NCT06471088

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Viatris Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Dovprela

Interventions

Type	Name	Description
DRUG	Dovprela	Daily dose: 200 mg

Timeline

• Start date: 2023-07-23
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-06-24
• Last updated: 2024-06-24

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study