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RECRUITING Phase 2

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

NCT04419649 · View on ClinicalTrials.gov ↗

Study Summary

The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.

Interventions

  • DRUG Elritercept

Study Locations (20)

Victoria

  • Boxhill Hospital — Box Hill
  • University Hospital Geelong — Geelong
  • Austin Health — Heidelberg
  • Royal Melbourne Hospital — Melbourne
  • St Vincent's Hospital Melbourne — Melbourne
  • Ballarat Oncology & Haematology Service — Wendouree

New South Wales

  • Border Medical Oncology Research — Albury
  • Tweed Hospital — Tweed Heads
  • Westmead Hospital — Westmead

Other

  • Fakultni nemocnice Brno — Brno
  • Fakultni nemocnice Kralovske Vinohrady — Prague
  • Vseobecna Fakultni Nemocnice Praha — Prague

Florida

  • University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC) — Miami
  • H. Lee Moffitt Cancer Center and Research Center — Tampa

South Australia

  • Royal Adelaide Hospital — Adelaide
  • Flinders Medical Centre — Bedford Park

California

  • City of Hope National Medical Center — Duarte

Michigan

  • Karmanos Cancer Institute at Mclaren Greater Lansing — Lansing

Pennsylvania

  • University of Pittsburgh Medical Health Center — Pittsburgh

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2020-08-19
Est. Completion 2031-10-30
Phase Phase 2

Sponsor

Takeda

387 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04419649

The ClinicalTrials.gov registry entry for NCT04419649 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention — of which Elritercept is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04419649 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Victoria, New South Wales, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04419649 about?

NCT04419649 is a clinical study titled "A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)". The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the s...

What is the current status of trial NCT04419649?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2020-08-19. Estimated completion is 2031-10-30.

What conditions does trial NCT04419649 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes, Cytopenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04419649?

The interventions under investigation include: Elritercept (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04419649?

This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04419649 being conducted?

This trial has 20 study locations across California, Florida, Michigan, Pennsylvania, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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