Clinical Trials in Turkey / 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 Turkey tracker
Condition(s) studied
Primary Immune Thrombocytopenia
Investigational drug(s) / intervention(s)
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
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)
- Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs) — 216 weeks
- Vital sign measurement: blood pressure in the overall population — 216 weeks
- ECG: PR, QT and QRS interval in the overall population — 216 weeks
- Laboratory safety evaluations: CRP analysis in the overall population — 216 weeks
Trial sites (83)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More argenx trials in Turkey
Other trials for the same condition
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 Turkey