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Completed

NCT Number: NCT01258387

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Medical Group of Saint Joseph's, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glial growth factor 2/ Neuregulin 1β3

Drug

Other names: Recombinant Human Glial Growth Factor 2

Placebo

Other

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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

  2. 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

    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

  3. 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

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

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

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study 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

Acronym: GGF2-1101-1

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 13, 2010
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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