Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects (PO206)

March 17, 2014 updated by: Adamas Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Adamas Investigational Site
    • New South Wales
      • Darlinghurst, New South Wales, Australia, NSW 2010
        • Adamas Investigational Site
      • Herston, New South Wales, Australia, QLD 4029
        • Adamas Investigational Site
      • Sydney, New South Wales, Australia, QLD 4029
        • Adamas Investigational Site
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Adamas Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Adamas Investigational Site
    • Ontario
      • Toronto, Ontario, Canada
        • Adamas Investigational Site
  • Netherlands
      • Leiden, Netherlands
        • Adamas Investigational Site
  • Singapore
      • Singapore, Singapore
        • Adamas Investigational Site
  • United States
    • California
      • San Francisco, California, United States, 94114
        • Adamas Investigational Site
      • San Francisco, California, United States, 94115
        • Adamas Investigational Site
      • San Francisco, California, United States
        • Adamas Investigational Site
    • Florida
      • Hollywood, Florida, United States
        • Adamas Investigational Site
      • Miramar, Florida, United States
        • Adamas Investigational Site
      • Pinellas Park, Florida, United States
        • Adamas Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Adamas Investigational Site
    • Kentucky
      • Owensboro, Kentucky, United States
        • Adamas Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Adamas Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Adamas Investigational Site
    • New York
      • New York, New York, United States
        • Adamas Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Adamas Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Adamas Investigational Site
    • Texas
      • Amarillo, Texas, United States
        • Adamas Investigational Site
    • Washington
      • Seattle, Washington, United States
        • Adamas Investigational Site
      • Tacoma, Washington, United States
        • Adamas Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADS-8902
Amantadine and Ribavirin administered with Oseltamivir phosphate
Drug: ADS-8902
Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
Other Names:
  • Rebetol®
  • Tamiflu®
  • Amantadine Hydrochloride
Active Comparator: Comparator
Oseltamivir Phosphate
Drug: Oseltamivir Phosphate
Oseltamivir Phosphate, q8h
Other Names:
  • Tamiflu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to clearing of viral shedding
Time Frame: Baseline, Days 2, 4, 6, 8, 10, 15 and 20
Baseline, Days 2, 4, 6, 8, 10, 15 and 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to alleviation of influenza clinical symptoms
Time Frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza
Time Frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment
Time Frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20
Baseline, Days 2, 4, 6, 8, 10, 15, 20
Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)
Time Frame: Through day 210
Through day 210

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adamas Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 16, 2009

First Posted (Estimate)

September 17, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADS-TCAD-PO206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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