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Trial record 1 of 1 for:    NCT00810407
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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
Results First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 9, 2008
First Posted Date December 18, 2008
Results First Submitted Date May 18, 2017
Results First Posted Date March 7, 2019
Last Update Posted Date March 7, 2019
Actual Study Start Date November 2008
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2018)
  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: 1 year ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator.
  • Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: 1 year ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Mycobutin was assessed by the physician/investigator.
  • Number of Participants With Treatment-Related Adverse Events by Diagnosis [ Time Frame: 1 year ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by diagnosis to assess whether they were risk factors for the treatment related adverse events.
  • Number of Participants With Treatment-Related Adverse Events by Gender [ Time Frame: 1 year ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether they were risk factors for the treatment related adverse events.
  • Number of Participants With Treatment-Related Adverse Events by Age [ Time Frame: 1 year ]
    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether they were risk factors for the treatment related adverse events.
  • Clinical Efficacy Rate [ Time Frame: 1 year ]
    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values.
  • Clinical Efficacy Rate by Diagnosis [ Time Frame: 1 year ]
    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by diagnosis were counted to assess whether they contribute to the clinical effectiveness.
  • Clinical Efficacy Rate by Gender [ Time Frame: 1 year ]
    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by gender were counted to assess whether they contribute to the clinical effectiveness.
  • Clinical Efficacy Rate by Age [ Time Frame: 1 year ]
    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by age were counted to assess whether they contribute to the clinical effectiveness.
Original Primary Outcome Measures
 (submitted: December 17, 2008)
  • 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 ]
Change History Complete list of historical versions of study NCT00810407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
Official Title Special Investigation For Non-hiv Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A0061006 prescribes the Mycobutin®).
Condition
  • Tuberculosis
  • Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Intervention 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.
Study Groups/Cohorts rifabutin
Patients administered Rifabutin.
Intervention: Drug: rifabutin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 12, 2018)
628
Original Estimated Enrollment
 (submitted: December 17, 2008)
500
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Mycobutin®.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00810407
Other Study ID Numbers A0061006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018