Clinical trial NCT06471088: Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
Official title: Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dovprela
Keywords: Pretomanid
tuberculosis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-24
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects who were administered with Dovprela Tablets as part of their usual treatment in accordance with their local labelling.

Brief 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 Criteria:

* To be eligible for participation in this study, subjects must meet the following inclusion criteria:

  1. Patients who have been administered Dovprela Tablets according to the current local labelling after the study is initiated at the study institution
  2. Subjects who have consented to participate in this study by signing the data privacy statement

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 that has 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, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate
  3. Patients with contraindications to use Bedaquiline and/or Linezolid as Dovprela Tablets are used as a combination treatment with Bedaquiline and Linezolid
  4. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  5. Other patients whom the investigator decides not to prescribe under general practice, considering the overall balance of risks and benefits, such as those who 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Viatris
Study officials:
References: