Phase 1 N=40 Randomized Double-blind Treatment

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

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT01258387 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Jul 2014

Primary outcome: Primary: Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) — 6; 4; 4; 2 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Glial growth factor 2/ Neuregulin 1β3 (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Acorda Therapeutics
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)	6; 4; 4; 2; 4; 4	—
SECONDARY Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)	-0.82; 4.75; 5.00; 2.50; 4.25; -1.25	—
SECONDARY Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)	-14.89; 27.50; 1.98; -10.60; -2.15; -35.00	—
SECONDARY Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)	-0.92; 12.38; -6.98; -15.95; -5.25; -26.50	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT01258387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.