NCT00979251

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Adamas Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 1 Year – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Oseltamivir Phosphate	Oseltamivir Phosphate, q8h
DRUG	ADS-8902	Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-05-01
• Completion: 2011-08-01
• First posted: 2009-09-17
• Last updated: 2014-04-14

Locations

25 sites across 5 countries: United States, Australia, Canada, Netherlands, Singapore