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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00979251