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Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)

NCT ID: NCT02622477

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants with idiopathic pulmonary fibrosis

Participants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses.

Pirfenidone

Intervention Type DRUG

This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.

Interventions

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Pirfenidone

This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet been treated with Pirfenidone

Exclusion Criteria

Hypersensitivity to the active substance or one of the other excipients of Pirfenidone Concomitant use of Fluvoxamin Severe hepatic impairment or end stage liver disease Severe renal impairment (Creatinine-Clearance \<30 ml/min) or end stage renal disease requiring dialysis Simultaneous participation in interventional studies Previously treated with Pirfenidone for longer than 30 days
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InterMune Deutschland GmbH

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Praxis Dr. med. Mathias Rolke und Dr. med. Peter Rückert

Aschaffenburg, , Germany

Site Status

Evang. Lungenklinik Berlin Klinik für Pneumologie

Berlin, , Germany

Site Status

Dr. med. Martin Hoster, Dr. Hans-G. Lange von Stocmeier, Michael Behn und w.

Bochum, , Germany

Site Status

Praxis Dr. med. Wilhelm Ammenwerth

Bochum, , Germany

Site Status

Augusta Kranken-Anstalt gGmbH

Bochum, , Germany

Site Status

Kliniken der Stadt Köln gGmbH Krankenhaus Merheim

Cologne, , Germany

Site Status

Fachkrankenhaus Coswig GmbH

Coswig, , Germany

Site Status

Klinikum Werra-Meißner GmbH

Eschwege, , Germany

Site Status

Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

Essen, , Germany

Site Status

Universitätsklinikum Freiburg, Abteilung Pneumologie

Freiburg im Breisgau, , Germany

Site Status

Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda

Fulda, , Germany

Site Status

Ev. Krankenhaus Göttingen-Weende E.V.

Göttingen, , Germany

Site Status

Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

Halle, , Germany

Site Status

Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie

Magdeburg, , Germany

Site Status

Thoraxzentrum, Abt. Pneumologie

Münnerstadt, , Germany

Site Status

Praxis Dr. med. Matthias Waltert

Münster, , Germany

Site Status

Facharztzentrum üBAG

Sonneberg, , Germany

Site Status

Countries

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Germany

References

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Schreiber J, Schutte W, Koerber W, Seese B, Koschel D, Neuland K, Grohe C. Clinical course of mild-to-moderate idiopathic pulmonary fibrosis during therapy with pirfenidone: Results of the non-interventional study AERplus. Pneumologie. 2024 Apr;78(4):236-243. doi: 10.1055/a-2267-2074. Epub 2024 Apr 12.

Reference Type DERIVED
PMID: 38608658 (View on PubMed)

Other Identifiers

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ML30016

Identifier Type: -

Identifier Source: org_study_id

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