- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00810446
Safety And Efficacy Of Rifabutin In HIV Patients
DRUG USE INVESTIGATION FOR HIV INFECTION PATIENTS OF MYCOBUTIN (REGULATORY POST MARKETING COMMITMENT PLAN).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
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
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. 3.Inhibition of disseminated Mycobacterium avium complex (MAC) disease associated with HIV infections : 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 Patients With Adverse Drug Reactions in This Surveillance
Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules.
A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly.
Relatedness to MYCOBUTIN Capsules was assessed by the physician.
|
6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)
Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules.
Relatedness to MYCOBUTIN Capsules was assessed by the physician.
Expectedness of the adverse drug reaction was determined according to the Japanese package insert.
|
6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
Number of Participants With Adverse Drug Reactions by Gender
Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules.
Relatedness to MYCOBUTIN Capsules was assessed by the physician.
Participants with ADRs were counted by gender to access whether it was a risk factor for the ADR.
|
6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
Number of Participants With Adverse Drug Reactions by Age
Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules.
Relatedness to MYCOBUTIN Capsules was assessed by the physician.
Participants with ADRs were counted by age to assess whether it was a risk factor for the ADR.
|
6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
Number of Participants With Adverse Drug Reactions by Diagnosis
Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules.
Relatedness to MYCOBUTIN Capsules was assessed by the physician.
Participants with ADRs were counted by diagnosis to assess whether it was a risk factor for the ADR.
|
6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
|
Clinical Response Rate (Therapeutic)
Time Frame: 6.5 years (at maximum)
|
Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable.
The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response.
|
6.5 years (at maximum)
|
Clinical Response Rate (Therapeutic) by Gender
Time Frame: 6.5 years (at maximum)
|
Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable.
The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response.
Participants who achieved clinical response by gender were counted to assess whether it contributed to clinical response.
|
6.5 years (at maximum)
|
Clinical Response Rate (Therapeutic) by Age
Time Frame: 6.5 years (at maximum)
|
Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable.
The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response.
Participants who achieved clinical response by age were counted to assess whether it contributed to clinical response.
|
6.5 years (at maximum)
|
Clinical Response Rate (Therapeutic) by Diagnosis
Time Frame: 6.5 years (at maximum)
|
Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable.
The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response.
Participants who achieved clinical response by diagnosis were counted to assess whether it contributed to clinical response.
|
6.5 years (at maximum)
|
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
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Slow Virus Diseases
- Mycobacterium Infections, Nontuberculous
- HIV Infections
- Infections
- Mycobacterium Infections
- Tuberculosis
- Acquired Immunodeficiency Syndrome
- Mycobacterium avium-intracellulare Infection
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antitubercular Agents
- Antibiotics, Antitubercular
- Rifabutin
Other Study ID Numbers
- A0061007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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