Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.

NCT ID: NCT00419263

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-09-30

Brief Summary

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.

Detailed Description

Peramivir is a neuraminidase inhibitor that was previously shown to be effective in the treatment of human experimental influenza using an oral formulation. Parenteral formulations of peramivir (for intramuscular and intravenous injection) entered clinical development at the time of this Phase 2 study. A series of Phase 1 studies in human volunteers was completed that provided safety and pharmacokinetic results that supported the initiation of this Phase 2 multinational, randomized, double-mask study that compared the antiviral efficacy and safety of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza. Because of the unique pharmacokinetic and pharmacodynamic properties of peramivir - a long terminal half life in plasma and an extended duration of binding to the neuraminidase enzyme - subjects were randomized in a 1:1:1 ratio to receive a single dose of one of three treatments: peramivir 150 mg, peramivir 300 mg, and placebo. Study drug was administered as one 2-mL intramuscular injection in each gluteal muscle (total of 4 mL, injected in divided doses). This multinational study was originally to be conducted at approximately 80 sites in the US and Canada. When enrollment during the North American influenza season of 2006-2007 did not achieve the target, the study was extended to sites in Australia, New Zealand, South Africa, and Hong Kong.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Peramivir 150 mg

Group Type: EXPERIMENTAL

Peramivir 150 mg

Intervention Type: DRUG

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).

Peramivir 300 mg

Group Type: EXPERIMENTAL

Peramivir 300 mg

Intervention Type: DRUG

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).

Interventions

Peramivir 150 mg

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).

Intervention Type: DRUG

Peramivir 300 mg

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).

Intervention Type: DRUG

Placebo

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).

Intervention Type: DRUG

Other Intervention Names

BCX1812; BCX1812

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• 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 the subject has a history of fever within the 24 hours prior to screening and has been administered antipyretic(s) in the 6 hours prior to screening.
• Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)
• Presence of at least one constitutional symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) of any severity (mild, moderate, or severe)
• 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.
• Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal 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.
• 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.

Exclusion Criteria

• Women who are breast-feeding
• History of diagnosed chronic obstructive pulmonary disease or diagnosis of severe persistent asthma
• 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)
• 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
• Immunocompromised status due to illness or previous organ transplant
• Current use of systemic immunosuppressive medications (except inhaled corticosteroids)
• Use of rimantadine, amantadine, zanamivir, or oseltamivir in the past 7 days
• Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days
• Clinical evidence of active bacterial infection at any body site requiring therapy with oral or systemic antibiotics
• Clinically significant signs of acute respiratory distress
• Clinically significant signs of acute cardiac disease
• Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia
• 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)
• History of hepatitis B, hepatitis C, or human immunodeficiency virus infection
• History of alcohol abuse or drug addiction within 1 year prior to admission in the study
• Participation in a study of any investigational drug within the last 30 days
• Positive urine pregnancy test

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanley Block, MD

Role: PRINCIPAL_INVESTIGATOR

Kentucky Pediatric/Adult Research

James Borders, MD

Role: PRINCIPAL_INVESTIGATOR

Central Kentucky Research Assoc, Inc

Robert Broker, MD

Role: PRINCIPAL_INVESTIGATOR

Hillcrest Family Practice

Paul Browstone, MD

Role: PRINCIPAL_INVESTIGATOR

Alpine Clinical Research Center

Jeffry Jacqmein, MD

Role: PRINCIPAL_INVESTIGATOR

Jacksonville Center For Clinical Research

Isaac Marcadis, MD

Role: PRINCIPAL_INVESTIGATOR

Palm Beach Research Center

Mark Stich, MD

Role: PRINCIPAL_INVESTIGATOR

Jacksonville Center For Clinical Research

George Atiee, MD

Role: PRINCIPAL_INVESTIGATOR

GSA Research

Joe Blumenau, MD

Role: PRINCIPAL_INVESTIGATOR

Research Across America

John Champlin, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center

Shane Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

J. Lewis Research, Inc. Foothill Family Clinic South

Steven Duckor, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Clinical Research Institute

Lewis Eirinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Family Physicians

Milton K. Erman, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Sleep Medicine Services

Stanley Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research

David L. Fried, MD

Role: PRINCIPAL_INVESTIGATOR

Omega Medical Research

Yury Furman, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Sleep Medicine Services, Inc.

Wayne Harper, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Research Associates, LLC

Dan C Henry, MD

Role: PRINCIPAL_INVESTIGATOR

J. Lewis Research, Inc. Foothill Family Clinic

John M. Hill, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinical Research-Deland, LLC

Veryl Hodges, DO

Role: PRINCIPAL_INVESTIGATOR

Clopton Clinic

Reuben Holland, III, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center

William Jennings, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research San Antonio

James Edmond Kelaher, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Baylor Clinic-Baylor College of Medicine

Allan Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Hermitage Medicentres

Ben Lasko, MD

Role: PRINCIPAL_INVESTIGATOR

Manna Research

Mark Leber, MD

Role: PRINCIPAL_INVESTIGATOR

The Brooklyn Hospital Center

Larissa Lim, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Medical Research Institute

Alain Martel, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique medicale des Campus

Dennis Mikolich, MD

Role: PRINCIPAL_INVESTIGATOR

Paragon Clinical Research, Inc.

Julie Mullen, MD

Role: PRINCIPAL_INVESTIGATOR

Sterling Research Group, LTD.

David Parenti, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Monica Pierson, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research

Robert Poirier, MD

Role: PRINCIPAL_INVESTIGATOR

Barnes-Jewish Hospital Emergency Department

Ivan Rarick, MD

Role: PRINCIPAL_INVESTIGATOR

Benchmark Research

Dennis Riff, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Clinical Research Institute

Q Rizvi, MD

Role: PRINCIPAL_INVESTIGATOR

Castledowns Medicentre

Michael Rokeach, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Sleep Medicine Services

Rawle Seupaul, MD

Role: PRINCIPAL_INVESTIGATOR

Wishard Hospital

Daniel Shu, MD

Role: PRINCIPAL_INVESTIGATOR

Gain Medical Research Centre

Steve Sitar, MD

Role: PRINCIPAL_INVESTIGATOR

Orange County Clinical Trials

Kirk Stiffler, MD

Role: PRINCIPAL_INVESTIGATOR

Summa Emergency Associates Inc.

Guy Tellier, MD

Role: PRINCIPAL_INVESTIGATOR

Omnispec clinical research Inc

Michael Warren, MD

Role: PRINCIPAL_INVESTIGATOR

Research Across America at Oyster Point Family Health Center

Randall Watson, MD

Role: PRINCIPAL_INVESTIGATOR

J. Lewis Research, Inc./Southwest Family Medicine

John Michael Wise, MD

Role: PRINCIPAL_INVESTIGATOR

Bozeman Urgent Care Center

Chivers Woodruff, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research

Bruce Berwald, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research

Frank Maggiacomo, DO

Role: PRINCIPAL_INVESTIGATOR

New England Center for Clinical Research, Inc

Barry Packman, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research

Sheila Rodstein, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research, Minneapolis

Bernardo Ng, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Sleep Medicines Service

Gerardo Losoya, MD

Role: PRINCIPAL_INVESTIGATOR

Towngate Plaza Medical Center

Francis X. Burch, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research-San Antonio Northeast

John P. Delgado, MD

Role: PRINCIPAL_INVESTIGATOR

Integrated Medical Research, PC

Edward Fein, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary & Critical Care Associates

Bruce D. Forney, MD

Role: PRINCIPAL_INVESTIGATOR

Alliance Medical Center

James E. Greenwald, MD

Role: PRINCIPAL_INVESTIGATOR

Medex Healthcare Research, Inc.

Robert Hudrick, DO

Role: PRINCIPAL_INVESTIGATOR

University of Medicine & Dentistry of New Jersey

Robert Jeanfreau, MD

Role: PRINCIPAL_INVESTIGATOR

Benchmark Research

Robert Kaufmann, MD

Role: PRINCIPAL_INVESTIGATOR

Georgia Clinical Research

Sy Lam, MD

Role: PRINCIPAL_INVESTIGATOR

Calgary West Medical Centre Clinical Studies

Keith S. Reisinger, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Primary Physicians Research, Inc

Keith S. Reisinger, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Family Practice Medical Associates South

Earl Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Dynamed Clinical Research

Jean-Sebastien Gauthier, MD

Role: PRINCIPAL_INVESTIGATOR

Q & T Research Inc.

Jeffrey Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research of Southern Florida

Gerald Burns, MD

Role: PRINCIPAL_INVESTIGATOR

New Orleans Medical

Stewart Behiel, MD

Role: PRINCIPAL_INVESTIGATOR

Belvedere Medicentre

Giuseppe D'Ignazio, MD

Role: PRINCIPAL_INVESTIGATOR

Source Unique Clinic

Indravadan Dattani, MD

Role: PRINCIPAL_INVESTIGATOR

Prairie Clinical

Roy A. Gritter, MD

Role: PRINCIPAL_INVESTIGATOR

RJA Medicentres

Balbir Chahal, MD

Role: PRINCIPAL_INVESTIGATOR

Balbir Chahal M.D. ,P.A.

Locations

Radiant Research

Birmingham, Alabama, United States

Clopton Clinic

Jonesboro, Arkansas, United States

Advanced Clinical Research Institute

Anaheim, California, United States

Orange County Clinical Trials

Anaheim, California, United States

Medical Center

Carmichael, California, United States

Pacific Sleep Medicines Service

El Centro, California, United States

Advanced Clinical Research Institute

Orange, California, United States

Benchmark Research

Sacramento, California, United States

Pacific Sleep Medicine Services

San Diego, California, United States

Pacific Sleep Medicine Services

San Francisco, California, United States

Alpine Clinical Research Center

Boulder, Colorado, United States

George Washington Unviersity

Washington D.C., District of Columbia, United States

Clinical Research of Southern Florida

Coral Gables, Florida, United States

University Clinical Research-Deland, LLC

DeLand, Florida, United States

Florida Medical Research Institute

Gainesville, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Clinical Research Center

Sarasota, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Georgia Clinical Research

Atlanta, Georgia, United States

Wishard Hospital

Indianapolis, Indiana, United States

Radiant Research

Overland Park, Kansas, United States

Kentucky Pediatric / Adult Research

Bardstown, Kentucky, United States

Central Kentucky Research Assoc, Inc

Lexington, Kentucky, United States

Benchmark Research

Metairie, Louisiana, United States

Radiant Research, Minneapolis

Edina, Minnesota, United States

Barnes-Jewish Hospital Emergency Department

St Louis, Missouri, United States

Medex Healthcare Research, Inc.

St Louis, Missouri, United States

Radiant Research

St Louis, Missouri, United States

Bozeman Urgent Care Center

Bozeman, Montana, United States

Alliance Medical Center

Alliance, Nebraska, United States

Midwest Family Physicians

Omaha, Nebraska, United States

UMDNJ

Cherry Hill, New Jersey, United States

Pulmonary & Critical Care Associates

East Brunswick, New Jersey, United States

Brooklyn Hospital Center

Brooklyn, New York, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Summa Health

Akron, Ohio, United States

Sterling Research Group, LTD.

Cincinnati, Ohio, United States

Integrated Medical Research, PC

Ashland, Oregon, United States

Research Across America at Oyster Point Family Health Center

Lancaster, Pennsylvania, United States

Radiant Research

Philadelphia, Pennsylvania, United States

Primary Physicians Research, Inc

Pittsburgh, Pennsylvania, United States

New England Center for Clinical Research, Inc

Cranston, Rhode Island, United States

Paragon Clinical Research, Inc.

Cranston, Rhode Island, United States

Omega Medical Research

Warwick, Rhode Island, United States

Hillcrest Family Practice

Simpsonville, South Carolina, United States

Research Across America

Dallas, Texas, United States

Radiant Research

Dallas, Texas, United States

Towngate Plaza Medical Center

Garland, Texas, United States

Baylor Clinic-Baylor College of Medicine

Houston, Texas, United States

GSA Research

San Antonio, Texas, United States

Radiant Research-San Antonio Northeast

San Antonio, Texas, United States

Radiant Research San Antonio

San Antonio, Texas, United States

Balbir Chahal M.D. ,P.A

Tomball, Texas, United States

Dynamed Clinical Research

Tomball, Texas, United States

J. Lewis Research, Inc. Foothill Family Clinic

Salt Lake City, Utah, United States

J. Lewis Research, Inc. Foothill Family Clinic South

Salt Lake City, Utah, United States

J. Lewis Research, Inc./Southwest Family Medicine

West Jordan, Utah, United States

Calgary West Medical Cnetre Clinical Studies

Calgary, Alberta, Canada

Belvedere Medicentre

Edmonton, Alberta, Canada

Hermitage Medicentres

Edmonton, Alberta, Canada

RJA Medicentres

Edmonton, Alberta, Canada

Castledowns Medicentre

Edmonton, Alberta, Canada

Gain Medical Centre

Coquitlam, British Columbia, Canada

Source Unique Clinic

Hawkesbury, Ontario, Canada

Manna Research

Toronto, Ontario, Canada

Omnispec Clinical Reasearch Inc

Mirabel, Quebec, Canada

Clinique Medicale des Campus

Ste-Foy, Quebec, Canada

Prairie Clinical

Saskatoon, Saskatchewan, Canada

Countries

United States; Canada

Other Identifiers

BCX1812-211

Identifier Type: -

Identifier Source: org_study_id