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

Last updated: June 17, 2024
Sponsor: Viatris Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Dovprela

Clinical Study ID

NCT06471088
PRET-TBZ-7a-001
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • To be eligible for participation in this study, subjects must meet the followinginclusion criteria:

  1. Patients who have been administered Dovprela Tablets according to the currentlocal labelling after the study is initiated at the study institution

  2. Subjects who have consented to participate in this study by signing the dataprivacy statement

Exclusion

Exclusion Criteria:

  • Patients falling under any of the following criteria are not included in the study:

  1. Cases with duplicated studies (In the event of duplicated cases, the case thathas been collected first will be recognized.)

  2. Patients with hypersensitivity to active substance (Pretomanid) or components.The list of components is as follows: *Components: Lactose monohydrate, microcrystalline cellulose, povidone, sodiumstarch glycolate, magnesium stearate, colloidal silicon dioxide, sodium laurylsulfate

  3. Patients with contraindications to use Bedaquiline and/or Linezolid as DovprelaTablets are used as a combination treatment with Bedaquiline and Linezolid

  4. Patients with genetic problems such as galactose intolerance, Lapp lactasedeficiency or glucose-galactose malabsorption

  5. Other patients whom the investigator decides not to prescribe under generalpractice, considering the overall balance of risks and benefits, such as thosewho are pregnant or breastfeeding

If data of the subjects that have not been used within the scope of permitted items is collected, it shall be analysed as a separate item.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Dovprela
Phase:
Study Start date:
July 23, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Viatris

    Seoul,
    Korea, Republic of

    Active - Recruiting

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