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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ProMetic BioSciences Inc.
ClinicalTrials.gov Identifier:
NCT02538536
First received: August 25, 2015
Last updated: April 10, 2017
Last verified: October 2016
  Purpose
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 Intervention Phase
Idiopathic Pulmonary Fibrosis (IPF) Drug: PBI4050 Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by ProMetic BioSciences Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 41
Study Start Date: July 2015
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PBI4050
Four 200 mg capsules (total 800 mg) administered orally, once daily.
Drug: PBI4050

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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02538536

Locations
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.
  More Information

Responsible Party: ProMetic BioSciences Inc.
ClinicalTrials.gov Identifier: NCT02538536     History of Changes
Other Study ID Numbers: PBI-4050-ATX-9-03
Study First Received: August 25, 2015
Last Updated: April 10, 2017

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

ClinicalTrials.gov processed this record on June 26, 2017