Open-Label Rollover Study of PBI 4050 in Subjects With Alström Syndrome

• Status: Terminated
• Trial end date: 2020-05-08
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2, open-label, single-arm, multi-centre study evaluating the long term safety and tolerability of PBI-4050 in subjects with Alström Syndrome who have completed a preceding ProMetic-sponsored Alström Syndrome study with PBI-4050.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liminal BioSciences Ltd.; ProMetic BioSciences Inc.

Criteria

Inclusion Criteria:

• Subject completed a preceding ProMetic-sponsored Alström syndrome study with PBI-4050.

• Subject has signed informed consent

• Subject has a documented diagnosis of Alström syndrome

• Subject receiving antidiabetic medications is able and willing to self-monitor blood glucose levels

• Subject must be willing to forego other forms of experimental drug treatment during the study.

• Female subjects of childbearing potential must have a negative serum pregnancy test at screening and agree to use adequate birth control from screening throughout the study and for 30 days after the last Investigational Medicinal Product (IMP) administration

• If a male subject 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 IMP administration.

Exclusion Criteria:

• Subject discontinued PBI-4050 for safety reasons from any preceding ProMetic-sponsored Alström syndrome study with PBI-4050

• Subject has had a documented episode of severe hypoglycaemia within 12 months before screening and investigator judges that the subject is unable to adequately monitor their glucose levels.

• Subject has uncontrolled hypertension with BP > 170/100 mmHg as determined at screening.

• Woman who is pregnant, breast-feeding, or planning a pregnancy during the course of the study as determined at screening

• Subject has any condition that, in the investigator's opinion, is likely to interfere with study conduct and compliance

• Subject has a history of an allergic reaction to PBI-4050 or any of its excipients.