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A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

NCT04596995 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-02-05

Study results available
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Summary

The purpose of this study is to assess the long-term safety, tolerability and clinical efficacy of treatment with rozanolixizumab.

Conditions

  • Primary Immune Thrombocytopenia

Interventions

DRUG

Rozanolixizumab

Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Period.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2022-12-21
Completion
2022-12-21
FDA Drug
Yes

Countries

  • United States
  • China
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Japan
  • Moldova
  • Poland
  • Russia
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT04596995 on ClinicalTrials.gov