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NCT03194542 · ClinicalTrials.gov registry record · Phase 2

A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence

A Phase 2 study, sponsored by Celgene.

Completed
Registry status
Phase 2
Development phase
95
Enrollment target

NCT03194542 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 95 participants.

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The verdict

NCT03194542, a Phase 2 study, has completed, sponsored by Celgene.

COMPLETED
Registry status
Phase 2
Development phase
95 participants
Enrollment target

Study Summary

This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.

Interventions

  • DRUG Luspatercept

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2017-11-15
Est. Completion 2022-07-18
Phase Phase 2

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT03194542

The ClinicalTrials.gov registry entry for NCT03194542 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 95 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 1 intervention - of which Luspatercept is the first listed.

NCT03194542 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03194542 about?

NCT03194542 is a clinical study titled "A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence". This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, ...

What is the current status of trial NCT03194542?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2017-11-15. Estimated completion is 2022-07-18.

What interventions are being tested in trial NCT03194542?

The interventions under investigation include: Luspatercept (DRUG).

Who is sponsoring clinical trial NCT03194542?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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