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The DART Study- Daratumumab Treatment in ITP

NCT04703621 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-04-09

No results posted yet for this study

Summary

A multicenter clinical, open-label total dose-escalating phase II study with safety run-in to explore the clinical activity, total dosage, and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after corticosteroids and at least one second-line therapy including rituximab and/or TPO-RA.

Conditions

Interventions

DRUG

Daratumumab Injection

subcutaneious daratumumab administration

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • Henri Mondor University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Waleed Ghanima, PhD · Ostfold Hospital Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2024-04-30
Completion
2024-12-31

Countries

  • Denmark
  • France
  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04703621 on ClinicalTrials.gov