Status:
COMPLETED
Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease
Lead Sponsor:
Qu Biologics Inc.
Conditions:
Crohn's Disease
Inflammatory Bowel Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's ...
Eligibility Criteria
Inclusion
- An adult, age 18 and above
- Diagnosed with Crohn's disease AT LEAST six (6) months prior to screening
- Crohn's disease diagnosis was verified by one of these procedures: 1) Colonoscopy 2) Capsule endoscopy 3) Computed Tomography (CT) scan 4) Magnetic Resonance Imaging (MRI) 5) Ultrasound
- Active Crohn's disease at the time of screening
- Female participants: Agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form, during the entire study treatment and for two (2) months after taking the last dose of study treatment.
- Male participants: Agree to practice effective barrier contraception during the entire study treatment period and for two (2) months after taking the last dose of study treatment.
Exclusion
- Currently pregnant or breastfeeding
- Have known or suspected hypersensitivity to any component of the product
- Had more than three (3) small bowel resections or diagnosis of short bowel syndrome
- Currently anticipate undergoing any major surgical intervention for Crohn's disease during the next six (6) months
- Previously been treated with any Qu Biologics' Site Specific Immunomodulators (SSIs) for any disease
- Diagnosed with chronic (i.e., long term) hepatitis B or C infection
- Diagnosed with congenital (i.e., existing at or before birth) or acquired immunodeficiency (i.e., lack of body defense system). For example, human immunodeficiency virus (HIV) infection, organ transplantation (i.e., specifically received an organ from a donor), etc.
- Daily use of narcotic drugs containing opiates (such as morphine, codeine, etc.) for pain control
- Have a current or recent history (within the past 12 months) of alcohol dependence or illicit drug use, with the exception of medicinal marijuana prescribed by a physician
- Have a history of cancer within the last five (5) years. Exceptions may apply for cervical cancer and some forms of skin cancer
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01809275
Start Date
March 1 2013
End Date
July 1 2016
Last Update
August 23 2016
Active Locations (4)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
2
University of Alberta Zeidler Ledcor Centre
Edmonton, Alberta, Canada, T6G 2X8
3
GI Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
4
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada, L4L 4Y7