A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|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)|
- 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 ]
|Study Start Date:||July 2015|
|Study Completion Date:||January 2017|
|Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Four 200 mg capsules (total 800 mg) administered orally, once daily.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02538536
|Canada, British Columbia|
|Vancouver, British Columbia, Canada|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada|
|Toronto, Ontario, Canada|
|Montreal, Quebec, Canada|
|Sherbrooke, Quebec, Canada|