Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00979251




Registration number
NCT00979251
Ethics application status
Date submitted
16/09/2009
Date registered
17/09/2009
Date last updated
14/04/2014

Titles & IDs
Public title
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
Scientific 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
Secondary ID [1] 0 0
ADS-TCAD-PO206
Universal Trial Number (UTN)
Trial acronym
PO206
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oseltamivir Phosphate
Treatment: Drugs - ADS-8902

Experimental: ADS-8902 - Amantadine and Ribavirin administered with Oseltamivir phosphate

Active Comparator: Comparator - Oseltamivir Phosphate


Treatment: Drugs: Oseltamivir Phosphate
Oseltamivir Phosphate, q8h

Treatment: Drugs: ADS-8902
Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to clearing of viral shedding
Timepoint [1] 0 0
Baseline, Days 2, 4, 6, 8, 10, 15 and 20
Secondary outcome [1] 0 0
Time to alleviation of influenza clinical symptoms
Timepoint [1] 0 0
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Secondary outcome [2] 0 0
Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza
Timepoint [2] 0 0
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Secondary outcome [3] 0 0
Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment
Timepoint [3] 0 0
Baseline, Days 2, 4, 6, 8, 10, 15, 20
Secondary outcome [4] 0 0
Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)
Timepoint [4] 0 0
Through day 210

Eligibility
Key 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
Minimum age
1 Year
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Adamas Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Adamas Investigational Site - Herston
Recruitment hospital [3] 0 0
Adamas Investigational Site - Sydney
Recruitment hospital [4] 0 0
Adamas Investigative Site - Parkville
Recruitment hospital [5] 0 0
Adamas Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [3] 0 0
QLD 4029 - Sydney
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
South Dakota
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Netherlands
State/province [14] 0 0
Leiden
Country [15] 0 0
Singapore
State/province [15] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Adamas Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00979251
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00979251