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NCT03866577 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
A Phase 1 study, sponsored by Momenta Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT03866577: Clinical Trial Phase 1 study, sponsored by Momenta Pharmaceuticals.
NCT03866577 is a Phase 1 study that was terminated before completion, run by Momenta Pharmaceuticals. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03866577, a Phase 1 study, was terminated before completion, sponsored by Momenta Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP.
Primary Outcome
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE was defined as any event not present prior to administration of the study drug or any event already present that worsened in either severity or frequency following exposure to the study drug. Severity was graded according to the National Cancer Institute Common Te
Interventions
- DRUG Placebo
- BIOLOGICAL Biological: M254
- BIOLOGICAL Intravenous immunoglobulin (IVIg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2021-06-09 |
| Phase | Phase 1 |
Why NCT03866577 stopped before completion
NCT03866577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03866577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03866577 about?
NCT03866577 is a clinical study titled "Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients". The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as ...
What is the current status of trial NCT03866577?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2018-12-21. Estimated completion is 2021-06-09.
What interventions are being tested in trial NCT03866577?
The interventions under investigation include: Placebo (DRUG), Biological: M254 (BIOLOGICAL), Intravenous immunoglobulin (IVIg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03866577?
This trial is sponsored by Momenta Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03866577's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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