Phase II, Multicenter, Randomized, Double-Mask, Double-Dummy Study Comparing Efficacy and Safety of Intravenous Peramivir Once Daily Versus Oral Oseltamivir Twice Daily in Adults With Acute Serious or Potentially Life-Threatening Influenza

BioCryst Pharmaceuticals83 sites in 2 countries137 target enrollmentJuly 2007

ConditionsInfluenza

InterventionsPeramivir 200 mg Peramivir 400 mg Oseltamivir

DrugsPeramivir 200 mg Peramivir 400 mg Oseltamivir

Overview

Phase: Phase 2
Intervention: Peramivir 200 mg
Conditions: Influenza
Sponsor: BioCryst Pharmaceuticals
Enrollment: 137
Locations: 83
Primary Endpoint: Time to Clinical Stability (Kaplan-Meier Estimate)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

August 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BioCryst Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years of age, male or female
•Able to provide informed consent, or for whom consent may be provided by guardian
•Presence of fever at time of screening of ≥38.0°C (≥ 100.0°F) taken orally, or ≥38.5°C (≥101.2°F) taken rectally. This requirement is waived if the subject has (1) a history of fever within 24 hours prior to screening and administered any antipyretic(s) in the 24 hours prior to screening, or (2) has no history of documented fever as defined above, but reports a symptom of feverishness at some time during 48 hours prior to screening
•Presence of at least 1 respiratory symptom (cough, sore throat, nasal congestion/symptoms) of any severity (mild, moderate, severe)
•Presence of at least 1 constitutional symptom (headache, myalgia, feverishness, malaise, fatigue) of any severity (mild, moderate, severe)
•Onset of illness no more than 72 hours before presentation. Time of onset of illness defined as either (1) the time when temperature (oral or rectal) was elevated (at least 1°C of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least 1 respiratory symptom AND the presence of at least 1 constitutional symptom
•Presence of 1 or more of the following factors in a subject willing to be hospitalized for inpatient observation and treatment:
•Age ≥60 years
•Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy
•History of congestive heart failure with or without medically significant recent change in cardiac status, but without signs or symptoms compatible with NYHA Class IV functional status

Exclusion Criteria

•Immunized against influenza with live attenuated virus vaccine in the previous weeks
•Treatment with any dose(s) of rimantadine, amantadine, zanamivir, or oseltamivir in the previous 7 days
•Current clinical evidence of a recognized or suspected acute non-influenzal infectious illness with onset prior to Screening
•Serum creatinine laboratory result at Screening \>1.6 mg/dL or a result \>25% above the upper limit of normal for the laboratory performing the test
•History of clinically significant proteinuria (≥1000 mg/24 hrs)
•History of moderate or severe renal impairment and/or previous clinical laboratory data indicating an estimated creatinine clearance \<50 mL/min during the previous 12 months
•Electrocardiogram (ECG) at Screening visit showing evidence of acute ischemia, or presence of a medically significant dysrhythmia
•Presence of cardiac signs or symptoms compatible with NYHA Class III or Class IV functional status for congestive heart failure or angina (see NYHA Appendix V)
•Presence of diagnosed COPD or other chronic lung condition requiring either continuous or intermittent oxygen therapy as an outpatient. Note: Subjects who are determined to require acute supplemental oxygen therapy at the time of Screening and/or at hospital admission may be enrolled, if exclusion criteria #13 or #14 are not applicable.
•History of organ transplantation during the previous 12 months

Arms & Interventions

Arm 1: Peramivir 200 mg

Peramivir 200 mg administered intravenously once daily for 5 days (5 doses)

Intervention: Peramivir 200 mg

Arm 2: Peramivir 400 mg

Peramivir 400 mg administered intravenously once daily for 5 days (5 doses)

Intervention: Peramivir 400 mg

Arm 3: Oseltamivir

Oseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses)

Intervention: Oseltamivir

Outcomes

Primary Outcomes

Time to Clinical Stability (Kaplan-Meier Estimate)

Time Frame: 14 days

Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).

Secondary Outcomes

Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)(14 days)
Change From Baseline in Scores of Symptoms of Influenza(Baseline, Days 2, 3, 4, 5, 10, and 14)
Time to Hospital Discharge (Kaplan-Meier Estimate)(14 days)
Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)(14 days)
Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)(Baseline, and 12, 24, 36, 48, 72, and 96 hours)