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A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02538536
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
ProMetic BioSciences Inc.

Brief Summary:
This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis (IPF) Drug: PBI4050 Phase 2

Detailed Description:

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)
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)
Study Start Date : July 2015
Primary Completion Date : January 2017
Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: PBI4050
Four 200 mg capsules (total 800 mg) administered orally, once daily.
Drug: PBI4050

Primary Outcome Measures :
  1. Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Change from baseline on pulmonary function tests [ Time Frame: 3 months ]
  2. Change from baseline in imaging of thorax [ Time Frame: 3 months ]
  3. Change from baseline on biomarkers [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is an adult aged 40 years or older
  2. Patient has signed written informed consent.
  3. Patient has been diagnosed of IPF according to the most recent guideline on IPF diagnosis and management released by American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT).
  4. Female patients of childbearing potential must have a negative urine pregnancy test and agree to use adequate birth control from screening throughout the study and for 30 days after the last study drug administration.
  5. If a male patient has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last study drug administration.

Exclusion Criteria:

  1. Patient has a known diagnosis of a respiratory disorder other than IPF.
  2. Substantial emphysema on high resolution computer tomography (HRCT) with degree of emphysema greater than fibrosis.
  3. Patient is an active smoker.
  4. Patient has evidence of active infection.
  5. Patients currently has or has a history of cancer, except basal cell carcinoma or squamous cell carcinoma of the skin.
  6. Patient has a concurrent medical or psychological condition that, in the investigator's opinion, may compromise the patient's ability to participate in the study or give informed consent, or may complicate the evaluations of the study drug.
  7. Patient is receiving another investigational treatment for IPF at screening and/or plans to receive an investigational treatment for IPF during the current study.
  8. Patient has chronic hepatitis or significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper limit of normal (ULN) or total bilirubin above ULN.
  9. Female patient who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.
  10. Woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study.
  11. Patient has participated in an investigational clinical trial during the last 4 weeks.

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 identifier (NCT number): NCT02538536

Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
ProMetic BioSciences Inc.

Responsible Party: ProMetic BioSciences Inc. Identifier: NCT02538536     History of Changes
Other Study ID Numbers: PBI-4050-ATX-9-03
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: October 2016

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial