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Immune Globulin · GamaSTAN

Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)

Ensayo de Grifols SA en Niveles de anticuerpos anti-hepatitis A en sujetos sanos.

Fase

Fase 4

Estado

Completado

Participantes

28

previstos

Centros

1

Fin del objetivo primario

abr 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2017.

Qué mide

Porcentaje de sujetos que mantienen niveles protectores de anticuerpos anti-HAV (dia 60)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled. There was a screening period of up to 28 days during which subjects were screened for enrollment in the study. Healthy subjects received a single intramuscular (IM) dose of GamaSTAN (0.2 mL/kg), followed by a pharmacokinetic (PK) sampling period of 150 days (approximately 5 half-lives). The protective levels of anti-HAV antibodies were assessed up to 60 days after the administration of GamaSTAN. A PK curve was obtained during the PK sampling period.

Más ensayos de GRFS

Todos los de GRFS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03351933), actualizada en jul 2019.