Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Pirfenidone

• Registration Number: NCT02699879
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-16
• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-04
• Primary Completion: 2016-09-15
• Study Completion: 2016-09-15
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1009

Inclusion Criteria

• A clinical decision has been made, prior to study enrolment, to prescribe Esbriet
• Participants who are newly prescribed Esbriet therapy
• Initiation of Esbriet therapy is not more than 30 days prior to study enrolment

Exclusion Criteria

• Participants receiving an investigational agent defined as any drug that has not been approved for marketing for any indication in the country of the participating site
• Participant has received Esbriet therapy 30 days or more prior to current treatment course (e.g., prior participation in clinical trials)
• Participant has any contraindication for the use of Esbriet, according to the current local version of the Summary of Product Characteristics (SPC)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pirfenidone	Pirfenidone	Participants will receive pirfenidone orally according to the physician discretion.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with clinically significant ADRs of special interest	up to 2 years
Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions	up to 2 years

Trial Locations

Locations (106)

Medical University Graz; Department for Respiratory Diseases; 🇦🇹 Graz, Austria

LKH Hohenems; Abteilung für Pulmologie; 🇦🇹 Hohenems, Austria

Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre; 🇦🇹 Innsbruck, Austria

Klinikum Klagenfurt; Abteilung für Pulmologie; 🇦🇹 Klagenfurt, Austria

St. Johanns-Spital; Abt. Für Lungenkrankungen; 🇦🇹 Salzburg, Austria

Aarhus University Hospital; Lungemed afd. B; 🇩🇰 Aarhus, Denmark

Gentofte Hospital, Lungemedicinsk Afdeling; 🇩🇰 Hellerup, Denmark

Odense Universitetshospital, Lungemedicinsk Afdeling J; 🇩🇰 Odense, Denmark

Helsinki University Central Hospital; Dep. of Pulmonary Medicine; 🇫🇮 Helsinki, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

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