Heart FailurePhase 1GGF2-1101-1NCT01258387
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
A Phase 1 study testing Glial growth factor 2/ Neuregulin 1β3 in people with Heart Failure, run by Acorda Therapeutics at 2 sites in United States.
Trial summary
Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Glial growth factor 2/ Neuregulin 1β3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to Mar 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left ventricular ejection fraction (LVEF) between 10% and 40%.
- Male or female, aged 18 to 75 years, inclusive.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Medical Group of Saint Joseph's
Atlanta, Georgia, 30342
Vanderbilt University
Nashville, Tennessee, 37232-8802
About this study
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 to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Glial growth factor 2/ Neuregulin 1β3, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glial growth factor 2/ Neuregulin 1β3Drug
Also called Recombinant Human Glial Growth Factor 2
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Glial growth factor 2/ Neuregulin 1β3; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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
Measured: Screening, day 8, day 14, day 28, and 3 months post-dose
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
Measured: Screening, day 8, day 14, day 28, and 3 months post-dose
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
Measured: Screening, day 8, day 14, day 28, and 3 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Caggiano, MD, PhD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258387
- Sponsor's protocol ID
- 1101.1
- Acronym
- GGF2-1101-1
- Status last verified
- Jun 2014
- First submitted
- 8 Dec 2010
- Last updated
- 1 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01258387
- Acronym / sponsor ID
- GGF2-1101-1 / 1101.1
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Dec 2010 (estimated)
- Results
- Posted 1 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GGF2 | Placebo comparator | Drug: Glial growth factor 2/ Neuregulin 1β3, Other: PlaceboSeven 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Left ventricular ejection fraction (LVEF) between 10% and 40%.
- Male or female, aged 18 to 75 years, inclusive.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glial growth factor 2/ Neuregulin 1β3Also: Recombinant Human Glial Growth Factor 2 | Drug | GGF2 |
| Placebo | Other | GGF2 |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Caggiano, MD, PhD study director
Acorda Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glial growth factor 2/ Neuregulin 1β3 in people with Heart Failure, run by Acorda Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.