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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR OSELTAMIVIR PHOSPHATE

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Clinical Trials for Oseltamivir Phosphate

Trial ID Title Status Sponsor Phase Summary
NCT00453999 Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza Completed BioCryst Pharmaceuticals Phase 2 This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.
NCT00803595 A Multinational Phase III Study of CS-8958 (MARVEL) Completed Daiichi Sankyo Co., Ltd. Phase 3 The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures. In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.
NCT01010087 Trial Comparing High Versus Standard Dose Oseltamivir in Severe Influenza Infection in ICU Terminated Hoffmann-La Roche Phase 2 Primary Objectives: The primary objective of the trial is to compare the antiviral efficacy of a 10 day course of standard (75 mg bid) and high-dose (225 mg bid) oseltamivir (or equivalent doses in mild-moderate renal failure) in the treatment of severe influenza infections. The hypothesis is that high dose oseltamivir will increase the proportion of patients with negative reverse transcriptase (RT)-PCR detection of influenza viral RNA (and viral culture, at selected sites) at Day 5 post-treatment. An important secondary objective of the trial, which reflects the main clinical objective, is to determine the difference in the numbers of ventilator days between the standard-dose and high-dose groups
NCT01010087 Trial Comparing High Versus Standard Dose Oseltamivir in Severe Influenza Infection in ICU Terminated University of Manitoba Phase 2 Primary Objectives: The primary objective of the trial is to compare the antiviral efficacy of a 10 day course of standard (75 mg bid) and high-dose (225 mg bid) oseltamivir (or equivalent doses in mild-moderate renal failure) in the treatment of severe influenza infections. The hypothesis is that high dose oseltamivir will increase the proportion of patients with negative reverse transcriptase (RT)-PCR detection of influenza viral RNA (and viral culture, at selected sites) at Day 5 post-treatment. An important secondary objective of the trial, which reflects the main clinical objective, is to determine the difference in the numbers of ventilator days between the standard-dose and high-dose groups
NCT01130636 Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation Completed Hoffmann-La Roche Phase 4 The main purpose of this study is to assess the potential exposure of neonates to oseltamivir during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast milk in breastfeeding women who are treated with oseltamivir, an anti-flu medication.
NCT01130636 Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation Completed Pharmahungary Group Phase 4 The main purpose of this study is to assess the potential exposure of neonates to oseltamivir during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast milk in breastfeeding women who are treated with oseltamivir, an anti-flu medication.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Oseltamivir Phosphate

Condition Name

Condition Name for Oseltamivir Phosphate
Intervention Trials
Influenza 5
Influenza A Virus 1
Immune Thrombocytopenia 1
Human Influenza 1
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Condition MeSH

Condition MeSH for Oseltamivir Phosphate
Intervention Trials
Influenza, Human 7
Thrombocytopenia 1
Purpura, Thrombocytopenic, Idiopathic 1
Metabolic Diseases 1
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Clinical Trial Locations for Oseltamivir Phosphate

Trials by Country

Trials by Country for Oseltamivir Phosphate
Location Trials
United States 27
South Africa 7
Canada 7
Australia 5
China 2
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Trials by US State

Trials by US State for Oseltamivir Phosphate
Location Trials
New Jersey 2
Massachusetts 1
Arkansas 1
California 1
Colorado 1
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Clinical Trial Progress for Oseltamivir Phosphate

Clinical Trial Phase

Clinical Trial Phase for Oseltamivir Phosphate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Oseltamivir Phosphate
Clinical Trial Phase Trials
Completed 4
Recruiting 2
Terminated 2
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Clinical Trial Sponsors for Oseltamivir Phosphate

Sponsor Name

Sponsor Name for Oseltamivir Phosphate
Sponsor Trials
Hoffmann-La Roche 3
Hospital Nacional San Juan de Dios de Santa Ana, El Salvador 1
University of Toronto 1
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Sponsor Type

Sponsor Type for Oseltamivir Phosphate
Sponsor Trials
Other 15
Industry 6
U.S. Fed 1
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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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Fish and Richardson

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