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NCT01899859 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
A Phase 1 study, sponsored by Galectin Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01899859: Completed Phase 1 study, sponsored by Galectin Therapeutics.
NCT01899859 is a Phase 1 study that has completed, run by Galectin Therapeutics. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01899859, a Phase 1 study, has completed, sponsored by Galectin Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis.
Primary Outcome
The primary objective of this study is to characterize the safety, which includes the tolerability and dose-limiting toxicity (DLT), for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis. Specifically, this measure will be assessed by number of subjects experiencing treatment emergent adverse events indicative of DLT.
Interventions
- DRUG Placebo
- DRUG GR-MD-02
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT01899859 record still lists
NCT01899859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01899859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01899859 about?
NCT01899859 is a clinical study titled "Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis". The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis.
What is the current status of trial NCT01899859?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2013-07. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01899859?
The interventions under investigation include: Placebo (DRUG), GR-MD-02 (DRUG).
Who is sponsoring clinical trial NCT01899859?
This trial is sponsored by Galectin Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01899859's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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