A phase II, Multicenter, Randomised, Double-Mask, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects with Uncomplicated Acute Influenza

Phase 1

• Conditions: ncomplicated Acute Influenza; MedDRA version: 8.1 Level: LLT Classification code 10059637 Term: Influenza antibody test

• Registration Number: EUCTR2006-005196-17-GB
• Lead Sponsor: BioCryst Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. Age =18 years
2. Presence of fever at time of screening of =38.0 ºC (=100.4 ºF) taken orally, or =38.5 ºC (=101.2 ºF) taken rectally. However , this requirement is waived if subject has a history of fever in the 24 hours prior to screening and has administered antipyretic(s) in the 6 hours before screening.
3. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)
4. Presence of at least one constitutional symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) of any severity (mild, moderate, or severe)
5. Onset of illness no more than 48 hours before presentation. Note: Time of onset of illness is defined as either (1) the time when the temperature (either oral or rectal) was first measured as elevated (at least one ºC of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
6. Rapid Antigen Test (RAT) performed on an adequate specimen collected from the anterior nose (bilateral) and posterior pharynx (swab) is positive. A negative initial RAT may be repeated within one hour of obtaining a negative result. A second negative RAT result will exclude the subject from evaluation for enrollment.
7. Females of childbearing potential must report one of the following:
- Be surgically sterile
- Have been sexually abstinent 4 weeks prior to date of screening evaluation and be willing to remain abstinent through 4 weeks after study drug administration
- Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches and have been using these for 3 months prior through 4 weeks after study drug administration
- Use an intra-uterine device (IUD), or adequate barrier contraception (or double-barrier method such as condom or diaphragm with spermicidal gel or foam) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Women who are breast-feeding
2. History of chronic obstructive pulmonary disease or other chronic respiratory disease requiring daily pharmacotherapy
3. History of chronic renal impairment requiring hemodialysis or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min)
4. History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class II, III, or IV within the past 12 months
5. Immunocompromised status due to illness or previous organ transplant
6. Current use of systemic immunosuppressive medications or treatments
7. Use of rimantadine, amantadine, zanamivir, or oseltamivir in the past 7 days
8. Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days
9. Clinical evidence of active bacterial infection at any body site requiring therapy with oral or systemic antibiotics
10. Clinically significant signs of acute respiratory distress
11. Clinically significant signs of acute cardiac disease
12. Screening ECG which suggests acute or chronic ischemia and/or medically significant dysrhythmia
13. Presence of a chronic disease or illness(es) with either clinical or historical evidence of recent exacerbation of such disease(s) or illness(es) or lack of control of such disease(s) or illness(es)
14. History of hepatitis B, hepatitis C, or human immunodeficiency virus infection
15. History of alcohol abuse or drug addiction within 1 year prior to admission in the study
16. Participation in a study of any investigational drug within the last 30 days
17. Positive urine pregnancy test

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of peramivir administered intramuscularly compared to placebo in adult subjects with uncomplicated acute influenza.;Secondary Objective: To evaluate the safety and tolerability of peramivir administered intramuscularly compared to placebo in adult subjects with uncomplicated acute influenza.;Primary end point(s): Clinical: Time to alleviation of symptoms.