Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
This study has been completed.
Information provided by (Responsible Party):
First received: December 9, 2008
Last updated: September 20, 2016
Last verified: September 2016
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.
Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
||Observational Model: Case-Only
Time Perspective: Prospective
||Special Investigation For Non-hiv Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).
Primary Outcome Measures:
- Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 1 year ]
- The incidence of adverse drug reactions in this surveillance. [ Time Frame: 1 year ]
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 1 year ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2016 (Final data collection date for primary outcome measure)
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 Name: Mycobutin.
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.
|Ages Eligible for Study:
||Child, Adult, Senior
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
The patients whom an investigator involving A0061006 prescribes the Mycobutin®).
- Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.
- Patients not administered Mycobutin®.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00810407
||Pfizer CT.gov Call Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 9, 2008
||September 20, 2016
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 17, 2017
Gram-Positive Bacterial Infections