NCT01258387

Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure

A Phase 1, Double-Blind, Placebo-Controlled Study of Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.

Detailed description

Phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Glial growth factor 2/ Neuregulin 1β3
OTHER	Placebo

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2010-12-13
• Last updated: 2014-07-01
• Results posted: 2014-07-01

Locations

2 sites across 1 country: United States