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
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|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Glial growth factor 2/ Neuregulin 1β3 Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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.
- 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
- 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
- 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
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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|
- Left ventricular ejection fraction (LVEF) between 10% and 40%.
- Male or female, aged 18 to 75 years, inclusive.
- 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.
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
|United States, Georgia|
|The Medical Group of Saint Joseph's|
|Atlanta, Georgia, United States, 30342|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232-8802|
|Study Director:||Anthony Caggiano, MD, PhD||Acorda Therapeutics|
|Responsible Party:||Acorda Therapeutics|
|Other Study ID Numbers:||
|First Posted:||December 13, 2010 Key Record Dates|
|Results First Posted:||July 1, 2014|
|Last Update Posted:||July 1, 2014|
|Last Verified:||June 2014|
Ventricular Dysfunction, Left
Molecular Mechanisms of Pharmacological Action