A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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|ClinicalTrials.gov Identifier: NCT02538536|
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis (IPF)||Drug: PBI4050||Phase 2|
This Phase 2 multi-centre study will be performed by 6 Canadian sites. It is an open-label, single-arm study in patients with Idiopathic Pulmonary Fibrosis (IPF) aged 40 years and older.
The duration of study participation is approximately 20 weeks for each patient and comprises 6 study visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-label, Single Arm, Exploratory, Observational Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Four 200 mg capsules (total 800 mg) administered orally, once daily.
- Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: 4 months ]
- Change from baseline on pulmonary function tests [ Time Frame: 3 months ]
- Change from baseline in imaging of thorax [ Time Frame: 3 months ]
- Change from baseline on biomarkers [ Time Frame: 3 months ]
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): NCT02538536
|Canada, British Columbia|
|Vancouver, British Columbia, Canada|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada|
|Toronto, Ontario, Canada|
|Montreal, Quebec, Canada|
|Sherbrooke, Quebec, Canada|