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Trial record 1 of 1 for:    NCT00802854
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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00802854
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : November 30, 2017
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 3, 2008
First Posted Date December 5, 2008
Results First Submitted Date May 17, 2017
Results First Posted Date November 30, 2017
Last Update Posted Date November 21, 2018
Actual Study Start Date March 2, 2012
Actual Primary Completion Date May 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2018)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
  • Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
  • Duration of Adverse Events (AEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time (in days) from onset of adverse event till the event is resolved in participants who had at least 1 AE.
  • Number of Adverse Events (AEs) by Severity [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
  • Number of Participants With Outcome in Response to Adverse Events (AEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes' (when AE was still present), 'unknown' (no information) or 'no, resolved' (when AE was not present and was resolved).
  • Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    AE=any untoward medical occurrence attributed to study drug in participant who received study drug. Treatment-emergent AE=AE between first dose of study drug up to 28 days after last dose that were absent before treatment/worsened relative to pretreatment state. Relatedness of AE to treatment assessed by physician as:Certain=clinically reasonable reaction on cessation of treatment;Probable/likely=followed reasonable time sequence from administration of treatment which was not explained by other drug/chemical substance/accompanying disease;Possible=followed reasonable time sequence from administration of treatment;Unlikely=not likely to have reasonable causal relationship with treatment, seems temporary;Conditional/unclassified=needed more data to make appropriate assessment/its additional data were being reviewed;Unaccessible/unclassifiable=lack of sufficient information hampered accurate causality assessment. % of AEs=(Number of AEs for specified categories/total number of AEs)*100.
  • Number of Participants With Laboratory Abnormalities [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein). Laboratory abnormalities were identified by the Investigator.
  • Number of Participants With Clinical Response (CR) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    CR was categorized as: a) Cure: resolution of signs and symptoms attributed to Candida infection; b) Improvement: significant, but incomplete resolution of signs and symptoms of the Candida infection c) Failure: no significant improvement in signs and symptoms of Candida infection, or death due to the Candida infection; d) Unevaluable: evaluation was not made due to withdrawal of participant from the study prior to assessment of cure or failure, or when lost to follow-up.
  • Number of Participants With Mycological Response (MR) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    In case cultivation was performed, isolated pathogens before and after administration of Eraxis were recorded and MR outcomes after Eraxis administration were evaluated. MR was evaluated as: a) Eradication: baseline pathogen not isolated from original site culture; b) Presumed eradication: culture data did not exist and CR was defined as cure(resolution of signs and symptoms attributed to Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection); c) Persistence: any baseline Candida species was present in repeat culture; d) Presumed persistence: culture data did not exist and CR was defined as failure (no significant improvement in signs and symptoms of Candida infection, or death due to Candida infection); e) Unevaluable: when culture data did not exist; and f) Superinfection: emergence of new Candida infection at original site of infection or at distant infection site.
  • Number of Participants With Overall Response (OR) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    OR: final effectiveness evaluation analyzed using following criteria (based on physician's evaluation of CR & MR): a)Effective:clinical success (cure/improvement) & microbiological success (eradication/presumed eradication), b)Ineffective:clinical failure/microbiological failure (persistence/presumed persistence); c)Unevaluable:unevaluable CR & MR & neither response was failure. CR:cure (resolutions of symptom), improvement (significant but incomplete resolution of sign/symptom), failure (no significant improvement/death), Unevaluable:no evaluation as participant withdrew prior assessment of cure/failure/lost to follow-up. MR:eradication (baseline pathogen not isolated from original site culture); presumed eradication(culture data not exist & CR of cure/improvement); persistence (baseline Candida species present in repeat culture); presumed persistence (culture data not exist;CR defined as failure), unevaluable:culture data not exist, superinfection:emergence of new Candida infection.
Original Primary Outcome Measures
 (submitted: December 3, 2008)
  • Endpoint on Final efficacy. - Mycological outcome. - Global response (consisting of a combination of both clinical and mycological response). [ Time Frame: over the study period ]
  • Endpoint on Safety. - Incidence of adverse event. - Others, abnormal finding from laboratory test (if any). [ Time Frame: through the study period ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: December 3, 2008)
  • Unexpected adverse event (especially, occurrence of serious adverse events). [ Time Frame: over the study period ]
  • The circumstantial factor of adverse event appearing under after maintained certain drug. [ Time Frame: over the study period ]
  • Factors affecting safety. [ Time Frame: over the study period ]
  • Factors affecting efficacy. [ Time Frame: over the study period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
Official Title Post Marketing Surveillance Study To Observe Safety And Effectiveness Of Eraxis (Registered) Iv.
Brief Summary The objective of this study is to collect the safety and efficacy data of Eraxis IV (anidulafungin) 100 mg according to Korea Ministry of Food and Drug Safety regulations.
Detailed Description

The objective of this study is to determine any problems or questions associated with Eraxis after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination Guideline of New Drugs".

  1. Serious adverse event/adverse drug reaction
  2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
  3. Known adverse drug reaction
  4. Non-serious adverse drug reaction
  5. Other safety and effectiveness information Eraxis was first approved as a new medicine on 30 May 2008. As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug(until 29 May 2014).

However, minimal required number of subjects was not met during the original reexamination period (30 May 2008 ~ 29 May 2014). Therefore, according to an order from MFDS on 02 Mar 2015, Eraxis PMS was requested to collect the rest of required subjects by 02 September 2016 in prospective and retrospective approach.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

200 subjects will be studied according to the review result by the MFDS for the request for the adjustment of number of subjects.

To achieve the target sample size, the study is being conducted in prospective study design and retrospective study design.

  1. Prospective Study -Subjects will be enrolled by continuous registration method.
  2. Retrospective Study -Physician should enroll patients consecutively who had received at least one dose of Eraxis IV after Eraxis IV approval date (30 May 2008).
Condition
  • Candidemia
  • Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)
Intervention Not Provided
Study Groups/Cohorts Not Provided
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: June 27, 2016)
244
Original Estimated Enrollment
 (submitted: December 3, 2008)
3000
Actual Study Completion Date May 20, 2016
Actual Primary Completion Date May 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria
  1. Prospective Study Population 1.1. Inclusion Criteria

    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

    • Use in the treatment of invasive candidiasis in adult patients
    • Evidence of a personally signed and dated data privacy statement indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

    1.2. Exclusion Criteria

    Subjects presenting with any of the following will not be included in the study:

    • Subjects to whom Eraxis IV is prescribed for other diseases than invasive candidiasis in adult patients.
    • Subjects less than 18 ages should be excluded in this study since safety and effectiveness in pediatric patients have not been established yet.
    • Hypersensitivity to the active substance, or to any of the excipients.
    • Hypersensitivity to other medicinal products of the echinocandin class (e.g. caspofungin).
  2. Retrospective Study Population 2.1. Inclusion Criteria

Subjects must meet one of the following inclusion criteria to be eligible for enrollment into the study:

Since all subjects enrolled should meet the usual prescribing criteria as per the local product document of Eraxis IV at the time of starting Eraxis IV administration, the inclusion criteria is divided as followings on the basis of 10 Mar 2015 when the approved indication was updated.

  • In case where the starting date of Eraxis IV administration is prior to 10 Mar 2015 - Use in the treatment of the following fungal infections: candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis)
  • In case where the starting date of Eraxis IV administration is 10 Mar 2015 or after - Use in the treatment of invasive candidiasis in adult patients 2.2. Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:

  • Subjects to whom Eraxis IV was prescribed for other diseases than candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis) (in case where the starting date of Eraxis IV administration is prior to 10 Mar 2015) or invasive candidiasis in adult patients (in case where the starting date of Eraxis IV administration is 10 Mar 2015 or after).
  • Subjects less than 18 ages should be excluded in this study since safety and effectiveness in pediatric patients have not been established yet.
  • Hypersensitivity to the active substance, or to any of the excipients.
  • Hypersensitivity to other medicinal products of the echinocandin class (e.g. caspofungin).
  • Subjects enrolled in the prospective phase study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00802854
Other Study ID Numbers A8851025
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 October 2018