NCT03594045

Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT)

A Phase II Study to Evaluate the Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a drug as a possible treatment for heparin induced thrombocytopenia (HIT) or Heparin-induced Thrombocytopenia and Thrombosis (HITT). The drug involved in this study is apixaban.

Detailed description

This research study is a Phase II clinical trial. The FDA (the U.S. Food and Drug Administration) has not approved apixaban as a treatment option for this specific disease but it has been approved for other uses. HIT and HITT are common and severe complications of heparin therapy. Once patients are diagnosed with either one of these, they are typically switched to a non-heparin anticoagulant (a type of drug that thins your blood). As of now the only drug that is FDA approved for HIT or HITT is argatroban, which is administered continuously through an IV over multiple days and is extremely costly. In this research study, the investigators are researching the activity and tolerability of apixaban in participants with HIT or HITT. The investigators believe that apixaban will work just as well as argatroban and will be more convenient for this population. The oral route of apixaban allows for the potential outpatient treatment of HIT or HITT which is both convenient and less expensive than treatment with argatroban.

Conditions

• Heparin-induced Thrombocytopenia
• Heparin-induced Thrombocytopenia and Thrombosis

Interventions

Type	Name	Description
DRUG	Apixaban	Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.

Timeline

• Start date: 2018-12-18
• Primary completion: 2019-10-30
• Completion: 2019-10-30
• First posted: 2018-07-20
• Last updated: 2020-12-23
• Results posted: 2020-12-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study