Clinical trial • Phase II | Phase IV • Respiratory
METHYLPREDNISOLONE HYDROGEN SUCCINATE for Idiopathic pulmonary fibrosis | Acute exacerbation of idiopathic pulmonary fibrosis
Phase II | Phase IV trial of METHYLPREDNISOLONE HYDROGEN SUCCINATE for Idiopathic pulmonary fibrosis | Acute exacerbation of idiopathic pulmonary fibrosis.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Idiopathic pulmonary fibrosis | Acute exacerbation of idiopathic pulmonary fibrosis
- Trial Stage
- Phase II | Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-09-2024
- First CTIS Authorization Date
- 05-11-2024
Trial design
Randomised, placebo arms: sucrose octaacetate [nf] (placebo) and sodium chloride (saline solution; infusion route, maxdailydoseamount 100 ml, maxtotaldoseamount 300 ml).-controlled Phase II | Phase IV trial in France.
- Randomised
- Yes
- Comparator
- Placebo arms: Sucrose octaacetate [NF] (placebo) and SODIUM CHLORIDE (saline solution; infusion route, maxDailyDoseAmount 100 ml, maxTotalDoseAmount 300 ml).
- Target Sample Size
- 110
- Trial Duration For Participant
- 90
Eligibility
Recruits 110 Vulnerable population considerations: the trial includes vulnerable adult patients (isVulnerablePopulationSelected = true). The consent approach states: "Patient able to understand and sign a written informed consent form or in case of incapacity of the patient to a relative whom understand and sign a written informed consent form". Patients under tutorship/curatorship, deprived of liberty, or under court protection are explicitly excluded. A representative informed consent form is provided (L1 SIS and ICF Representative)..
- Pregnancy Exclusion
- Documented pregnancy or lactation
- Vulnerable Population
- Vulnerable population considerations: the trial includes vulnerable adult patients (isVulnerablePopulationSelected = true). The consent approach states: "Patient able to understand and sign a written informed consent form or in case of incapacity of the patient to a relative whom understand and sign a written informed consent form". Patients under tutorship/curatorship, deprived of liberty, or under court protection are explicitly excluded. A representative informed consent form is provided (L1 SIS and ICF Representative).
Inclusion criteria
- {"criterion_text":"- Patient is ≥ 18 years of age"}
- {"criterion_text":"- IPF or IPF (likely) diagnosis defined on 2018 international recommendations"}
- {"criterion_text":"- Definite or suspected Acute Exacerbation defined by the international working group criteria after exclusion of alternative diagnoses of acute worsening"}
- {"criterion_text":"- For women of childbearing age: efficient contraception for the duration of the study"}
- {"criterion_text":"- Affiliation to the social security"}
- {"criterion_text":"- Patient able to understand and sign a written informed consent form or in case of incapacity of the patient to a relative whom understand and sign a written informed consent form"}
Exclusion criteria
- {"criterion_text":"- Identified etiology for acute worsening (i.e.: infectious disease)"}
- {"criterion_text":"- Patient under tutorship or curatorship"}
- {"criterion_text":"- Patient deprived of liberty"}
- {"criterion_text":"- Patient under court protection"}
- {"criterion_text":"- Known hypersensitivity to glucocorticoids or to any component of the study treatment"}
- {"criterion_text":"- Patient requiring mechanical ventilation or already on mechanical ventilation"}
- {"criterion_text":"- Active bacterial, viral, fungal or parasitic infection. On swab collected, only positive for SARS-CoV-2, Influenzae A, Influenzae B and Respiratory Syncytial Virus (RSV) result, are considered active viral infection. The others viruses (i.e. Rhinovirus, Adenovirus…) are not considered to be responsible of pneumonia."}
- {"criterion_text":"- Active cancer"}
- {"criterion_text":"- Patient on a lung transplantation waiting list"}
- {"criterion_text":"- Treatment with glucocorticoids > 0.5 mg/kg/j for 3 consecutive days in the last 15 days OR treatment with glucocorticoids > 2 mg/kg/j for 3 consecutive days in the last 30 days Patient treated with long-term glucocorticoids ≤ 10mg/j for symptom management are eligible."}
- {"criterion_text":"- Patient participating to another interventional clinical trial"}
- {"criterion_text":"- Documented pregnancy or lactation"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Parameter: all-cause mortality rate; Timetable: Day 30.","definition_or_measurement_approach":"All-cause mortality at Day 30; measured as the all-cause mortality rate at Day 30."}
Secondary endpoints
- {"endpoint_text":"- vital status assessment at Day 30 and Day 90 with time (in days) between randomization and death","definition_or_measurement_approach":"Assessment of vital status at Day 30 and Day 90; time in days from randomization to death."}
- {"endpoint_text":"- Overall mortality at Day 90","definition_or_measurement_approach":"Overall mortality rate measured at Day 90."}
- {"endpoint_text":"- Death or transplantation at Day 90","definition_or_measurement_approach":"Combined endpoint of death or transplantation assessed at Day 90."}
- {"endpoint_text":"- Mortality linked to the respiratory disease at Day 30 and Day 90","definition_or_measurement_approach":"Respiratory-disease-specific mortality at Day 30 and Day 90."}
- {"endpoint_text":"- Time (in days) from randomization to worsening","definition_or_measurement_approach":"Time in days between randomization and clinical worsening."}
- {"endpoint_text":"- percentage of patients admitted to ICU","definition_or_measurement_approach":"Proportion of randomized patients admitted to intensive care unit."}
- {"endpoint_text":"- Percentage of patients requiring invasive ventilation","definition_or_measurement_approach":"Proportion of patients requiring invasive mechanical ventilation."}
- {"endpoint_text":"- length of hospital-stay","definition_or_measurement_approach":"Duration of hospital stay measured in days."}
- {"endpoint_text":"- Progression of pulmonary fibrosis","definition_or_measurement_approach":"Radiological evolution/progression of pulmonary fibrosis as assessed by imaging."}
- {"endpoint_text":"- Absolute change in percent Forced Vital Capacity and DLCO","definition_or_measurement_approach":"Change from baseline in percent predicted FVC and DLCO."}
- {"endpoint_text":"- Infectious disease","definition_or_measurement_approach":"Occurrence of infectious disease events (reported infections)."}
- {"endpoint_text":"- Capillary blood glucose monitoring and/or fasting blood glucose daily from D1 to hospital withdraw, discharge hospital visit, Day 30, Day 90","definition_or_measurement_approach":"Capillary or fasting blood glucose measurements daily during hospitalization and at discharge, Day 30 and Day 90."}
- {"endpoint_text":"- Cardiovascular disorder ( heart rate, blood pressure, clinical history daily)","definition_or_measurement_approach":"Daily monitoring of heart rate, blood pressure and cardiovascular clinical history/events."}
- {"endpoint_text":"- Neuropsychological disturbances","definition_or_measurement_approach":"Assessment and reporting of neuropsychological adverse events/disturbances."}
- {"endpoint_text":"- Clinical laboratory evaluation (blood count, serum chemistries and creatinin measurement)","definition_or_measurement_approach":"Laboratory assessments including blood count, serum chemistries and creatinine measurements."}
- {"endpoint_text":"- Dyspnea evaluation","definition_or_measurement_approach":"Evaluation of dyspnea using clinical scales."}
- {"endpoint_text":"- Hospital Anxiety and Depression Scale (HADs)","definition_or_measurement_approach":"Assessment of anxiety and depression using the HADS questionnaire."}
- {"endpoint_text":"- 7-category ordinal scale at day 15","definition_or_measurement_approach":"Clinical status at Day 15 assessed on a 7-category ordinal scale."}
Recruitment
- Planned Sample Size
- 110
- Recruitment Window Months
- 24
- Consent Approach
- Adults provide written informed consent. If the patient lacks capacity, a relative may understand and sign a written informed consent form on the patient's behalf. Representative informed consent forms are provided (L1 SIS and ICF Representative). Specific languages of documents are not specified in the available data.
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 110
France
- Earliest CTIS Part Ii Submission Date
- 18-10-2024
- Latest Decision Or Authorization Date
- 04-08-2025
- Processing Time Days
- 290
- Number Of Sites
- 29
- Number Of Participants
- 110
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- pneumology
- Principal Investigator Name
- Bruno Crestani
- Principal Investigator Email
- brunon.crestani@aphp.fr
- Contact Person Name
- Bruno Crestani
- Contact Person Email
- brunon.crestani@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Pneumologie
- Principal Investigator Name
- Stéphanie DIROU
- Principal Investigator Email
- stephanie.dirou@chu-nantes.Fr
- Contact Person Name
- Stéphanie DIROU
- Contact Person Email
- stephanie.dirou@chu-nantes.Fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- pneumology
- Principal Investigator Name
- Vincent COTTIN
- Principal Investigator Email
- vincent.cottin@chu-lyon.fr
- Contact Person Name
- Vincent COTTIN
- Contact Person Email
- vincent.cottin@chu-lyon.fr
- Site Name
- Centre Hospitalier Regional Universitaire
- Department Name
- pneumology
- Principal Investigator Name
- Mathilde DUPREZ
- Principal Investigator Email
- mduprez@chu-besancon.fr
- Contact Person Name
- Mathilde DUPREZ
- Contact Person Email
- mduprez@chu-besancon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- pneumology
- Principal Investigator Name
- Abdellatif TAZI
- Principal Investigator Email
- abdellatif.tazi@aphp.fr
- Contact Person Name
- Abdellatif TAZI
- Contact Person Email
- abdellatif.tazi@aphp.fr
- Site Name
- Hospital Foch
- Department Name
- respiratory disease
- Principal Investigator Name
- Alexandre CHABROL
- Principal Investigator Email
- A.chabrol@hopital-foch.com
- Contact Person Name
- Alexandre CHABROL
- Contact Person Email
- A.chabrol@hopital-foch.com
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Pneumology
- Principal Investigator Name
- Elodie BLANCHARD
- Principal Investigator Email
- elodie.blanchard@chu-bordeaux.Fr
- Contact Person Name
- Elodie BLANCHARD
- Contact Person Email
- elodie.blanchard@chu-bordeaux.Fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Pneumology
- Principal Investigator Name
- Camille ROLLAND-DEBORD
- Principal Investigator Email
- crollanddebord@chu-clermontferrand.fr
- Contact Person Name
- Camille ROLLAND-DEBORD
- Contact Person Email
- crollanddebord@chu-clermontferrand.fr
- Site Name
- CHRU De Nancy
- Department Name
- pneumology
- Principal Investigator Name
- anne GUILLAUMOT
- Principal Investigator Email
- a.guillaumot@chru-nancy.fr
- Contact Person Name
- anne GUILLAUMOT
- Contact Person Email
- a.guillaumot@chru-nancy.fr
- Site Name
- Hopital Tenon
- Department Name
- pneumology
- Principal Investigator Name
- Jacques CADRANEL
- Principal Investigator Email
- jacques.cadranel@aphp.fr
- Contact Person Name
- Jacques CADRANEL
- Contact Person Email
- jacques.cadranel@aphp.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- respiratory and sleep medicine
- Principal Investigator Name
- Frédéric GAGNADOUX
- Principal Investigator Email
- fgagnadoux@chu-angers.fr
- Contact Person Name
- Frédéric GAGNADOUX
- Contact Person Email
- fgagnadoux@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Respiratory disease
- Principal Investigator Name
- Arnaud BOURDIN
- Principal Investigator Email
- a-bourdin@chu-montpellier
- Contact Person Name
- Arnaud BOURDIN
- Contact Person Email
- a-bourdin@chu-montpellier
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- respiratory disease
- Principal Investigator Name
- François LEBARGY
- Principal Investigator Email
- flebardy@chu-reims.fr
- Contact Person Name
- François LEBARGY
- Contact Person Email
- flebardy@chu-reims.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Pneummology
- Principal Investigator Name
- Emmanuel BERGOT
- Principal Investigator Email
- bergot-e@chu-caen.fr
- Contact Person Name
- Emmanuel BERGOT
- Contact Person Email
- bergot-e@chu-caen.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pulmonary
- Principal Investigator Name
- David MONTANI
- Principal Investigator Email
- david.montani@aphp.fr
- Contact Person Name
- David MONTANI
- Contact Person Email
- david.montani@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Pneumology, thoracic oncology, allergology and respiratory care
- Principal Investigator Name
- Sylvie Leroy
- Principal Investigator Email
- leroy.s2@chu-nice.fr
- Contact Person Name
- Sylvie Leroy
- Contact Person Email
- leroy.s2@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- pneumology
- Principal Investigator Name
- Sebastien QUETANT
- Principal Investigator Email
- squentant@chu-grenoble.fr
- Contact Person Name
- Sebastien QUETANT
- Contact Person Email
- squentant@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- pneumology
- Principal Investigator Name
- Stéphane DOMINIQUE
- Principal Investigator Email
- stephane.dominique@chu-rouen.fr
- Contact Person Name
- Stéphane DOMINIQUE
- Contact Person Email
- stephane.dominique@chu-rouen.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- pneumology
- Principal Investigator Name
- Tristan DEGOT
- Principal Investigator Email
- tristan.degot@chru-strasbourg.fr
- Contact Person Name
- Tristan DEGOT
- Contact Person Email
- tristan.degot@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumology
- Principal Investigator Name
- Jean PASTRE
- Principal Investigator Email
- jean.pastre@aphp.fr
- Contact Person Name
- Jean PASTRE
- Contact Person Email
- jean.pastre@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- pneumology
- Principal Investigator Name
- Grégoire PREVOT
- Principal Investigator Email
- prevot.g@chu-toulouse.fr
- Contact Person Name
- Grégoire PREVOT
- Contact Person Email
- prevot.g@chu-toulouse.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Pneumology
- Principal Investigator Name
- Thomas FLAMENT
- Principal Investigator Email
- t.flament@chu.tours.Fr
- Contact Person Name
- Thomas FLAMENT
- Contact Person Email
- t.flament@chu.tours.Fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- pulmonology
- Principal Investigator Name
- Victor Valentin
- Principal Investigator Email
- victor.valentin@chu-lille.fr
- Contact Person Name
- Victor Valentin
- Contact Person Email
- victor.valentin@chu-lille.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Pneumology
- Principal Investigator Name
- quentin GIBIOT
- Principal Investigator Email
- quentin.gibiot@chicreteil.fr
- Contact Person Name
- quentin GIBIOT
- Contact Person Email
- quentin.gibiot@chicreteil.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- pulmonary disease
- Principal Investigator Name
- Martine REYNAUD GAUBERT
- Principal Investigator Email
- martinelouise.reynaud@ap-hm.fr
- Contact Person Name
- Martine REYNAUD GAUBERT
- Contact Person Email
- martinelouise.reynaud@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- pulmonoly and respiratory intensive care
- Principal Investigator Name
- philippe BONNIAUD
- Principal Investigator Email
- philippe.bonniaud@chu-dijon.fr
- Contact Person Name
- philippe BONNIAUD
- Contact Person Email
- philippe.bonniaud@chu-dijon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- pneumology
- Principal Investigator Name
- Hilario NUNES
- Principal Investigator Email
- hilario.nunes@aphp.Fr
- Contact Person Name
- Hilario NUNES
- Contact Person Email
- hilario.nunes@aphp.Fr
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- Pneumology
- Principal Investigator Name
- Jean Marc NACCACHE
- Principal Investigator Email
- jmnaccache@ghpsj.fr
- Contact Person Name
- Jean Marc NACCACHE
- Contact Person Email
- jmnaccache@ghpsj.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- pneumology
- Principal Investigator Name
- Stéphane JOUNEAU
- Principal Investigator Email
- stephane.jouneau@chu-rennes.fr
- Contact Person Name
- Stéphane JOUNEAU
- Contact Person Email
- stephane.jouneau@chu-rennes.fr
Sponsor
Primary sponsor
- Full Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- METHYLPREDNISOLONE VIATRIS 1 g, poudre pour solution injectable (I.V.)
- Active Substance
- METHYLPREDNISOLONE HYDROGEN SUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Marketing authorisation present (34009 355 406 4 5)
- Maximum Dose
- maxDailyDoseAmount 1000 mg; maxTotalDoseAmount 3000 mg; maxTreatmentPeriod 3 days
- Investigational Product Name
- LIQUID PREDNISONE
- Active Substance
- PREDNISONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Sponsor product PRD11626966 (sponsor supplied product)
- Maximum Dose
- maxDailyDoseAmount 1 mg/kg; maxTotalDoseAmount 16 mg/kg; maxTreatmentPeriod 30 days
- Investigational Product Name
- SODIUM CHLORIDE
- Active Substance
- SODIUM CHLORIDE
- Modality
- Other (saline/placebo)
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- SUB12581MIG (scientific product EV code)
- Maximum Dose
- maxDailyDoseAmount 100 ml; maxTotalDoseAmount 300 ml; maxTreatmentPeriod 3 days
- Investigational Product Name
- Sucrose octaacetate [NF]
- Modality
- Other (placebo)
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