2022
Long-term evaluation of the safety and efficacy of recombinant human pentraxin-2 (rhPTX-2) in patients with idiopathic pulmonary fibrosis (IPF): an open-label extension study
Raghu G, Hamblin MJ, Brown AW, Golden JA, Ho LA, Wijsenbeek MS, Vasakova M, Pesci A, Antin-Ozerkis DE, Meyer KC, Kreuter M, Burgess T, Kamath N, Donaldson F, Richeldi L. Long-term evaluation of the safety and efficacy of recombinant human pentraxin-2 (rhPTX-2) in patients with idiopathic pulmonary fibrosis (IPF): an open-label extension study. Respiratory Research 2022, 23: 129. PMID: 35597980, PMCID: PMC9123757, DOI: 10.1186/s12931-022-02047-0.Peer-Reviewed Original ResearchConceptsOpen-label extensionIdiopathic pulmonary fibrosisWeek 128PRM-151Serious TEAEsPulmonary fibrosisPentraxin 2Efficacy dataRandomized periodTreatment-emergent adverse event profilesOpen-label extension studyAcute respiratory failureAdverse event profileNew safety signalsPatient-reported outcomesLimited efficacy dataLong-term safetyEudraCT 2014Lung transplantationRespiratory failureWalk distanceLong-term evaluationEvent profileVital capacityIntravenous infusion
2019
Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study
Raghu G, van den Blink B, Hamblin MJ, Brown AW, Golden JA, Ho LA, Wijsenbeek MS, Vasakova M, Pesci A, Antin-Ozerkis DE, Meyer KC, Kreuter M, Moran D, Santin-Janin H, Aubin F, Mulder GJ, Gupta R, Richeldi L. Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study. The Lancet Respiratory Medicine 2019, 7: 657-664. PMID: 31122893, DOI: 10.1016/s2213-2600(19)30172-9.Peer-Reviewed Original ResearchConceptsOpen-label extension studyIdiopathic pulmonary fibrosisPRM-151Adverse eventsLong-term treatmentWalking distanceExtension studyIPF exacerbationsWeek 52Week 76Pulmonary fibrosisIPF progressionDouble-blind treatment periodLife-threatening adverse eventsDouble-blind periodExploratory efficacy analysesSerious adverse eventsSevere adverse eventsMin intravenous infusionLong-term safetyRandom intercept mixed modelChest painPlacebo groupMore patientsEfficacy analysis
2018
An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002)
Gotfried MH, Girod CE, Antin-Ozerkis D, Burgess T, Strombom I, Stauffer JL, Kirchgaessler KU, Padilla ML. An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002). Pulmonary Therapy 2018, 4: 59-71. PMID: 32026243, PMCID: PMC6967037, DOI: 10.1007/s41030-018-0053-y.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsIdiopathic pulmonary fibrosisPatient exposure yearsSerious treatment-emergent adverse eventsPulmonary fibrosisIPF progressionFrequent treatment-emergent adverse eventsUpper respiratory tract infectionSafety of pirfenidoneUse of pirfenidoneOpen-label studyPhase II studyGastroesophageal reflux diseaseNew safety signalsRespiratory tract infectionsOverall incidence rateLong-term safetyCumulative total exposureConcomitant prednisoneOpen labelReflux diseaseAdverse eventsII studyMaintenance doseMost patients