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NCT00979251 Clinical Trial

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

Influenza Clinical Trial

— PO206  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00979251
Other study ID # ADS-TCAD-PO206
Secondary ID
Status Completed
Phase Phase 2
First received September 16, 2009
Last updated March 17, 2014
Start date September 2009
Est. completion date August 2011

Study information
Verified date March 2014
Source Adamas Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaSingapore: Health Sciences AuthorityNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Oseltamivir Phosphate
Oseltamivir Phosphate, q8h
• ADS-8902
Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Adamas Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Netherlands,  Singapore, 

Outcome
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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