Recruiting

Pirfenidone

Sponsor:

University of Cincinnati

Code:

NCT03260556

Conditions

Sarcoidosis, Pulmonary

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pirfenidone

Placebos

Study Details

Brief summary:

Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis

Conditions

Sarcoidosis, Pulmonary

Study ID

NCT03260556

Start date

Sep 27, 2017

Status verified date

Sep, 2017

Completion date

Mar 30, 2020

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pirfenidone

Pirfenidone titrated to three 267 mg tablets three times a day

placebo comparator: Placebos

Placebo titrated to three tablets three times a day

Interventions

Pirfenidone

Increasing doses

Placebos

Increasing doses

Primary outcome measure

  • Time until clinical worsening (TCW) [ Time Frame: two years ]

Central Contacts and Locations

Central contacts

Robert P Baughman, MD

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

Rebecca Reeves

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

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Robert P Baughman, MD

513-584-5225bob.baughman@uc.edu

Elyse E Lower

513-584-3829ELower@ucmail.uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

Sep 28, 2017

Last verified

Sep, 2017

Keywords

  • pulmonary fibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2017-09-28.