A Pilot, Randomized Study Comparing the Safety, Tolerability and Pharmacokinetics of Combination Therapy (Amantadine, Ribavirin, Oseltamivir) Versus Neuraminidase Inhibitor Monotherapy to Influenza Virus Infected Immunocompromised Patients
Sponsor study identifier
Secondary identifiers
OTHER · FHCRC/UW CC IRB
interventional
7
1 country
2
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Completion
January 2010
Actual (reported)The purpose of this study is to assess the safety and tolerability of triple combination antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and to gain data on the effectiveness of TCAD
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
March 20, 2009
Actual (reported)March 23, 2009
Actual (reported)August 2009
Actual (reported)January 2010
Actual (reported)June 4, 2013
Actual (reported)Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption
Abnormal lab data or newly appeared symptoms \& signs were considered as AEs. Examined lab data: Blood cell count (WBC, differential count, Red Blood Cell (RBC), Hemoglobin, Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), platelets), Chemistry (Cl, bicarbonate (HCO3), K, Na), Renal function test (BUN, Creatinine, Creatinine clearance), Liver function test (AST, Alanine aminotransferase(ALT), T.Bil, gamma-glutamyltransferase)
30 days after the final dose of study drug
Number of Participants With Viral Load Decrease as a Function of Time
baseline and 28 days
Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1
10 days
Number of Participants With Viral Resistance as a Function of Drug Exposure
28 days
Duration of Symptoms
from baseline up to 28 days
Frequency of Confirmed Pneumonia
58 days
TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate)
Zanamivir or Oseltamivir
TCAD for subjects who cannot tolerate or are ineligible to receive zanamivir
TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate)
Zanamivir or Oseltamivir
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Zanamivir or Oseltamivir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordSeattle Children's
Seattle, Washington, 98105, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Seo S, Englund JA, Nguyen JT, Pukrittayakamee S, Lindegardh N, Tarning J, Tambyah PA, Renaud C, Went GT, de Jong MD, Boeckh MJ. Combination therapy with amantadine, oseltamivir and ribavirin for influenza A infection: safety and pharmacokinetics. Antivir Ther. 2013;18(3):377-86. doi: 10.3851/IMP2475. Epub 2012 Dec 21.
Study was terminated. Limitations of this study include: small sample size pilot study; inability to enroll the projected number of patients for full analysis before the study was terminated.
Michael Boeckh, MD
Fred Hutchinson Cancer Center
7 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2009
First Posted
March 23, 2009
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
TCAD(amantadine hydrocholoride, ribavirin and oseltamivir phosphate)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2009
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
August 15, 2013
Results First Posted
June 4, 2013
Record last verified: 2013-08
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Source: ClinicalTrials.gov.
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