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

NCT06471088 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-06-24

No results posted yet for this study

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

DRUG

Dovprela

Daily dose: 200 mg

Sponsors & Collaborators

  • Viatris Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-23
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06471088 on ClinicalTrials.gov