Sarcoidosis, Pulmonary

Keywords

pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• Time until clinical worsening (TCW)

  TCW

  two years

Secondary Outcomes (2)

• Change in forced vital capacity (FVC)

  two years

• Change in CPI

  two years

Study Arms (2)

Pirfenidone

ACTIVE COMPARATOR

Pirfenidone titrated to three 267 mg tablets three times a day

Drug: Pirfenidone

Placebos

PLACEBO COMPARATOR

Placebo titrated to three tablets three times a day

Drug: Placebos

Interventions

Pirfenidone DRUG

Increasing doses

Also known as: esbriet

Pirfenidone

Placebos DRUG

Increasing doses

Also known as: placebo

Placebos

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

MeSH Terms

Conditions

Sarcoidosis, Pulmonary; Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert P Baughman, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert P Baughman, MD

CONTACT

513-584-5225; baughmrp@ucmail.uc.edu

Rebecca Reeves

CONTACT

513-584-5226; Rebecca.Klein@UCHealth.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blind placebo controlled trial

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: September 27, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 30, 2020
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

US (1)