TCAD vs. Monotherapy for Influenza A in Immunocompromised Patients
This study has been completed.
Sponsor:
Fred Hutchinson Cancer Research Center
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00867139
First received: March 20, 2009
Last updated: July 19, 2011
Last verified: July 2011
Tracking Information | |||||
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First Received Date ICMJE | March 20, 2009 | ||||
Last Updated Date | July 19, 2011 | ||||
Start Date ICMJE | March 2009 | ||||
Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: 58 days ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00867139 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | TCAD vs. Monotherapy for Influenza A in Immunocompromised Patients | ||||
Official Title ICMJE | |||||
Brief Summary | The purpose of this study is to assess the safety and tolerability of triple combination antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and to gain data on the effectiveness of TCAD |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Influenza | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 70 | ||||
Completion Date | January 2010 | ||||
Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: i. Inclusion criteria for randomized arms (both needed):
ii. Inclusion criteria for open-label arm (at least one criteria required):
1. Able to provide informed consent, or for whom consent may be provided by guardian 2. Immunocompromised, as defined by one of the following:
Exclusion Criteria(all subjects):
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Gender | Both | ||||
Ages | 1 Year and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00867139 | ||||
Other Study ID Numbers ICMJE | 2323.00, 6895 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Michael Boeckh, MD, Associate Member, Fred Hutchinson Cancer Research Center | ||||
Study Sponsor ICMJE | Fred Hutchinson Cancer Research Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Fred Hutchinson Cancer Research Center | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |