Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
NCT01073618
Last updated date
ABOUT THIS STUDY
This is non-interventional study of voriconazole IV formulation in clinical use, which was
mandated by the Korean government agency following the approval of Vfend in the Republic of
Korea.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Serious Fungal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Invasive aspergillosis and other serious fungal infections.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- N/A
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV | |||
| Official Title | Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV | |||
| Brief Summary | This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients who are indicated for VFEND according to drug package insert. | |||
| Condition | Serious Fungal Infections | |||
| Intervention | Drug: voriconazole IV
6 mg/kg iv q 12 hours (loading) then maintenance Other Name: Vfend | |||
| Study Groups/Cohorts | A.
Patients who are indicated for VFEND according to drug package insert. Intervention: Drug: voriconazole IV | |||
| 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 | 692 | |||
| Original Actual Enrollment | 696 | |||
| Actual Study Completion Date | October 2009 | |||
| Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 | NCT01073618 | |||
| Other Study ID Numbers | A1501067 | |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2012 | |||