DovprelaNCT06471088
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
An observational study of Dovprela, run by Viatris Inc. at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dovprela
- What is being tested?
- Dovprela
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jul 2023to 30 Jun 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: subjects who were administered with Dovprela Tablets as part of their usual treatment in accordance with their local labelling.
Who may be able to join
- To be eligible for participation in this study, subjects must meet the following inclusion criteria:
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Viatris
Seoul
Jin-Hye Cha, +82.10.7633.2494, Jin-Hye.Cha@Viatris.com
Jin-Sol Park, +82.10.8855.3977, Jin-Sol.Park@viatris.com
About this study
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
- Being tested
- Dovprela
- Keywords
- Pretomanid, tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DovprelaDrug
Daily dose: 200 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dovprela |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start23 Jul 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DovprelaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471088
- Sponsor's protocol ID
- PRET-TBZ-7a-001
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: All individuals directly concerned will comply with all relevant laws, including those in relation to the implementation of organizational and technical measures to ensure the protection of personal information of subjects. These actions include the deletion of the names of subjects or other directly identifiable data available in all reports, publications, or other disclosures, excluding events that are required by the corresponding law. Personal information is retained securely at the study institution in an encrypted electronic and/or written form and stored in a secure, password-protected or locked location to prevent access by unauthorized third parties.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
- ClinicalTrials.gov ID
- NCT06471088
- Acronym / sponsor ID
- PRET-TBZ-7a-001
- Conditions
- Dovprela
- Keywords
- Pretomanid, tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Drug: DovprelaThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjects who were administered with Dovprela Tablets as part of their usual treatment in accordance with their local labelling.
Key inclusion criteria (3 listed)
- To be eligible for participation in this study, subjects must meet the following inclusion criteria:
Key exclusion criteria (8 listed)
- Patients falling under any of the following criteria are not included in the study:
- Components: Lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DovprelaDaily dose: 200 mg | Drug | All Participants |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to approximately 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No. All individuals directly concerned will comply with all relevant laws, including those in relation to the implementation of organizational and technical measures to ensure the protection of personal information of subjects. These actions include the deletion of the names of subjects or other directly identifiable data available in all reports, publications, or other disclosures, excluding events that are required by the corresponding law. Personal information is retained securely at the study institution in an encrypted electronic and/or written form and stored in a secure, password-protected or locked location to prevent access by unauthorized third parties.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dovprela, run by Viatris Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Baseline up to approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.