Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03342404 · ClinicalTrials.gov registry record · Phase 2
A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 145
- Enrollment target
NCT03342404 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 145 participants.
The verdict
NCT03342404, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 145 participants
- Enrollment target
Study Summary
This is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in adults with non-transfusion dependent beta (β)-thalassemia. The study is divided into the Screening Period, Double-blind Treatment Period (DBTP), Open-label Phase (OLP), and Post-Treatment Follow-up Period (PTFP). It is planned to randomize approximately 150 subjects at a 2:1 ratio of luspatercept versus placebo.
Interventions
- OTHER Placebo
- DRUG Luspatercept
- OTHER Best Supportive Care (BSC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2022-11-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03342404
The ClinicalTrials.gov registry entry for NCT03342404 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03342404 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03342404 about?
NCT03342404 is a clinical study titled "A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia". This is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in adults with non-transfusion dependent beta (β)-thalassemia. The study is divided into the Screening Period, Double-blind Treatment Perio...
What is the current status of trial NCT03342404?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 145 participants. The study started on 2018-02-05. Estimated completion is 2022-11-28.
What interventions are being tested in trial NCT03342404?
The interventions under investigation include: Placebo (OTHER), Luspatercept (DRUG), Best Supportive Care (BSC) (OTHER).
Who is sponsoring clinical trial NCT03342404?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.