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A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP

NCT03102593 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-07-25

No results posted yet for this study

Summary

The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia.

Conditions

  • Primary Immune Thrombocytopenia

Interventions

DRUG

ARGX-113

ARGX-113 (Dose A or Dose B) or matching placebo will be administered IV weekly

OTHER

Placebo

ARGX-113 (Dose A or Dose B) or matching placebo will be administered IV weekly

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • argenx

    lead INDUSTRY

Principal Investigators

  • Adrian Newland · Barts Hospital, Cancer Centre in London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2019-04-09
Completion
2019-04-09

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

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 NCT03102593 on ClinicalTrials.gov