Status:
COMPLETED
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Lead Sponsor:
Acorda Therapeutics
Conditions:
Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Left ventricular ejection fraction (LVEF) between 10% and 40%.
- Male or female, aged 18 to 75 years, inclusive.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01258387
Start Date
December 1 2010
End Date
March 1 2013
Last Update
July 1 2014
Active Locations (2)
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1
The Medical Group of Saint Joseph's
Atlanta, Georgia, United States, 30342
2
Vanderbilt University
Nashville, Tennessee, United States, 37232-8802