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NCT03260556: PirFS
Pirfenidone for Progressive Fibrotic Sarcoidosis
Phase 4 trial testing Pirfenidone in Sarcoidosis, Pulmonary in 60 participants. Status unknown.
31 December 2019
Quick facts
| Lead sponsor | University of Cincinnati |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 27 September 2017 |
| Primary completion | 31 December 2019 |
| Estimated completion | 30 March 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pirfenidone — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Sarcoidosis, Pulmonary — all drugs for Sarcoidosis, Pulmonary →
Sponsor
University of Cincinnati
Who can join
Adults 18 to 90, any sex, with Sarcoidosis, Pulmonary. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Progression of fibrosing interstitial lung disease.
Wong AW, Ryerson CJ, Guler SA. · · 2020 · cited 122× · PMID 31996266 · DOI 10.1186/s12931-020-1296-3 -
Antifibrotic therapy for fibrotic lung disease beyond idiopathic pulmonary fibrosis.
Collins BF, Raghu G. · · 2019 · cited 92× · PMID 31578210 · DOI 10.1183/16000617.0022-2019 -
Treatment of Sarcoidosis: A Multidisciplinary Approach.
Gerke AK. · · 2020 · cited 87× · PMID 33329511 · DOI 10.3389/fimmu.2020.545413 -
Pharmacological management of progressive-fibrosing interstitial lung diseases: a review of the current evidence.
Richeldi L, Varone F, Bergna M, de Andrade J, et al · · 2018 · cited 63× · PMID 30578333 · DOI 10.1183/16000617.0074-2018 -
Irreversibility of Pulmonary Fibrosis.
Yu QY, Tang XX. · · 2022 · cited 53× · PMID 35111363 · DOI 10.14336/ad.2021.0730 -
Refractory Sarcoidosis: A Review.
El Jammal T, Jamilloux Y, Gerfaud-Valentin M, Valeyre D, et al · · 2020 · cited 45× · PMID 32368072 · DOI 10.2147/tcrm.s192922 -
Comprehensive Care for Patients with Sarcoidosis.
Moor CC, Kahlmann V, Culver DA, Wijsenbeek MS. · · 2020 · cited 32× · PMID 32024123 · DOI 10.3390/jcm9020390 -
Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches.
Obi ON, Saketkoo LA, Russell AM, Baughman RP. · · 2022 · cited 31× · PMID 36314034 · DOI 10.3389/fmed.2022.991783
Verify or expand the search:
- PubMed search for NCT03260556
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pirfenidone
Trials testing the same drug.
- NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in · Phase 2 · recruiting
- NCT07082842 — Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF · Phase 3 · not yet recruiting
- NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in · Phase 1 · completed
- NCT06485635 — Real-life-persistence to Antifibrotic Treatments · completed
- NCT06484153 — Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcin · Phase 1, PHASE2 · not yet recruiting
Other recruiting trials for Sarcoidosis, Pulmonary
Currently open trials in the same condition.
- NCT05841758 — Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis · Phase 4 · recruiting
- NCT06479603 — RCT of Nintedanib in Fibrotic Sarcoidosis · Phase 4 · recruiting
- NCT05746039 — Feasibility of Semaglutide in Advanced Lung Disease · Phase 1, PHASE2 · recruiting
- NCT05291468 — the PHENOSAR Trial: Use of Antibiotics in Treatment of Sarcoidosis · NA · active not recruiting
- NCT05567133 — Risk Indicators of Sarcoidosis Evolution-Unified Protocol · recruiting
Other University of Cincinnati trials
Trials by the same sponsor.
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- NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03260556 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Cincinnati
- Last refreshed: 28 September 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03260556.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing