MedTrace Logo

Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy

NCT02154269 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-08-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease.

Conditions

  • Chronic Chagasic Myocarditis

Interventions

DRUG

Treatment with G-CSF (Granulocyte colony stimulating factor)

Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.

DRUG

Placebo saline

Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.

Sponsors & Collaborators

  • Hospital Sao Rafael

    lead OTHER

Principal Investigators

  • Milena BP Soares, PhD · Hospital São Rafael

  • Ticiana F Larocca, MD, Msc · Hospital São Rafael

  • Ricardo Ribeiro-dos-Santos, PhD · Hospital São Rafael

  • Bruno SF Souza, MD, Msc · Hospital São Rafael

  • Márcia MN Rabelo, MD, Msc · Hospital São Rafael

  • Luís Cláudio L Correia, MD, Msc · Hospital São Rafael

  • Carolina T Macedo, MD, Msc · Hospital São Rafael

  • Clarissa LM Souza, MD · Hospital São Rafael

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-10-31
Completion
2020-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02154269 on ClinicalTrials.gov