Study Evaluating the Efficacy and Safety of Artesunate
A legfontosabb adatok
- Hol
- Boston és Rochester (Egyesült Államok)Mind a 2 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Massachusetts General HospitalBoston, Egyesült ÁllamokContact: Jaqueline Ferreira, BSRésztvevőt keres
- Mayo ClinicRochester, Egyesült ÁllamokContact: Adam MillerRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Amivas Inc.
- Azonosító
- NCT06853184
- A regiszteradat frissítve
- 2026. augusztus 3.
- Eredeti leírás
This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy and SOC treatment in SOT recipients with clinically significant CMV infection.A teljes eredeti leírásKevesebb
Phase 2, Randomized, Open-label, Active Comparator, Dose-ranging Study Evaluating the Efficacy and Safety of Artesunate for Injection in Combination With Ganciclovir or Valganciclovir for the Treatment of Cytomegalovirus Infection in Solid Organ Transplant Recipients
This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy and SOC treatment in SOT recipients with clinically significant CMV infection.
Bevonási feltételek: Be at least 18 years of age; Recipient of a solid organ transplant (kidney, lung, heart, or liver); Have a documented CMV infection; Have CMV DNAemia; Require IV GCV or oral VGCV; Be washed out from any anti-CMV antiviral drugs; Have all the following results as part of screening laboratory assessments; Have life expectancy of ≥ 12 weeks; Be willing and have an understanding and ability to fully comply with the study; If female use birth control.
Kizáró feltételek: Have CMV antiviral drug resistance; Require ongoing treatment with or an anticipated need for treatment with drugs with known interactions with artesunate or GCV; Taking any another investigational drug with anti-CMV activity; Have refractory CMV infection or disease; Have a known hypersensitivity to artesunate, GCV, or VGCV; Have severe liver disease; Have taken IV GCV or oral VGC daily for >8 days; Pregnant (or expecting to conceive) or nursing.