CLINICAL TRIALS PROFILE FOR PERAMIVIR
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All Clinical Trials for peramivir
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00297050 ↗ | Safety and Dose Study of Peramivir for Influenza Treatment | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 2006-02-23 | This study will evaluate the safety and tolerability of peramivir, a new drug to treat influenza. The study will administer gradually increasing doses of the drug in successive small groups of subjects to determine the optimal dose that is safe and well tolerated. It will be studied first at a single dose and then in multiple doses. The study will also determine how long peramivir stays in the body and how high the drug levels are in the blood. Men and women 18 - 40 years of age who weigh at least 110 lbs. and have a body mass index (BMI) between 19 and 32 may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram (EKG), and blood and urine tests. Part I - Single Dose Escalation Participants are admitted to the NIH hospital for 32 to 40 hours for a single 15-minute intravenous infusion of peramivir or placebo (saline), followed by monitoring and evaluation. The drug dose is increased in successive groups of eight subjects; in each group, six subjects are given peramivir and two receive placebo. The first group receives 0.5 mg/kg of peramivir; subsequent groups receive increasingly higher doses (1, 2, 3.5, and 5 mg/kg) as long as the last dose was well tolerated by the preceding group. Blood samples are drawn and subjects are monitored for vital signs (temperature, blood pressure and heart rate) and for symptoms such as headache, nausea, shortness of breath or pain at 0.5, 1, 2, 3, 6, 9, 12, 18 and 24 hours after the drug infusion. At the 24-hour evaluation they have an EKG. If needed, an echocardiogram (ultrasound examination of the heart) may also be done. Subjects return to the clinic 2, 3, 7, 14, and 28 days after the infusion for a check of vital signs, review of symptoms, blood draw, and urine sample collection. In addition, subjects are asked to collect all their urine for the first 48 hours after the study drug infusion. Part II - Multi-dose Escalation Groups of 16 subjects receive an intravenous infusion of peramivir (12 subject) or placebo (4 subjects) once a day for 5 consecutive days. The first four infusions are given in the NIH outpatient clinic. The dose of peramivir is increased in successive groups of 16 subjects as long as the preceding dose was well tolerated. Before the infusion on day 1, subjects have a physical examination, blood test and EKG to obtain baseline values. After the infusion, they remain in the hospital for 6 hours. Vital signs and symptoms are c... |
| NCT00419263 ↗ | Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza. | Completed | BioCryst Pharmaceuticals | Phase 2 | 2007-01-01 | This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to be seen 5 more times after they are enrolled in the study. |
| NCT00453999 ↗ | Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza | Completed | BioCryst Pharmaceuticals | Phase 2 | 2007-07-01 | 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. |
| NCT00486980 ↗ | Intramuscular Peramivir for the Treatment of Uncomplicated Influenza | Withdrawn | BioCryst Pharmaceuticals | Phase 3 | 1969-12-31 | This is a multinational, randomized, double-blind study comparing the efficacy and safety of two single dose regimens of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza. |
| NCT00610935 ↗ | Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza | Terminated | BioCryst Pharmaceuticals | Phase 3 | 2008-01-01 | The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza. |
| NCT00705406 ↗ | A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza | Completed | BioCryst Pharmaceuticals | Phase 2 | 2008-07-01 | The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza. |
| NCT00957996 ↗ | Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza | Completed | Department of Health and Human Services | Phase 3 | 2009-10-01 | This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection. |
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