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Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects

Information source: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Oseltamivir Phosphate (Drug); ADS-8902 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Adamas Pharmaceuticals, Inc.

Summary

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to clearing of viral shedding

Secondary outcome:

Time to alleviation of influenza clinical symptoms

Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza

Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment

Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)

Eligibility

Minimum age: 1 Year. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Adamas Investigational Site, Melbourne, Australia

Adamas Investigational Site, Leiden, Netherlands

Adamas Investigational Site, Singapore, Singapore

Adamas Investigational Site, Edmonton, Alberta, Canada

Adamas Investigational Site, San Francisco, California 94114, United States

Adamas Investigational Site, San Francisco, California 94115, 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, Darlinghurst, New South Wales NSW 2010, Australia

Adamas Investigational Site, Herston, New South Wales QLD 4029, Australia

Adamas Investigational Site, Sydney, New South Wales QLD 4029, Australia

Adamas Investigational Site, New York, New York, United States

Adamas Investigational Site, Toronto, Ontario, Canada

Adamas Investigational Site, Rapid City, South Dakota 57702, United States

Adamas Investigational Site, Memphis, Tennessee 38105, United States

Adamas Investigational Site, Amarillo, Texas, United States

Adamas Investigative Site, Parkville, Victoria 3050, Australia

Adamas Investigational Site, Seattle, Washington, United States

Adamas Investigational Site, Tacoma, Washington, United States

Additional Information

Starting date: September 2009
Last updated: March 17, 2014

Page last updated: August 23, 2015

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