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RECRUITING
NCT06471088

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

Sponsor: Viatris Inc.

View on ClinicalTrials.gov

Summary

Dovprela 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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2023-07-23

Completion Date

2026-06-30

Last Updated

2024-06-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dovprela

Daily dose: 200 mg

Locations (1)

Viatris

Seoul, South Korea