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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: September 8, 2014
Last verified: September 2014
  Purpose

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 Intervention
Tuberculosis
Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Drug: rifabutin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation For Non-HIV Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: November 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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®.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810407

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00810407     History of Changes
Other Study ID Numbers: A0061006
Study First Received: December 9, 2008
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014