Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
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|ClinicalTrials.gov Identifier: NCT00810407|
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : September 21, 2016
|Condition or disease||Intervention/treatment|
|Tuberculosis Non-tuberculous Mycobacterial Diseases (Including MAC Disease)||Drug: rifabutin|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Special Investigation For Non-hiv Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810407
|Study Director:||Pfizer CT.gov Call Center||Pfizer|