Safety And Efficacy Of Rifabutin In HIV Patients

Completed

• Conditions: Non-tuberculous Mycobacterial Diseases; Tuberculosis; Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
• Interventions: Drug: rifabutin

• Registration Number: NCT00810446
• Lead Sponsor: Pfizer

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed Description

All the patients whom an investigator prescribes the first Mycobutin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Timeline

• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Study Start: 2009-06
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Results First Submitted: 2019-02-08
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-13
• Last Update Submitted: 2019-06-13
• Results First Posted: 2019-08-02
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.

Exclusion Criteria

• Patients not administered Mycobutin®.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rifabutin	rifabutin	Patients administered Rifabutin.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Drug Reactions in This Surveillance	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.
Number of Participants With Adverse Drug Reactions by Diagnosis	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.
The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)	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.
Number of Participants With Adverse Drug Reactions by Gender	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.
Clinical Response Rate (Therapeutic) by Gender	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.
Number of Participants With Adverse Drug Reactions by Age	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.
Clinical Response Rate (Therapeutic) by Age	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.
Clinical Response Rate (Therapeutic)	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.
Clinical Response Rate (Therapeutic) by Diagnosis	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.