Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure (GGF2-1101-1)
This study has been completed.
Sponsor:
Acorda Therapeutics
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01258387
First received: December 8, 2010
Last updated: April 24, 2013
Last verified: April 2013
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Purpose
Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Drug: Glial growth factor 2 (neuregulin 1β3) Drug: Glial growth factor 2/ Neuregulin 1β3 Drug: Glial Growth factor 2/ Neuregulin 1β3 Drug: Glial Growth Factor 2/ Neuregulin 1β3 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Acorda Therapeutics:
Primary Outcome Measures:
- To evaluate the safety of single ascending doses of GGF2 via an assessment of the toxicology profile as measured by adverse events, changes in vital signs, ECG, liver function tests, laboratory clinical chemistries, and cardiodynamic measurements. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Safety/ tolerability of single dose; cumulative safety over 6 months
| Enrollment: | 40 |
| Study Start Date: | December 2010 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: GGF2 first dose
First dosing: 1 GGF2, 1 pbo; 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
Starting dose
Other Name: Recombinant Human Glial Growth Factor 2
|
|
Placebo Comparator: GGF2 second escalated dose
Second dosing: 1 GGF2, 1 pbo; 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)
Second dose
Other Name: Recombinant Human Glial Growth Factor 2
|
|
Placebo Comparator: GGF2 third escalated dose
Third dosing: 1 GGF2, 1 pbo; 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
Third escalated dose
Other Name: Recombinant Human Glial Growth Factor 2
|
|
Placebo Comparator: GGF2 fourth escalated dose
Fourth dosing: 1 GGF2, 1 pbo; 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
Fourth escalated dose
Other Name: Recombinant Human Glial Growth Factor 2
|
|
Placebo Comparator: GGF2 fifth escalated dose
Fifth dosing: 1 GGF2, 1 pbo; 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
Fifth escalated dose
Other Name: Recombinant Human Glial Growth Factor 2
|
|
Placebo Comparator: GGF2 sixth escalated dose
Sixth dosing: 1 GGF2, 1 pbo; 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
Sixth escalated dose
Other Name: Recombinant Human Glial Growth Factor 2
|
|
Placebo Comparator: GGF2 seventh escalataed dose
Seventh dosing: 1 GGF2, 1 pbo; 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
Seventh escalated dose
Other Name: Recombinant Human Glial Growth Factor 2
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258387
Locations
| 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
| Study Director: | Anthony Caggiano, MD, PhD | Acorda Therapeutics |
More Information
No publications provided
| Responsible Party: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01258387 History of Changes |
| Other Study ID Numbers: | 1101.1 |
| Study First Received: | December 8, 2010 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Heart Failure Ventricular Dysfunction, Left Ventricular Dysfunction Heart Diseases Cardiovascular Diseases |
Mitogens Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013