Phase 2
Completed N=18
A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation
Source: ClinicalTrials.gov NCT04213807 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Number of Participants That Achieved More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After the Third Dose (Day 91) at Different Dose Levels of MAA868 — 0; 2; 4; 0 Participants
Summary
This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or peripheral embolism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Achieved More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After the Third Dose (Day 91) at Different Dose Levels of MAA868 |
0; 2; 4; 0; 0; 1 | — |
| SECONDARY Number of Participants Achieving More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After First (Day 31) and Second Doses (Day 61) at Different Dose Levels of MAA868 |
0; 1; 5; 0; 2; 5 | — |
| SECONDARY Overall Number of Participants Who Experienced Adverse Events, Including Serious Adverse Events, During the Treatment Period and Through End of Study |
4; 5; 3 | — |
| SECONDARY Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Immunogenicity of MAA868 |
6; 7; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients ≥ 18 and 65 = 1 point, > 75 = 2 points), Diabetes, previous Stroke/transient ischemic attack (2 points) (CHA2DS2-VASc) risk score (tool as a predictor for estimating the risk of stroke in patients with atrial fibrillation (AF); Lip et al 2010) of 0-1 for men and 1-2 for women and in whom, in the investigator's judgment, the use of an anticoagulant for stroke prevention is not indicated
Exclusion Criteria
- History of stroke, transient ischemic attack or systemic embolism
- History of major bleeding during treatment with an anticoagulant or antiplatelet therapy. (Patients who have had major bleeding on anticoagulants or antiplatelet therapy more than a year ago can be enrolled only if the bleeding was due to a reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.)
- History of traumatic or non-traumatic intracranial, intraspinal or intraocular bleeding
- Known bleeding diathesis or any known active bleeding site at screening or baseline
- Family history of bleeding disorder
- Known active GI lesions predisposing to bleeding events
- Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the Screening period
- Known clinically significant valvular heart disease including moderate or severe mitral stenosis (valve area <1.5 cm2)
- Patients with a prosthetic heart valve
Other protocol defined Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT04213807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.