Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
NCT ID: NCT00979251
Last Updated: 2014-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
2 participants
INTERVENTIONAL
2009-09-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ADS-8902
Amantadine and Ribavirin administered with Oseltamivir phosphate
ADS-8902
Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
Comparator
Oseltamivir Phosphate
Oseltamivir Phosphate
Oseltamivir Phosphate, q8h
Interventions
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Oseltamivir Phosphate
Oseltamivir Phosphate, q8h
ADS-8902
Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, HIV positive
* Clinical diagnosis of influenza
* Onset of illness within 5 days
* Male and female subjects agree to contraception through 24 weeks after last dose
Exclusion Criteria
* Critically ill
* Creatinine clearance less than 80 mg/mL
* Females who are pregnant and males whose female partners are pregnant
* Received live attenuated virus vaccine within 3 weeks
1 Year
65 Years
ALL
No
Sponsors
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Adamas Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Adamas Investigational Site
San Francisco, California, United States
Adamas Investigational Site
San Francisco, California, United States
Adamas Investigational Site
San Francisco, California, United States
Adamas Investigational Site
Hollywood, Florida, United States
Adamas Investigational Site
Miramar, Florida, United States
Adamas Investigational Site
Pinellas Park, Florida, United States
Adamas Investigational Site
Honolulu, Hawaii, United States
Adamas Investigational Site
Owensboro, Kentucky, United States
Adamas Investigational Site
New Orleans, Louisiana, United States
Adamas Investigational Site
Las Vegas, Nevada, United States
Adamas Investigational Site
New York, New York, United States
Adamas Investigational Site
Rapid City, South Dakota, United States
Adamas Investigational Site
Memphis, Tennessee, United States
Adamas Investigational Site
Amarillo, Texas, United States
Adamas Investigational Site
Seattle, Washington, United States
Adamas Investigational Site
Tacoma, Washington, United States
Adamas Investigational Site
Darlinghurst, New South Wales, Australia
Adamas Investigational Site
Herston, New South Wales, Australia
Adamas Investigational Site
Sydney, New South Wales, Australia
Adamas Investigative Site
Parkville, Victoria, Australia
Adamas Investigational Site
Melbourne, , Australia
Adamas Investigational Site
Edmonton, Alberta, Canada
Adamas Investigational Site
Toronto, Ontario, Canada
Adamas Investigational Site
Leiden, , Netherlands
Adamas Investigational Site
Singapore, , Singapore
Countries
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Other Identifiers
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ADS-TCAD-PO206
Identifier Type: -
Identifier Source: org_study_id
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