Safety of HMA-CD20 in Patients With HFrEF

Summary

The study is a phase II single-centered, single group, prospective clinical trial to evaluate the safety of HMA-CD20 doses among stable patients with class III/IV according to the NYHA classification with HFrEF receiving standard of care therapy. The index qualifying HFrEF must have EF \< 40% based on echocardiographic or cardiac MRI techniques, heart failure class III/IV according to the NYHA classification,aged 40-60 years, being diagnosed less than 12 months before enrollment of study, following the standard heart failure treatment regimen.

Timeline

Start

2021-01-01

Primary completion

2021-04-16

Completion

2021-07-15

Publications

• Sanchez-Trujillo L, Jerjes-Sanchez C, Rodriguez D, Panneflek J, Ortiz-Ledesma C, Garcia-Rivas G, Torre-Amione G. Phase II clinical trial testing the safety of a humanised monoclonal antibody anti-CD20 in patients with heart failure with reduced ejection fraction, ICFEr-RITU2: study protocol. BMJ Open. 2019 Mar 27;9(3):e022826. doi: 10.1136/bmjopen-2018-022826.

Drugs

Indications