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A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

NCT04687072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2024-10-31

Study results available
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Summary

This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.

Conditions

  • Primary Immune Thrombocytopenia

Interventions

BIOLOGICAL

Efgartigimod PH20 SC

Subcutaneous injection with efgartigimod PH20 SC

OTHER

Placebo PH20 SC

Subcutaneous injection with placebo PH20 SC

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2023-10-09
Completion
2023-10-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Chile
  • China
  • Denmark
  • France
  • Georgia
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Mexico
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Tunisia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Companies

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 NCT04687072 on ClinicalTrials.gov