Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure (GGF2-1101-1)

Acorda Therapeutics

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Drug: Glial growth factor 2/ Neuregulin 1β3; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01258387

1101.1

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 1 patient group, including a placebo group

GGF2

Placebo Comparator group

Description:

Seven dosing cohorts: 2 patients randomized to receive 1 GGF2, 1 placebo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed

Treatment:

Drug: Glial growth factor 2/ Neuregulin 1β3

Other: Placebo