Trials / Unknown
UnknownNCT03332888
Safety of HMA-CD20 in Patients With HFrEF
Phase II Clinical Trial Testing the Safety of a Humanized Monoclonal Antibody Anti-CD20 in Patients With Heart Failure With Reduced Ejection Fraction
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud · Academic / Other
- Sex
- All
- Age
- 40 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab | Rituximab will be studied in patients with HFrEF, and verify the patients safety. |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2021-04-16
- Completion
- 2021-07-15
- First posted
- 2017-11-06
- Last updated
- 2020-08-05
Source: ClinicalTrials.gov record NCT03332888. Inclusion in this directory is not an endorsement.