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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00979251
First received: September 16, 2009
Last updated: March 17, 2014
Last verified: March 2014

September 16, 2009
March 17, 2014
September 2009
May 2010   (final data collection date for primary outcome measure)
Time to clearing of viral shedding [ Time Frame: Baseline, Days 2, 4, 6, 8, 10, 15 and 20 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00979251 on ClinicalTrials.gov Archive Site
  • Time to alleviation of influenza clinical symptoms [ Time Frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs) [ Time Frame: Through day 210 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Influenza
  • Drug: Oseltamivir Phosphate
    Oseltamivir Phosphate, q8h
    Other Name: Tamiflu
  • Drug: ADS-8902
    Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
    Other Names:
    • Amantadine Hydrochloride
    • Rebetol®
    • Tamiflu®
  • Experimental: ADS-8902
    Amantadine and Ribavirin administered with Oseltamivir phosphate
    Intervention: Drug: ADS-8902
  • Active Comparator: Comparator
    Oseltamivir Phosphate
    Intervention: Drug: Oseltamivir Phosphate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
August 2011
May 2010   (final data collection date for primary outcome measure)

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
Both
1 Year to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   Singapore
 
NCT00979251
ADS-TCAD-PO206
Yes
Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals, Inc.
Not Provided
Not Provided
Adamas Pharmaceuticals, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP