Calendario›VTRS›Dovprela

Dovprela

Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance

Ensayo de Viatris Inc en Dovprela (del registro, en inglés).

Fase

no aplica

Estado

Sin noticias del promotor

Participantes

100

previstos

Centros

1

Fin del objetivo primario

jun 2026

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en jul 2023.

Qué mide

Number of Participants With Adverse Events (AEs) (Baseline up to approximately 6 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroDovprela Tablets (Pretomanid) is the only treatment approved for the treatment of drug-resistant tuberculosis on a wider scale. This non-interventional post-marketing surveillance (PMS) study is one of the obligations that must be followed under the Ministry of Food and Drug Safety (MFDS). In accordance with the Pharmaceutical Affairs Act and the re-examination criteria for new drugs, etc. notified by the MFDS, this study will be conducted with the purpose to collect and review required information on the safety and efficacy of drugs requiring re-examination for appropriate use. Safety and efficacy information will be provided for a minimum of 100 subjects who receive treatment in general clinical settings for a period of 4 years following approval. This survey is an open, non-comparative, non-interventional, prospective, multicenter study conducted by certified physicians (i.e., the investigator) at a Korean medical institution.

Más ensayos de VTRS

Todos los de VTRS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06471088), actualizada en jun 2024.