drugset
drugset / Trial / NCT04593784

Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults

NCT04593784 ↗

Phase 2 Terminated 41 enrolled AMAG Pharmaceuticals, Inc. Ciraparantag Holdings GmbH · collab
RandomizedSequentialTriple-blindTreatment

Summary

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs in generally healthy adults as measured primarily by an automated coagulometer device.

Timeline

Start
2021-10-13
Primary completion
2023-08-26
Completion
2023-08-26

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision unrelated to safety”

registry analysis (other test); Cohort 1 (Edox) Cira 180 mg vs Cohort 1 (Edox) PBO; p = 0.248; Risk Difference (RD) -16.7; Baschloo Test NCT04593784 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciraparantag Small molecule 180 mg Intravenous

Indications

No indication recorded.