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NCT04193592: PEARL
Efficacy and Safety of Pirfenidone Treatment in HPS-ILD
Phase 2 trial testing Pirfenidone in Hermansky Pudlak Syndrome in 50 participants. Status unknown.
31 December 2022
Quick facts
| Lead sponsor | Jesse Roman |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 December 2019 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 2 locations across Puerto Rico, United States |
Drugs / interventions tested
- Pirfenidone — full drug profile →
Conditions studied
- Hermansky Pudlak Syndrome — all drugs for Hermansky Pudlak Syndrome →
- Interstitial Lung Disease — all drugs for Interstitial Lung Disease →
Sponsor
Jesse Roman
Who can join
Adults 18 to 75, any sex, with Hermansky Pudlak Syndrome or Interstitial Lung Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This research study will explore the safety and efficacy of the drug, pirfenidone, in patients with a diagnosis of Hermansky-Pudlak Syndrome (HPS) who have an associated interstitial lung disease (ILD) over a planned period of 56 weeks.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy of Pirfenidone and Nintedanib in Interstitial Lung Diseases Other than Idiopathic Pulmonary Fibrosis: A Systematic Review.
Amati F, Stainer A, Polelli V, Mantero M, et al · · 2023 · cited 45× · PMID 37175556 · DOI 10.3390/ijms24097849 -
Hermansky-Pudlak Syndrome: An unusual pattern of pulmonary fibrosis.
Donnan M, Ellis S, Glaspole I. · · 2024 · cited 1× · PMID 39398874 · DOI 10.1016/j.rmcr.2024.102123
Verify or expand the search:
- PubMed search for NCT04193592
- 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
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 NCT04193592 (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 Jesse Roman
- Last refreshed: 10 December 2019
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/NCT04193592.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing