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

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ClinicalTrials.gov Identifier: NCT02699879
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Drug: Pirfenidone

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Study Type : Observational
Actual Enrollment : 1009 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting
Actual Study Start Date : February 16, 2012
Actual Primary Completion Date : September 15, 2016
Actual Study Completion Date : September 15, 2016


Group/Cohort Intervention/treatment
Pirfenidone
Participants will receive pirfenidone orally according to the physician discretion.
Drug: Pirfenidone
Pirfenidone will be administered according to the physician discretion as part of standard care.
Other Name: Esbriet




Primary Outcome Measures :
  1. Percentage of participants with clinically significant ADRs of special interest [ Time Frame: up to 2 years ]
  2. Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants receiving treatment for IPF with pirfenidone according to the physician's discretion
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699879


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02699879     History of Changes
Other Study ID Numbers: WB29908
PIPF-025 ( Other Identifier: InterMune )
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents