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

Phase 2

Completed

• Conditions: Acute, Uncomplicated Human Influenza
• Interventions: Drug: Placebo; Drug: Peramivir

• Registration Number: NCT00705406
• Lead Sponsor: BioCryst Pharmaceuticals

Brief Summary

The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Study Start: 2008-07
• Primary Completion: 2009-04
• Study Completion: 2009-10
• Disposition First Submitted: 2012-08-06
• Disposition First Submitted QC: 2012-08-06
• Disposition First Posted: 2012-08-15
• Results First Submitted: 2015-01-16
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-12
• Last Update Submitted: 2015-02-12
• Results First Posted: 2015-02-16
• Last Update Posted: 2015-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

• Male and non-pregnant female subjects age ≥18 years.
• A positive Influenza A or B Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer's instructions. A negative initial RAT should be repeated within one hour.
• 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. A subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at the time of screening.
• Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity.
• Presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of at least moderate severity.
• Onset of symptoms no more than 36 hours before presentation for screening.
• Written informed consent.

Exclusion Criteria

• Women who are pregnant or breast-feeding.
• Presence of clinically significant signs of acute respiratory distress
• History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma.
• History of heart failure or angina requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
• Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia.
• History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min).
• Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza.
• Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics.
• Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening.
• Currently receiving treatment for viral hepatitis B or viral hepatitis C.
• Presence of known HIV infection with a CD4 count <350 cell/mm3.
• Current therapy with oral warfarin or other systemic anticoagulant.
• Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
• Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days.
• Immunized against influenza with inactivated virus vaccine within the previous 14 days.
• Receipt of any intramuscular injection with the previous 7 days.
• History of alcohol abuse or drug addiction within 1 year prior to admission in the study.
• Participation in a previous study of intramuscular or intravenous peramivir or previous participation in this study.
• Participation in a study of any investigational drug or device within the last 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir	600 mg peramivir administered as bilateral 2-mL intramuscular injection.

Primary Outcome Measures

Name	Time	Method
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)	Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14	The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.

Secondary Outcome Measures

Name	Time	Method
Change in Influenza Virus Shedding	Baseline and Days 3, 4, 9	Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL \>0.5).

Trial Locations

Locations (121)

Mercury Street Medical Group, PLLC; 🇺🇸 Butte, Montana, United States

West Houston Clinical Research; 🇺🇸 Houston, Texas, United States

Holdsworth House Medical Practice; 🇦🇺 Darlinghurst, Australia

Doctors of Ivanhoe,; 🇦🇺 Melbourne, Australia

Lung Institute of Western Australia,; 🇦🇺 Nedlands, Australia

Pitt Street Merrylands Medical Centre; 🇦🇺 Sydney, Australia

Greenhithe Medical Centre; 🇳🇿 Auckland, New Zealand

West Alabama Research, Inc.; 🇺🇸 Birmingham, Alabama, United States

NextCare Institute for Clinical Research; 🇺🇸 Phoenix, Arizona, United States

NEA Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Greystone Medical Research, LLC; 🇺🇸 Birmingham, Alabama, United States

Clopton Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Impact Clinical Trials; 🇺🇸 Beverly Hills, California, United States

North Central Arkansas Medical Associates; 🇺🇸 Mountain Home, Arkansas, United States

Medcenter; 🇺🇸 Carmichael, California, United States

1st Allergy and Clinical Research Center; 🇺🇸 Centennial, Colorado, United States

Alpine Research Center; 🇺🇸 Boulder, Colorado, United States

Center for Clinical Trials, LLC; 🇺🇸 Paramount, California, United States

Coastal Medical Research Group, Inc.; 🇺🇸 San Luis Obispo, California, United States

Clinical Research of South Florida; 🇺🇸 Coral Gables, Florida, United States

Westside Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

DMI Research, Inc.; 🇺🇸 Pinellas Park, Florida, United States

University Clinical Research, Inc.; 🇺🇸 Pembroke Pines, Florida, United States

Wilker/Powers Center for Clinical Studies, d/b/a ProHealth Clinical Studies; 🇺🇸 St. Cloud, Florida, United States

Southeast Regional Research Group; 🇺🇸 Savannah, Georgia, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

The Kaufmann Clinic, Inc.; 🇺🇸 Woodstock, Georgia, United States

Medical Associates Clinic; 🇺🇸 Dubuque, Iowa, United States

Idaho Falls Infectious Diseases; 🇺🇸 Idaho Falls, Idaho, United States

Dr. Arthur Davida; 🇺🇸 Bloomingdale, Illinois, United States

Kentucky Lung Clinic; 🇺🇸 Hazard, Kentucky, United States

Gulf Coast Research, LLC; 🇺🇸 Baton Rouge, Louisiana, United States

Acadia Clinical Research; 🇺🇸 Bangor, Maine, United States

Clarksburg Medical Center; 🇺🇸 Clarksburg, Maryland, United States

Miray Medical Center; 🇺🇸 Brockton, Massachusetts, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Detroit Receiving Hospital, UHC 6G; 🇺🇸 Detroit, Michigan, United States

KMED Research; 🇺🇸 St. Claire Shores, Michigan, United States

Olive Branch Family Medical Center; 🇺🇸 Olive Branch, Mississippi, United States

Impact Clinical Trials, Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Bland Clinic; 🇺🇸 Greensboro, North Carolina, United States

Twelve Corners Internal Medicine; 🇺🇸 Rochester, New York, United States

Prairie Fields Family Medicine, P.C.; 🇺🇸 Fremont, Nebraska, United States

United Medical Associates; 🇺🇸 Johnson City, New York, United States

Advanced Health Care Services, Inc; 🇺🇸 Thornville, Ohio, United States

Community Medical Associates, LLC; 🇺🇸 Canfield, Ohio, United States

Urgent Care of Green County, PLLC; 🇺🇸 Owasso, Oklahoma, United States

Integrated Medical Research, PC; 🇺🇸 Ashland, Oregon, United States

Pivotal Clinical Research, LLC; 🇺🇸 Souderton, Pennsylvania, United States

Notheast Clinical Research; 🇺🇸 Cumberland, Rhode Island, United States

New England Center for Clinical Research, Inc.; 🇺🇸 Cranston, Rhode Island, United States

Clinical Partners, LLC; 🇺🇸 Johnston, Rhode Island, United States

Hillcrest Clinical Research, LLC; 🇺🇸 Simpsonville, South Carolina, United States

DiscoveResearch, Inc.; 🇺🇸 Bryan, Texas, United States

Holston Medical Group; 🇺🇸 Bristol, Tennessee, United States

Health Concepts; 🇺🇸 Rapid City, South Dakota, United States

Corpus Christi Family Wellness Center, Research Division; 🇺🇸 Corpus Christi, Texas, United States

Towngate Plaza Medical Center; 🇺🇸 Garland, Texas, United States

Allergy/Immunology Research Center of North Texas; 🇺🇸 Dallas, Texas, United States

Texas Medical Research Associates, LLC; 🇺🇸 San Antonio, Texas, United States

Martin Diagnostic Clinic; 🇺🇸 Tomball, Texas, United States

J. Lewis Research, Inc., FirstMed; 🇺🇸 Salt Lake City, Utah, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

J. Lewis Research, Inc./FirstMed East; 🇺🇸 Salt Lake City, Utah, United States

Dean Medical Center; 🇺🇸 Oregon, Wisconsin, United States

Pacific Medical Centre Blacktown; 🇦🇺 Blacktown, New South Wales, Australia

East Sydney Doctors; 🇦🇺 Darlinghurst, New South Wales, Australia

Caboolture Clinical Research Centre; 🇦🇺 Caboolture, Queensland, Australia

Peninsula Medical Centre; 🇦🇺 Umina, New South Wales, Australia

Symbion Pathology; 🇦🇺 Hurtsville, New South Wales, Australia

Peninsula Specialist Centre; 🇦🇺 Kpparing, Queensland, Australia

Rivercity Private Hospital Specialist; 🇦🇺 Auchenflower, Queensland, Australia

Dr Doongs Surgery; 🇦🇺 Burwood, Australia

Health Services -University of Melbourne; 🇦🇺 Carlton, Victoria, Australia

Trialworks Clinical Research Services; 🇦🇺 Brisbane, Australia

St George's Hospital; 🇳🇿 Christchurch, New Zealand

Southern Clinical Trials Ltd; 🇳🇿 Christchurch, New Zealand

Nortje, MD; 🇿🇦 Goodwood, Capetown, South Africa

Bairds Road Family Health Care; 🇳🇿 Rotorua, New Zealand

Caversham Medical Centre; 🇳🇿 Dunedin, New Zealand

Dr. Gillies; 🇳🇿 Rotorua, New Zealand

Hinemoa House Family Health Centre; 🇳🇿 Rotorua, New Zealand

Greenbury Medical Centre; 🇿🇦 Greenbury, Durban, South Africa

Sebastian, MD; 🇿🇦 Silverglen, Durban, South Africa

Quinta-Research; 🇿🇦 Bloemfontein, Free State, South Africa

Wilhase, AC; 🇿🇦 Reigerpark, Gauteg, South Africa

NHC Medical Centre; 🇿🇦 Bryanston, Gauteng, South Africa

R. Dulabh, MD; 🇿🇦 Klipspruit West, Gauteng, South Africa

DJW Navorsing; 🇿🇦 Noordheuwel, Krugersdorp, South Africa

Vawda, Z.FA; 🇿🇦 Durban, KZ-Natal, South Africa

Pillay, MD; 🇿🇦 Verulam, Kwa Zulu Natal, South Africa

le Clus, MD; 🇿🇦 Kempton Park, Pretoria, South Africa

Sunnyside Medi-Clinic; 🇿🇦 Sunnyside Pretoria, Pretoria, South Africa

Kaapzicht Centre; 🇿🇦 Cape Town, W. Cape, South Africa

Syzygy SMO Intercare Medical and Dental Centre; 🇿🇦 Cape Town, W. Cape, South Africa

Clinical Project Research SA (Pty) Ltd.; 🇿🇦 Worcester, W. Cape, South Africa

Armansis Medical Centre; 🇿🇦 Brits, South Africa

Benmed Park Clinic; 🇿🇦 Benoni, South Africa

Dr. van Rensburg; 🇿🇦 Amanzimtoti, South Africa

Cape Clinical Trial, Bishop Lavis Day Hospital; 🇿🇦 Cape town, South Africa

Jsha Research; 🇿🇦 Bloemfontein, South Africa

First House; 🇿🇦 Cape Town, South Africa

Synapta Clinical Research Centre; 🇿🇦 Durban, South Africa

Dr. Makan; 🇿🇦 Johannesburg, South Africa

Dr. Janari; 🇿🇦 Durban, South Africa

Newgate Centre; 🇿🇦 Johannesburg, South Africa

GCT Trials, Mercantile Hospital no 9; 🇿🇦 Port Elizabeth, South Africa

Dr. Nel; 🇿🇦 Pretoria, South Africa

Dr. de Bruin; 🇿🇦 Pretoria, South Africa

Westmed Clinical Trial Centre, Pretoria West Medicross Building; 🇿🇦 Pretoria, South Africa

Emmed Research; 🇿🇦 Pretoria, South Africa

Dr. Fouche; 🇿🇦 Roodepoort, South Africa

Dr. Bhorat; 🇿🇦 Soweto, South Africa

Dr. de Villiers; 🇿🇦 Scottburgh, South Africa

Clinical Projects Research SA Ltd; 🇿🇦 Worcester, South Africa

J. Lewis Research, Inc./Foothill Family Clinic South; 🇺🇸 Salt Lake City, Utah, United States

Athelstone Medical Clinic; 🇦🇺 Adelaide, Australia

Omega Medical Research; 🇺🇸 Warwick, Rhode Island, United States

Investigators Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Bozeman Urgent Care Center; 🇺🇸 Bozeman, Montana, United States

Heart of America Research; 🇺🇸 Shawnee, Kansas, United States