Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
|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|
|Primary Completion Date :||July 2016|
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810407
|Study Director:||Pfizer CT.gov Call Center||Pfizer|