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

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258387
• Other study ID #: 1101.1
• Status: Completed
• Phase: Phase 1
• First received: December 8, 2010
• Last updated: June 30, 2014
• Start date: December 2010
• Est. completion date: March 2013

Study information

• Verified date: June 2014
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• Glial growth factor 2/ Neuregulin 1ß3

Other:
• Placebo

Locations

Country	Name	City	State
United States	The Medical Group of Saint Joseph's	Atlanta	Georgia
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	Yes
Secondary	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	Screening, day 8, day 14, day 28, and 3 months post-dose	Yes
Secondary	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	Screening, day 8, day 14, day 28, and 3 months post-dose	Yes
Secondary	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	Screening, day 8, day 14, day 28, and 3 months post-dose	Yes