- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00810407
Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
Special Investigation For Non-hiv Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered Mycobutin®.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
rifabutin
Patients administered Rifabutin.
|
Mycobutin® capsules150mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " 1.Tuberculosis : The usual adult dosage for oral use is 150 mg to 300 mg of rifabutin once daily.For the treatment of multiple-drug resistance tuberculosis, the usual dosage for oral use is 300 to 450 mg of rifabutin once daily. 2.Treatment of non-tuberculous mycobacterial diseases (including MAC disease) : The usual adult dosage for oral use is 300 mg of rifabutin once daily".
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Related Adverse Events
Time Frame: 1 year
|
A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin.
Relatedness to Mycobutin was assessed by the physician/investigator.
|
1 year
|
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Time Frame: 1 year
|
A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin.
Expectedness of the adverse event was determined according to the Japanese package insert.
Relatedness to Mycobutin was assessed by the physician/investigator.
|
1 year
|
Number of Participants With Treatment-Related Adverse Events by Diagnosis
Time Frame: 1 year
|
A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin.
Relatedness to Mycobutin was assessed by the physician/investigator.
Participants with treatment related adverse events were counted by diagnosis to assess whether they were risk factors for the treatment related adverse events.
|
1 year
|
Number of Participants With Treatment-Related Adverse Events by Gender
Time Frame: 1 year
|
A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin.
Relatedness to Mycobutin was assessed by the physician/investigator.
Participants with treatment related adverse events were counted by gender to assess whether they were risk factors for the treatment related adverse events.
|
1 year
|
Number of Participants With Treatment-Related Adverse Events by Age
Time Frame: 1 year
|
A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin.
Relatedness to Mycobutin was assessed by the physician/investigator.
Participants with treatment related adverse events were counted by age to assess whether they were risk factors for the treatment related adverse events.
|
1 year
|
Clinical Efficacy Rate
Time Frame: 1 year
|
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator.
Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values.
|
1 year
|
Clinical Efficacy Rate by Diagnosis
Time Frame: 1 year
|
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator.
Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values.
Participants achieved clinical effectiveness by diagnosis were counted to assess whether they contribute to the clinical effectiveness.
|
1 year
|
Clinical Efficacy Rate by Gender
Time Frame: 1 year
|
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented.
Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator.
Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values.
Participants achieved clinical effectiveness by gender were counted to assess whether they contribute to the clinical effectiveness.
|
1 year
|
Clinical Efficacy Rate by Age
Time Frame: 1 year
|
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented.
Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator.
Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values.
Participants achieved clinical effectiveness by age were counted to assess whether they contribute to the clinical effectiveness.
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A0061006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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