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

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ClinicalTrials.gov Identifier: NCT01258387
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

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

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Glial growth factor 2/ Neuregulin 1β3 Other: Placebo Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258387


Locations
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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
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Study Director: Anthony Caggiano, MD, PhD Acorda Therapeutics
More Information
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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01258387    
Other Study ID Numbers: 1101.1
First Posted: December 13, 2010    Key Record Dates
Results First Posted: July 1, 2014
Last Update Posted: July 1, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
 Cardiovascular Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action