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NCT01258387 · ClinicalTrials.gov registry record · Phase 1
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
A Phase 1 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01258387: Completed Phase 1 study, sponsored by Acorda Therapeutics.
NCT01258387 is a Phase 1 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01258387, a Phase 1 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.
Primary Outcome
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.
Interventions
- OTHER Placebo
- DRUG Glial growth factor 2/ Neuregulin 1β3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01258387 record still lists
NCT01258387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01258387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01258387 about?
NCT01258387 is a clinical study titled "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.
What is the current status of trial NCT01258387?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2010-12. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01258387?
The interventions under investigation include: Placebo (OTHER), Glial growth factor 2/ Neuregulin 1β3 (DRUG).
Who is sponsoring clinical trial NCT01258387?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01258387's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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