Post Marketing Registry to Assess Usage, Safety and Effec... | NCT03470233

Studies
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB

NCT03470233

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Sep 17, 2021Actual

Enrollment

149Actual

Phase

Not provided

Conditions

Multi-drug Resistant Tuberculosis

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2017Actual

Primary Completion Date

Jun 21, 2021Actual

Completion Date

Jun 21, 2021Actual

First Submitted Date

Feb 6, 2018

First Submission Date that Met QC Criteria

Mar 12, 2018

First Posted Date

Mar 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2021

Last Update Posted Date

Sep 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

149Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose of Deltyba	Mean values	for 24 weeks
Administration duration of Deltyba	Mean values	for 24 weeks
Compliance of Deltyba	percentages (%) of subjects who take Deltyba in excess of 80% compared with the amount of Deltyba prescribed by investigators	for 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidences of AEs	Numbers (n) of subjects with AEs	at least 1 month after the final administration or premature discontinuation
Incidences of ADRs	Percentages (%) of subjects with ADRs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

1. Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included in the registry.

Exclusion Criteria

Patients with known hypersensitivity to Delamanid or any excipients of Deltyba®
Patients whose serum albumin < 2.8 g/dL
Patients taking medicinal products that are strong inducers of CYP3A (e.g. carbamazepine).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included.

The expected number of patients during the enrollment period is 248 patients based on the number of patients who might be taking Deltyba, which was estimated considering annual mean change rate from 2009 to 2014 and the rate of patients who had no resistance to pulmonary MDR-TB therapies2, 3.

Therefore, the target number of subjects is about 150, which is 60 % of the number of patients who are expected to take Deltyba during the registration period (n=248).

The number of subjects may vary from one investigator to another.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Ulsan University Hospital		Ulsan			South Korea
Pusan National University Yangsan Hospital

Type	Date	Date Unknown
Release	Jun 23, 2022
Reset	Apr 7, 2023

ID	Term
D014376	Tuberculosis
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections