Back to resultsSingle Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure (GGF2-1101-1)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glial growth factor 2/ Neuregulin 1β3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- The Medical Group of Saint Joseph's
- Vanderbilt University
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
GGF2
Arm 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
Outcomes
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)
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)
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)
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)
ESV is the volume of blood remaining in each ventricle at the end of systole.¹
¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01258387
Brief Title
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Acronym
GGF2-1101-1
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 Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GGF2
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Glial growth factor 2/ Neuregulin 1β3
Other Intervention Name(s)
Recombinant Human Glial Growth Factor 2
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)
Description
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
Time Frame
Screening, day 8, day 14, day 28, and 3 months post-dose
Title
Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)
Description
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
Time Frame
Screening, day 8, day 14, day 28, and 3 months post-dose
Title
Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)
Description
ESV is the volume of blood remaining in each ventricle at the end of systole.¹
¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume
Time Frame
Screening, day 8, day 14, day 28, and 3 months post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Caggiano, MD, PhD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
The Medical Group of Saint Joseph's
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8802
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
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