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

NCT06471088 | Recruiting FDA Drug

• 1 other identifier: PRET-TBZ-7a-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dovprela

Keywords

Pretomanid; tuberculosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  AE refers to undesirable and unintended signs (e.g., abnormalities in laboratory examination values), symptoms, or diseases that occur during the administration or use of drugs, etc., and it does not necessarily mean that it will have a causal relationship with the corresponding drug.

  Baseline up to approximately 6 months

Study Arms (1)

All Participants

This study will be conducted on subjects who were administered with Dovprela Tablets as part of their usual treatment in accordance with their local labelling. Clinical data obtained through observation will be collected from the time of the first dose of Dovprela tablet to 26 weeks of treatment and up to 6 months after the end of treatment.

Drug: Dovprela

Interventions

Dovprela DRUG

Daily dose: 200 mg

All Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients falling under any of the following criteria are not included in the study:
• Cases with duplicated studies (In the event of duplicated cases, the case that has been collected first will be recognized.)
• 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
• Patients with contraindications to use Bedaquiline and/or Linezolid as Dovprela Tablets are used as a combination treatment with Bedaquiline and Linezolid
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• 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.

Sponsors & Collaborators

• Viatris Inc.: lead

Study Sites (1)

Viatris

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: July 23, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)