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

Completed · Phase 1 · Has a placebo group

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT01258387

Run by

Acorda Therapeutics

People needed

40

Starts

2010-12-01

Expected to finish

2013-03-01

Last updated by the study team

2014-07-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Use of any new prescription medication up to 14 days prior to receiving investigational drug.
• Patients with known specific hepatic disease; bilirubin >2 mg/dL, SGOT > 100 IU.
• Patients with a history of hepatic impairment (hepatitis B and C).
• Serum creatinine >2.5 mg/dL.
• Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.

Where it is running

• The Medical Group of Saint Joseph's — Atlanta, Georgia, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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