to evaluate a triple therapy: plasma exchange, rituximab, intravenous immunoglobulin (IVIg) and corticosteroid administration compared to standard corticosteroid therapy in patients for severe acute exacerbation of idiopathic pulmonary

Therapeutic plasma exchange, rituximab and intravenous immunoglobulins (IVIg) for severe acute exacerbation of idiopathic pulmonary fibrosis admitted in ICU: an open, randomized, controlled trial - EXCHANGE-IFP

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002632-24-FR

Enrollment

Registered

2018-07-20

Start date

2018-11-13

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe acute exacerbation of idiopathic pulmonary fibrosis

Interventions

Trade Name: RIXATHON 500 mg Pharmaceutical Form: Concentrate for solution for infusion Trade Name: PRIVIGEN 100mg/ml Pharmaceutical Form: Solution for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patient = 18 years of age and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Known hypersensitivity intravenous immunoglobulins or rituximab 2.Severe heart failure 3.Active and uncontrolled bacterial fungal or parasitic infection 4.Positive multiplex PCR for Influenzae A and B, and for VRS 5.Deep Veinous Thrombosis or Pulmonary embolism in the last six months 6.Prior exposures to human-murine chimeric antibodies 7.Ongoing treatment with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, etc.) 8.Subject treated with more than 2 boluses of methylprednisolone (total dose > 500mg of methylprednisolone) or one dose > 10mg/kg in the last 72 hours 9.Uncorrectable coagulopathies or thrombocytopenia < 30000/mm3 10.Active cancer (other than basal cell carcinoma of the skin) 11.Other source of immunosuppression (i.e. HIV infection, solid organ transplant, lymphoma or leukemia) 12.Pregnancy 13.Patient listed for lung transplantation 14.Patient on ECMO 15.Patient with a do-not-intubate order at admission to ICU 16.Concurrent participation in other experimental trials 17.Not Affiliation to the French social security 18.Not Written informed consent from the patient or a legal representative if appropriate

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to evaluate the impact on overall mortality at day 28 after initiation of plasma exchanges, rituximab, intravenous immunoglobulins (IVIg), and corticosteroid administration versus standard corticosteroid therapy in hypoxemic patients admitted in ICU for severe acute exacerbation of idiopathic pulmonary fibrosis with PaO2/FiO2 ratio below 200.; Secondary Objective: -To compare the overall mortality at day 90, at 6 months and at 12 months after the initiation of therapy -To compare the exposition to mechanical ventilation -To compare the length of ICU and hospital-stay -To compare the evolution of SOFA score -To compare the radiological evolution -To compare the evolution of lung injury biomarkers in serum -To compare the evolution of autoantibodies levels before and after therapy -To compare the evolution of blood fibrocytes proportions -To evaluate respiratory functional at 3months and compare data previously available -To assess the quality of life (SF36), autonomy (ADL) and muscle strength scores (MRC) at 3 months of inclusion -To compare the occurrence of healthcare-associated infection -To describe the specific complications associated to the experimental treatment ;Primary end point(s): the mortality rate from randomization to Day 28 after initiation of treatment.;Timepoint(s) of evaluation of this end point: end of the trial	—

Measure

Time frame

Main Objective: The main objective is to evaluate the impact on overall mortality at day 28 after initiation of plasma exchanges, rituximab, intravenous immunoglobulins (IVIg), and corticosteroid administration versus standard corticosteroid therapy in hypoxemic patients admitted in ICU for severe acute exacerbation of idiopathic pulmonary fibrosis with PaO2/FiO2 ratio below 200.; Secondary Objective: -To compare the overall mortality at day 90, at 6 months and at 12 months after the initiation of therapy -To compare the exposition to mechanical ventilation -To compare the length of ICU and hospital-stay -To compare the evolution of SOFA score -To compare the radiological evolution -To compare the evolution of lung injury biomarkers in serum -To compare the evolution of autoantibodies levels before and after therapy -To compare the evolution of blood fibrocytes proportions -To evaluate respiratory functional at 3months and compare data previously available -To assess the quality of life (SF36), autonomy (ADL) and muscle strength scores (MRC) at 3 months of inclusion -To compare the occurrence of healthcare-associated infection -To describe the specific complications associated to the experimental treatment ;Primary end point(s): the mortality rate from randomization to Day 28 after initiation of treatment.;Timepoint(s) of evaluation of this end point: end of the trial

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Secondary

Measure	Time frame
Secondary end point(s): 1.Overall mortality at day 90, at 6 months and at 12 months 2.Number of days alive without mechanical ventilation between day 1 and day 28 3.Length of ICU-stay and hospital-stay 4.Changes from D1 in SOFA score at D3, D7, D16, D21, D28 or discharge-day from ICU as appropriate (in case of death before D28, the last SOFA score collected will be 24 points) 5.Variation of global extent of HRCT infiltrates between initial HRCT and D90 according to Akira et al. [49] 6.Changes in lung injury biomarkers in serum (KL-6, SP-D) from D1 to D16, D21, D28 and D90 7.Changes in circulating autoantibodies levels (anti-periplakin, anti-HSP70 and anti-vimentin antibodies) from D1 to D28 and D90 8.Changes in the proportion of blood fibrocytes from D1 to D16, D28 and D90 9.Proportion of patients with at least one episode of any healthcare-associated infection between inclusion and D28 ;Timepoint(s) of evaluation of this end point: at the end of the trial	—

Measure

Time frame

Secondary end point(s): 1.Overall mortality at day 90, at 6 months and at 12 months 2.Number of days alive without mechanical ventilation between day 1 and day 28 3.Length of ICU-stay and hospital-stay 4.Changes from D1 in SOFA score at D3, D7, D16, D21, D28 or discharge-day from ICU as appropriate (in case of death before D28, the last SOFA score collected will be 24 points) 5.Variation of global extent of HRCT infiltrates between initial HRCT and D90 according to Akira et al. [49] 6.Changes in lung injury biomarkers in serum (KL-6, SP-D) from D1 to D16, D21, D28 and D90 7.Changes in circulating autoantibodies levels (anti-periplakin, anti-HSP70 and anti-vimentin antibodies) from D1 to D28 and D90 8.Changes in the proportion of blood fibrocytes from D1 to D16, D28 and D90 9.Proportion of patients with at least one episode of any healthcare-associated infection between inclusion and D28 ;Timepoint(s) of evaluation of this end point: at the end of the trial

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Countries

France

Contacts

Public ContactDRCI Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

fadila.amerali@aphp.fr0144841717

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026