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COMPLETEDPHASE1

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

NCT01258387•Acorda Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Left ventricular ejection fraction (LVEF) between 10% and 40%.
•2. Male or female, aged 18 to 75 years, inclusive.

Exclusion Criteria

•1. Received any investigational agent or participation in any clinical study of an investigational agent or investigational therapy up to 30 days prior to the screening visit.
•2. Use of any new prescription medication up to 14 days prior to receiving investigational drug.
•3. Patients with known specific hepatic disease; bilirubin \>2 mg/dL, SGOT \> 100 IU.
•4. Patients with a history of hepatic impairment (hepatitis B and C).
•5. Serum creatinine \>2.5 mg/dL.
•6. Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.

Locations (2)

The Medical Group of Saint Joseph's

Atlanta, Georgia, United States

Vanderbilt University

Nashville, Tennessee, United States

Key Dates

Start Date

December 1, 2010

Primary Completion Date

December 1, 2012

Completion Date

March 1, 2013

Last Updated

July 1, 2014

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

Glial growth factor 2/ Neuregulin 1β3

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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