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: June 30, 2014
Last verified: June 2014
  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
Other: Placebo
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:
  • Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Safety/ tolerability of single dose; cumulative safety over 6 months

    TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment.



Secondary Outcome Measures:
  • Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) [ Time Frame: Screening, day 8, day 14, day 28, and 3 months post-dose ] [ Designated as safety issue: Yes ]

    An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹

    Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.²

    ¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/

    ²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286


  • Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) [ Time Frame: Screening, day 8, day 14, day 28, and 3 months post-dose ] [ Designated as safety issue: Yes ]

    EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹

    ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume


  • Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) [ Time Frame: Screening, day 8, day 14, day 28, and 3 months post-dose ] [ Designated as safety issue: Yes ]

    ESV is the volume of blood remaining in each ventricle at the end of systole.¹

    ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume



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
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
Drug: Glial growth factor 2/ Neuregulin 1β3
Other Name: Recombinant Human Glial Growth Factor 2
Other: Placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: April 15, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014