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Clinical Trials in China / NCT04812925
Active, not recruiting Phase 3

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

NCT04812925 · tracked via the Priya Life Science China tracker
Sponsor
argenx
Phase
Phase 3
Started
2021-11-17
Last updated
2026-01-12

Condition(s) studied

Primary Immune Thrombocytopenia

Investigational drug(s) / intervention(s)

efgartigimod PH20 SC

efgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC

Study summary

A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits). 2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period. Note: If a participant has had an SAE during the ARGX-113-2004 trial, their eligibility should be evaluated by the investigator and the sponsor's trial physician. The decision of enrolling the participant will be evaluated case by case. 3a. Agree to use contraceptives consistent with local regulations and the following: • Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP. In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP), the following criteria apply: 4\. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits). 5\. Participant has completed a 52-week treatment period. Exclusion criteria: 1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines) 2. Use of any other investigational drug or participation in any other investigational trial 3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients 4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC

Primary outcome measure(s)

Trial sites (83)

FacilityCityRegionStatus
Investigator Site 0010116 Bentonville Arkansas
Investigator site 0010045 Washington D.C. District of Columbia
Investigator Site 0010062 Fort Wayne Indiana
Investigator site US0010042 Iowa City Iowa
Investigator Site 0010095 Oklahoma City Oklahoma
Investigator Site 0540001 Buenos Aires Argentina
Investigator site 540004 Buenos Aires Argentina
Investigator Site 0610012 Garran Australia
Investigator Site 0610003 West Perth Australia
Investigator site 610005 Westmead Australia
Investigator Site 3590017 Plovdiv Bulgaria
Investigator site 0560003 Reñaca Chile
Investigator site 560002 Santiago Chile
Investigator site 0560004 Temuco Chile
Investigator site 860013 Beijing China
Investigator Site 0860008 Bengbu China
Investigator site 860055 Huizhou China
Investigator Site 0860015 Shenzhen China
Investigator Site 0860001 Tianjin China
Investigator Site 0860010 Wuhan China
Investigator Site 0860002 Wuxi China
Investigator Site 0860011 Zhengzhou China
Investigator site 860058 Zhenjiang China
Investigator Site 9950007 Tbilisi Georgia
Investigator site 9950009 Tbilisi Georgia
Investigator site 9950011 Tbilisi Georgia
Investigator site 300008 Athens Greece
Investigator Site 0300009 Thessaloniki Greece
Investigator site 3530003 Dublin Ireland
Investigator site 390043 Ferrara Italy
Investigator Site 0390032 Milan Italy
Investigator Site 0390044 Naples Italy
Investigator site 390041 Naples Italy
Investigator site JP0810015 Hirakata Japan
Investigator Site 0810017 Iruma Japan
Investigator Site 0810053 Kanagawa Japan
Investigator Site 0810051 Kitakyushu Japan
Investigator site 0810016 Shibukawa Japan
Investigator site 810023 Shimotsuke Japan
Investigator Site 0810038 Tama Japan

+ 43 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04812925 on ClinicalTrials.gov ↗ ← All trials in China