Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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|ClinicalTrials.gov Identifier: NCT02598193|
Recruitment Status : Completed
First Posted : November 5, 2015
Results First Posted : June 13, 2018
Last Update Posted : June 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Nintedanib Drug: Pirfenidone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary Fibrosis|
|Actual Study Start Date :||January 14, 2016|
|Actual Primary Completion Date :||May 16, 2017|
|Actual Study Completion Date :||May 16, 2017|
Participants with IPF will receive pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Participants with IPF will receive nintedanib at the 200-300 mg/day dose up to 24 weeks.
Other Name: Ofev
Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks.
Other Name: Esbriet
- Percentage of Participants Who Complete 24 Weeks of Combination Treatment on Pirfenidone at a Dose of 1602-2403 mg/Day and Nintedanib at a Dose of 200-300 mg/Day [ Time Frame: Week 24 ]
- Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Baseline up to Week 28 ]An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
- Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit [ Time Frame: Baseline up to Week 24 ]
- Total Number of Participant Days of Combination Treatment With Pirfenidone and Nintedanib [ Time Frame: Baseline up to Week 24 ]
- Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study Treatments [ Time Frame: Baseline up to Week 24 ]
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): NCT02598193
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|Study Director:||Clinical Trials||Hoffmann-La Roche|