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Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00810407
First received: December 9, 2008
Last updated: May 15, 2013
Last verified: May 2013
History of Changes

December 9, 2008
May 15, 2013
November 2008
September 2013   (final data collection date for primary outcome measure)
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00810407 on ClinicalTrials.gov Archive Site
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Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
Special Investigation For Non-HIV Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan)

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

The patients whom an investigator involving A0061006 prescribes the Mycobutin®).
  • Tuberculosis
  • Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Drug: 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.
rifabutin
Patients administered Rifabutin.
Intervention: Drug: rifabutin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
500
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Mycobutin®.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00810407
A0061006
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP