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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oseltamivir Phosphate
ADS-8902
Sponsored by
Adamas Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza, Immunocompromised, HIV, History of transplant

Eligibility Criteria

1 Year - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigative Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site
  • Adamas Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ADS-8902

Comparator

Arm Description

Amantadine and Ribavirin administered with Oseltamivir phosphate

Oseltamivir Phosphate

Outcomes

Primary Outcome Measures

Time to clearing of viral shedding

Secondary Outcome Measures

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)

Full Information

First Posted
September 16, 2009
Last Updated
March 17, 2014
Sponsor
Adamas Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00979251
Brief Title
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adamas Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Immunocompromised, HIV, History of transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADS-8902
Arm Type
Experimental
Arm Description
Amantadine and Ribavirin administered with Oseltamivir phosphate
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Oseltamivir Phosphate
Intervention Type
Drug
Intervention Name(s)
Oseltamivir Phosphate
Other Intervention Name(s)
Tamiflu
Intervention Description
Oseltamivir Phosphate, q8h
Intervention Type
Drug
Intervention Name(s)
ADS-8902
Other Intervention Name(s)
Amantadine Hydrochloride, Rebetol®, Tamiflu®
Intervention Description
Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
Primary Outcome Measure Information:
Title
Time to clearing of viral shedding
Time Frame
Baseline, Days 2, 4, 6, 8, 10, 15 and 20
Secondary Outcome Measure Information:
Title
Time to alleviation of influenza clinical symptoms
Time Frame
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Title
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
Title
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
Title
Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)
Time Frame
Through day 210

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Adamas Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Adamas Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Adamas Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Adamas Investigational Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Adamas Investigational Site
City
Miramar
State/Province
Florida
Country
United States
Facility Name
Adamas Investigational Site
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
Adamas Investigational Site
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Adamas Investigational Site
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Adamas Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Adamas Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Adamas Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Adamas Investigational Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Adamas Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Adamas Investigational Site
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
Adamas Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Adamas Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Adamas Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
NSW 2010
Country
Australia
Facility Name
Adamas Investigational Site
City
Herston
State/Province
New South Wales
ZIP/Postal Code
QLD 4029
Country
Australia
Facility Name
Adamas Investigational Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
QLD 4029
Country
Australia
Facility Name
Adamas Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Adamas Investigational Site
City
Melbourne
Country
Australia
Facility Name
Adamas Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Adamas Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Adamas Investigational Site
City
Leiden
Country
Netherlands
Facility Name
Adamas Investigational Site
City
Singapore
Country
Singapore

12. IPD Sharing Statement

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

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