Quality of Life Study in Participants With IPF Under Pirfenidone Treatment

NCT ID: NCT03115619

Last Updated: 2020-08-21

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

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-18

Study Completion Date

2020-01-10

Brief Summary

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This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet).

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

PROSPECTIVE

Study Groups

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Participants With IPF

Observational data of participants with IPF under treatment with pirfenidone will be collected from the medical records as a part of their routine clinical visits at 12-week interval until study completion or early withdrawal (up to Week 52).

Pirfenidone

Intervention Type DRUG

Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC).

Interventions

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Pirfenidone

Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC).

Intervention Type DRUG

Other Intervention Names

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Esbriet

Eligibility Criteria

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Inclusion Criteria

* Adult participants for whom pirfenidone has already been prescribed for IPF no more than 4 weeks prior to enrollment, according to their physicians' clinical decision and the terms in the SmPC

Exclusion Criteria

* Participants who are participating in an interventional study or have received any investigational agent in the past 4 weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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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Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology

Athens, , Greece

Site Status

University General Hospital of Athens "Attikon", B' University Pulmonary Clinic

Chaïdári, , Greece

Site Status

University General Hospital of Heraklio, Pulmonary Clinic

Heraklio, , Greece

Site Status

University General Hospital of Ioannina

Ioannina, , Greece

Site Status

General University Hospital of Larisa; Pneumonology Clinic

Larissa, , Greece

Site Status

General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.

Thessaloniki, , Greece

Site Status

Papanikolaou Hospital; Pneumonology Clinic

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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ML39259

Identifier Type: -

Identifier Source: org_study_id

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