InfluenzaPhase 2PO206NCT00979251
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
A Phase 2 study testing Oseltamivir Phosphate and ADS-8902 in people with Influenza, run by Adamas Pharmaceuticals, Inc. at 25 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- Oseltamivir Phosphate and ADS-8902
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 25 sitesin 5 countries
- Study dates
- Sep 2009to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United States16 sites
Adamas Investigational Site
Amarillo, Texas
Adamas Investigational Site
Hollywood, Florida
Adamas Investigational Site
Honolulu, Hawaii
Adamas Investigational Site
Las Vegas, Nevada
Adamas Investigational Site
Memphis, Tennessee, 38105
Adamas Investigational Site
Miramar, Florida
Adamas Investigational Site
New Orleans, Louisiana
Adamas Investigational Site
New York, New York
Adamas Investigational Site
Owensboro, Kentucky
Adamas Investigational Site
Pinellas Park, Florida
Adamas Investigational Site
Rapid City, South Dakota, 57702
Adamas Investigational Site
San Francisco, California, 94114
Adamas Investigational Site
San Francisco, California, 94115
Adamas Investigational Site
San Francisco, California
Adamas Investigational Site
Seattle, Washington
Adamas Investigational Site
Tacoma, Washington
Australia5 sites
Adamas Investigational Site
Darlinghurst, New South Wales, NSW 2010
Adamas Investigational Site
Herston, New South Wales, QLD 4029
Adamas Investigational Site
Melbourne
Adamas Investigative Site
Parkville, Victoria, 3050
Adamas Investigational Site
Sydney, New South Wales, QLD 4029
Canada2 sites
Adamas Investigational Site
Edmonton, Alberta
Adamas Investigational Site
Toronto, Ontario
About this study
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
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.
- Conditions
- Influenza
- Being tested
- Oseltamivir Phosphate, ADS-8902
- Keywords
- Influenza, Immunocompromised, HIV, History of transplant
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oseltamivir PhosphateDrug
Also called Tamiflu
Oseltamivir Phosphate, q8h
ADS-8902Drug
Also called Amantadine Hydrochloride, Rebetol®, Tamiflu®
Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
| Study group | Role | What they receive |
|---|---|---|
| ADS-8902 | Experimental | Amantadine and Ribavirin administered with Oseltamivir phosphate Receives: Drug: ADS-8902 |
| Comparator | Active comparator | Oseltamivir Phosphate Receives: Drug: Oseltamivir Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clearing of viral shedding
Measured: Baseline, Days 2, 4, 6, 8, 10, 15 and 20
Secondary outcomes (4)
Time to alleviation of influenza clinical symptoms
Measured: 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
Measured: 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
Measured: Baseline, Days 2, 4, 6, 8, 10, 15, 20
Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)
Measured: Through day 210
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adamas Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979251
- Sponsor's protocol ID
- ADS-TCAD-PO206
- Acronym
- PO206
- Status last verified
- Mar 2014
- First submitted
- 16 Sep 2009
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00979251
- Acronym / sponsor ID
- PO206 / ADS-TCAD-PO206
- Conditions
- Influenza
- Keywords
- Influenza, Immunocompromised, HIV, History of transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Adamas Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADS-8902 | Experimental | Drug: ADS-8902Amantadine and Ribavirin administered with Oseltamivir phosphate |
| Comparator | Active comparator | Drug: Oseltamivir PhosphateOseltamivir Phosphate |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oseltamivir PhosphateAlso: TamifluOseltamivir Phosphate, q8h | Drug | Comparator |
| ADS-8902Also: Amantadine Hydrochloride, Rebetol®, Tamiflu®Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h | Drug | ADS-8902 |
Primary outcome
Time to clearing of viral shedding
Time frame: Baseline, Days 2, 4, 6, 8, 10, 15 and 20
4 secondary outcomes
Time to alleviation of influenza clinical symptoms
Time frame: 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
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
Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)
Time frame: Through day 210
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oseltamivir Phosphate and ADS-8902 in people with Influenza, run by Adamas Pharmaceuticals, Inc. at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Australia, Canada, Netherlands, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clearing of viral shedding (time frame: Baseline, Days 2, 4, 6, 8, 10, 15 and 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.