A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
A legfontosabb adatok
- Ki végzi
- argenx
- Hol
- Bentonville, Fort Wayne, Iowa City, Oklahoma City és Washington D.C. (Egyesült Államok)Mind a 5 helyszín megnézéseMég 24 másik országban, 73 helyszínen
- Állapot
- Fut, nem toboroz
- Fázis
- 3. fázis
- Résztvevők
- 173 fő vett részt
- Kezdés
- 2021. nov. 17.
- Várható befejezés
- 2027. okt.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- efgartigimod PH20 SC
- A regiszteradat frissítve
- 2026. október 19.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- 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)
- Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period
- Agree to use contraceptives consistent with local regulations
- In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period, the participant has completed a 52-week treatment period
Ki nem vehet részt
- 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)
- Use of any other investigational drug or participation in any other investigational trial
- Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients
- 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
Helyszínek itt: Egyesült Államok
Még 24 másik országban, 73 helyszínen
- Bentonville, ArkansasHospital not named in the registryNo longer taking part
- Fort Wayne, IndianaHospital not named in the registryNo longer taking part
- Iowa City, IowaHospital not named in the registryNo longer taking part
- Oklahoma City, OklahomaHospital not named in the registryNo longer taking part
- Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
The main aim of the study is to evaluate the safety and efficacy of efgartigimod PH20 SC (subcutaneous) in adult patients with primary immune thrombocytopenia (ITP). Participants who completed the 24-week trial period of the ARGX- 113-2004 trial are given the opportunity to enter into this open-label extension trial and receive efgartigimod PH20 SC.
A teljes eredeti leírásKevesebb
Participants will be offered the opportunity to continue in this trial if they have completed the first 52-week treatment period unless efgartigimod becomes commercially available for patients with primary ITP or becomes available through another program for patients with primary ITP, whichever comes first. A maximum of three additional 52-week treatment periods will be offered to the participant to continue this trial.
The total trial duration per participant is up to 4 years (52-week treatment period, extendable with three additional 52-week treatment periods) + 8 weeks follow-up period.
A vizsgálat csoportja
- efgartigimod PH20 SCA vizsgált kezelés
Patients receiving efgartigimod PH20 SC treatment
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
- Hivatalos cím
- A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
- A regiszteradat frissítve
- 2026. október 19.