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

NCT01258387 | Completed Phase 1 Results DMC

• 1 other identifier: 1101.1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

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)

  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

Secondary Outcomes (3)

• Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)

  Screening, day 8, day 14, day 28, and 3 months post-dose

• Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)

  Screening, day 8, day 14, day 28, and 3 months post-dose

• Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)

  Screening, day 8, day 14, day 28, and 3 months post-dose

Study Arms (1)

GGF2

PLACEBO COMPARATOR

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: Placebo

Interventions

Glial growth factor 2/ Neuregulin 1β3 DRUG

Also known as: Recombinant Human Glial Growth Factor 2

GGF2

Placebo OTHER

GGF2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left ventricular ejection fraction (LVEF) between 10% and 40%.
• Male or female, aged 18 to 75 years, inclusive.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (2)

The Medical Group of Saint Joseph's

Atlanta, Georgia, 30342, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-8802, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Neuregulins

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Nerve Tissue Proteins; Biological Factors

Results Point of Contact

• Title: Anthony Caggiano, MD, PhD
• Organization: Acorda Therapeutics, Inc.

tcaggiano@acorda.com

914-347-4300

Study Officials

• Anthony Caggiano, MD, PhD

  Acorda Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 13, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 1, 2014
• Results First Posted: July 1, 2014

Record last verified: 2014-06

Locations

US (2)