Influenza Clinical Trial
— PO206Official title:
A Randomized Open Label Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Amantadine and Ribavirin With Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects
This Phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects.
Status | Completed |
Enrollment | 2 |
Est. completion date | August 2011 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 65 Years |
Eligibility |
Inclusion Criteria: - Confirmed influenza A by rapid antigen testing - 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: - Received more than 1 dose of antiviral agents - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Adamas Investigational Site | Darlinghurst | New South Wales |
Australia | Adamas Investigational Site | Herston | New South Wales |
Australia | Adamas Investigational Site | Melbourne | |
Australia | Adamas Investigative Site | Parkville | Victoria |
Australia | Adamas Investigational Site | Sydney | New South Wales |
Canada | Adamas Investigational Site | Edmonton | Alberta |
Canada | Adamas Investigational Site | Toronto | Ontario |
Netherlands | Adamas Investigational Site | Leiden | |
Singapore | Adamas Investigational Site | Singapore | |
United States | Adamas Investigational Site | Amarillo | Texas |
United States | Adamas Investigational Site | Hollywood | Florida |
United States | Adamas Investigational Site | Honolulu | Hawaii |
United States | Adamas Investigational Site | Las Vegas | Nevada |
United States | Adamas Investigational Site | Memphis | Tennessee |
United States | Adamas Investigational Site | Miramar | Florida |
United States | Adamas Investigational Site | New Orleans | Louisiana |
United States | Adamas Investigational Site | New York | New York |
United States | Adamas Investigational Site | Owensboro | Kentucky |
United States | Adamas Investigational Site | Pinellas Park | Florida |
United States | Adamas Investigational Site | Rapid City | South Dakota |
United States | 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 | Seattle | Washington |
United States | Adamas Investigational Site | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Adamas Pharmaceuticals, Inc. |
United States, Australia, Canada, Netherlands, Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to clearing of viral shedding | Baseline, Days 2, 4, 6, 8, 10, 15 and 20 | Yes | |
Secondary | Time to alleviation of influenza clinical symptoms | Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38 | No | |
Secondary | Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza | Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38 | Yes | |
Secondary | Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment | Baseline, Days 2, 4, 6, 8, 10, 15, 20 | Yes | |
Secondary | Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs) | Through day 210 | Yes |
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