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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01258387
First received: December 8, 2010
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Heart Failure
Drug: Glial growth factor 2 (neuregulin 1β3)
Drug: Glial growth factor 2/ Neuregulin 1β3
Drug: Glial Growth factor 2/ Neuregulin 1β3
Drug: Glial Growth Factor 2/ Neuregulin 1β3
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Double-Blind, Placebo-Controlled Study of Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • To evaluate the safety of single ascending doses of GGF2 via an assessment of the toxicology profile as measured by adverse events, changes in vital signs, ECG, liver function tests, laboratory clinical chemistries, and cardiodynamic measurements. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Safety/ tolerability of single dose; cumulative safety over 6 months


Enrollment: 40
Study Start Date: December 2010
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: GGF2 first dose
First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
Drug: Glial growth factor 2/ Neuregulin 1β3
Starting dose
Other Name: Recombinant Human Glial Growth Factor 2
Placebo Comparator: GGF2 second escalated dose
Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
Drug: Glial growth factor 2 (neuregulin 1β3)
Second dose
Other Name: Recombinant Human Glial Growth Factor 2
Placebo Comparator: GGF2 third escalated dose
Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
Drug: Glial growth factor 2/ Neuregulin 1β3
Third escalated dose
Other Name: Recombinant Human Glial Growth Factor 2
Placebo Comparator: GGF2 fourth escalated dose
Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
Drug: Glial Growth factor 2/ Neuregulin 1β3
Fourth escalated dose
Other Name: Recombinant Human Glial Growth Factor 2
Placebo Comparator: GGF2 fifth escalated dose
Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
Drug: Glial Growth Factor 2/ Neuregulin 1β3
Fifth escalated dose
Other Name: Recombinant Human Glial Growth Factor 2
Placebo Comparator: GGF2 sixth escalated dose
Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed .
Drug: Glial growth factor 2/ Neuregulin 1β3
Sixth escalated dose
Other Name: Recombinant Human Glial Growth Factor 2
Placebo Comparator: GGF2 seventh escalataed dose
Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
Drug: Glial growth factor 2/ Neuregulin 1β3
Seventh escalated dose
Other Name: Recombinant Human Glial Growth Factor 2

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258387

Locations
United States, Georgia
The Medical Group of Saint Joseph's
Atlanta, Georgia, United States, 30342
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-8802
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Anthony Caggiano, MD, PhD Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01258387     History of Changes
Other Study ID Numbers: 1101.1
Study First Received: December 8, 2010
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014