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Cerebril™ in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy

CompletedPhase 2

Sponsor: Bellus Health Inc. - a GSK company

Conditions: Stroke, Neurologic Diseases, General

Interventions: NC-758 (Anti amyloidotic [Aß] agent)

Countries: United States

The main objective of this study is to evaluate the safety, tolerability and pharmacokinetics of Cerebril™ in Cerebral Amyloid Angiopathy (CAA) patients who have had lobar cerebral hemorrhage.

Eligibility overview

Sex: ALL

Age: 55 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

* Patients must be 55 years of age or older.
* Males and females. Females must be of non-childbearing potential (i.e. surgically sterilized or at least one year post-menopausal).
* Diagnosis of possible or probable CAA based on the Boston Criteria for Diagnosis of CAA-Related Hemorrhage.
* Nonfatal lobar hemorrhage (defined as hemorrhage in the cerebral cortex and underlying white matter sparing the basal ganglia and thalamus) within previous five years diagnosed by CT or MRI scan.
* Patient has no intent to donate blood for 4 weeks after completion of the study.
* Signed informed consent.

Exclusion Criteria

* Other established causes of hemorrhage at the time of the index hemorrhage event. Exclusion causes include excessive anticoagulation (INR \> 4.0), associated head trauma or ischemic stroke, CNS tumor, vascular malformation, vasculitis, and blood dyscrasia.
* Patient with a clinically significant and uncontrolled cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, hematological condition or other significant medical disease.
* Presence of any condition that could interfere with the interpretation of study results or compromise patient safety.
* Debilitated neurological state or other known disease likely to result in early death.
* Disability characterized by a modified Rankin score ≥ 4.
* ALT, ALP, AST or total bilirubin ≥ 1.5 the upper limit of normal ranges.
* Contraindications to MRI scan (e.g. cranial metallic implant, cardiac pacemaker, and severe claustrophobia).
* Allergy and/or hypersensitivity to analgesic agents used for the lumbar puncture (for patients undergoing lumbar puncture only).
* Allergy and/or hypersensitivity to any component of the study medication.
* Use of an investigational drug within 30 days prior to Screening visit.
* Use of warfarin or warfarin containing compounds and heparin or heparin containing compounds within 7 days prior to Baseline (Week 0) visit.
* Diagnosis of cystatin C amyloid angiopathy.
* Active alcohol and/or drug abuse.
* Inability to provide legal consent

Locations (5)

Lexington, Kentucky, United States
Boston, Massachusetts, United States
New York, New York, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States