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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Tuberculosis Non-tuberculous Mycobacterial Diseases (Including MAC Disease) Drug: rifabutin

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 Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Rifabutin
U.S. FDA Resources

Group/Cohort Intervention/treatment
rifabutin
Patients administered Rifabutin.
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.



Primary Outcome Measures :
  1. Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 1 year ]
  2. The incidence of adverse drug reactions in this surveillance. [ Time Frame: 1 year ]
  3. Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients whom an investigator involving A0061006 prescribes the Mycobutin®).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Mycobutin®.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00810407     History of Changes
Other Study ID Numbers: A0061006
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents