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

NCT00419263 | Completed Phase 2 Results DMC

• 1 other identifier: BCX1812-211
• Study Type: interventional
• Target: 344
• Locations: 2 countries
• Sites: 69

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.

Conditions

Influenza

Keywords

influenza; flu

Outcome Measures

Primary Outcomes (1)

• Time to Alleviation of Symptoms (Kaplan-Meier Estimate)

  Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed.

  Up to 14 days

Secondary Outcomes (6)

• Time to Resolution of Fever

  Up to 14 days

• Time to Resumption of Ability to Perform Usual Activities

  Up to 14 days

• Change From Baseline to Day 2 in Influenza Virus Titer

  Baseline and approximately 24 hours after treatment

• Change From Baseline to Day 3 in Influenza Virus Titer

  Baseline and approximately 48 hours after treatment

• Change From Baseline to Day 5 in Influenza Virus Titer

  Baseline and approximately 96 hours after treatment

Study Arms (3)

Peramivir 150 mg

EXPERIMENTAL

Drug: Peramivir 150 mg

Peramivir 300 mg

EXPERIMENTAL

Drug: Peramivir 300 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Peramivir 150 mg 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).

Also known as: BCX1812

Peramivir 150 mg

Peramivir 300 mg DRUG

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

Also known as: BCX1812

Peramivir 300 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (69)

Radiant Research

Birmingham, Alabama, 35209, United States

Location

Clopton Clinic

Jonesboro, Arkansas, 72401, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Orange County Clinical Trials

Anaheim, California, 92801, United States

Location

Medical Center

Carmichael, California, 95608, United States

Location

Pacific Sleep Medicines Service

El Centro, California, 92243, United States

Location

Advanced Clinical Research Institute

Orange, California, 92869, United States

Location

Benchmark Research

Sacramento, California, 95816, United States

Location

Pacific Sleep Medicine Services

San Diego, California, 92121, United States

Location

Pacific Sleep Medicine Services

San Francisco, California, 94105, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80304, United States

Location

George Washington Unviersity

Washington D.C., District of Columbia, 20037, United States

Location

Clinical Research of Southern Florida

Coral Gables, Florida, 33134, United States

Location

University Clinical Research-Deland, LLC

DeLand, Florida, 32720, United States

Location

Florida Medical Research Institute

Gainesville, Florida, 32607, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Clinical Research Center

Sarasota, Florida, 34239, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Georgia Clinical Research

Atlanta, Georgia, 30308, United States

Location

Wishard Hospital

Indianapolis, Indiana, 46202, United States

Location

Radiant Research

Overland Park, Kansas, 66215, United States

Location

Kentucky Pediatric / Adult Research

Bardstown, Kentucky, 40004, United States

Location

Central Kentucky Research Assoc, Inc

Lexington, Kentucky, 40509, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Radiant Research, Minneapolis

Edina, Minnesota, 55435, United States

Location

Barnes-Jewish Hospital Emergency Department

St Louis, Missouri, 63110, United States

Location

Medex Healthcare Research, Inc.

St Louis, Missouri, 63124, United States

Location

Radiant Research

St Louis, Missouri, 63141, United States

Location

Bozeman Urgent Care Center

Bozeman, Montana, 59715, United States

Location

Alliance Medical Center

Alliance, Nebraska, 69301, United States

Location

Midwest Family Physicians

Omaha, Nebraska, 68154, United States

Location

UMDNJ

Cherry Hill, New Jersey, 08002, United States

Location

Pulmonary & Critical Care Associates

East Brunswick, New Jersey, 08816, United States

Location

Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Summa Health

Akron, Ohio, 44304, United States

Location

Sterling Research Group, LTD.

Cincinnati, Ohio, 45219, United States

Location

Integrated Medical Research, PC

Ashland, Oregon, 97520, United States

Location

Research Across America at Oyster Point Family Health Center

Lancaster, Pennsylvania, 17601, United States

Location

Radiant Research

Philadelphia, Pennsylvania, 19115, United States

Location

Primary Physicians Research, Inc

Pittsburgh, Pennsylvania, 15241, United States

Location

New England Center for Clinical Research, Inc

Cranston, Rhode Island, 02920, United States

Location

Paragon Clinical Research, Inc.

Cranston, Rhode Island, 02920, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Hillcrest Family Practice

Simpsonville, South Carolina, 29681, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Radiant Research

Dallas, Texas, 75235, United States

Location

Towngate Plaza Medical Center

Garland, Texas, 75041, United States

Location

Baylor Clinic-Baylor College of Medicine

Houston, Texas, 77030, United States

Location

GSA Research

San Antonio, Texas, 78213, United States

Location

Radiant Research-San Antonio Northeast

San Antonio, Texas, 78217, United States

Location

Radiant Research San Antonio

San Antonio, Texas, 78229, United States

Location

Balbir Chahal M.D. ,P.A

Tomball, Texas, 77375, United States

Location

Dynamed Clinical Research

Tomball, Texas, 77375, United States

Location

J. Lewis Research, Inc. Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

J. Lewis Research, Inc./Southwest Family Medicine

West Jordan, Utah, 84084, United States

Location

Calgary West Medical Cnetre Clinical Studies

Calgary, Alberta, T3C3P1, Canada

Location

Belvedere Medicentre

Edmonton, Alberta, T5COA3, Canada

Location

Hermitage Medicentres

Edmonton, Alberta, T5COA3, Canada

Location

RJA Medicentres

Edmonton, Alberta, T5N2N8, Canada

Location

Castledowns Medicentre

Edmonton, Alberta, T5X3N5, Canada

Location

Gain Medical Centre

Coquitlam, British Columbia, V3K 3P4, Canada

Location

Source Unique Clinic

Hawkesbury, Ontario, K6A1A1, Canada

Location

Manna Research

Toronto, Ontario, M9W4L6, Canada

Location

Omnispec Clinical Reasearch Inc

Mirabel, Quebec, J7J 2K8, Canada

Location

Clinique Medicale des Campus

Ste-Foy, Quebec, G1V4P9, Canada

Location

Prairie Clinical

Saskatoon, Saskatchewan, S7H 5M3, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

peramivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: William P. Sheridan, MBBS
• Organization: BioCryst Pharmaceuticals, Inc.

(919) 859-1302

Study Officials

• Stanley Block, MD

  Kentucky Pediatric/Adult Research

  PRINCIPAL INVESTIGATOR

• James Borders, MD

  Central Kentucky Research Assoc, Inc

  PRINCIPAL INVESTIGATOR

• Robert Broker, MD

  Hillcrest Family Practice

  PRINCIPAL INVESTIGATOR

• Paul Browstone, MD

  Alpine Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Jeffry Jacqmein, MD

  Jacksonville Center For Clinical Research

  PRINCIPAL INVESTIGATOR

• Isaac Marcadis, MD

  Palm Beach Research Center

  PRINCIPAL INVESTIGATOR

• Mark Stich, MD

  Jacksonville Center For Clinical Research

  PRINCIPAL INVESTIGATOR

• George Atiee, MD

  GSA Research

  PRINCIPAL INVESTIGATOR

• Joe Blumenau, MD

  Research Across America

  PRINCIPAL INVESTIGATOR

• John Champlin, MD

  Medical Center

  PRINCIPAL INVESTIGATOR

• Shane Christensen, MD

  J. Lewis Research, Inc. Foothill Family Clinic South

  PRINCIPAL INVESTIGATOR

• Steven Duckor, MD

  Advanced Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Lewis Eirinberg, MD

  Midwest Family Physicians

  PRINCIPAL INVESTIGATOR

• Milton K. Erman, MD

  Pacific Sleep Medicine Services

  PRINCIPAL INVESTIGATOR

• Stanley Cohen, MD

  Radiant Research

  PRINCIPAL INVESTIGATOR

• David L. Fried, MD

  Omega Medical Research

  PRINCIPAL INVESTIGATOR

• Yury Furman, MD

  Pacific Sleep Medicine Services, Inc.

  PRINCIPAL INVESTIGATOR

• Wayne Harper, MD

  Wake Research Associates, LLC

  PRINCIPAL INVESTIGATOR

• Dan C Henry, MD

  J. Lewis Research, Inc. Foothill Family Clinic

  PRINCIPAL INVESTIGATOR

• John M. Hill, MD

  University Clinical Research-Deland, LLC

  PRINCIPAL INVESTIGATOR

• Veryl Hodges, DO

  Clopton Clinic

  PRINCIPAL INVESTIGATOR

• Reuben Holland, III, MD

  Clinical Research Center

  PRINCIPAL INVESTIGATOR

• William Jennings, MD

  Radiant Research San Antonio

  PRINCIPAL INVESTIGATOR

• James Edmond Kelaher, MD,MPH

  Baylor Clinic-Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Allan Kelly, MD

  Hermitage Medicentres

  PRINCIPAL INVESTIGATOR

• Ben Lasko, MD

  Manna Research

  PRINCIPAL INVESTIGATOR

• Mark Leber, MD

  The Brooklyn Hospital Center

  PRINCIPAL INVESTIGATOR

• Larissa Lim, MD

  Florida Medical Research Institute

  PRINCIPAL INVESTIGATOR

• Alain Martel, MD

  Clinique medicale des Campus

  PRINCIPAL INVESTIGATOR

• Dennis Mikolich, MD

  Paragon Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

• Julie Mullen, MD

  Sterling Research Group, LTD.

  PRINCIPAL INVESTIGATOR

• David Parenti, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

• Monica Pierson, MD

  Radiant Research

  PRINCIPAL INVESTIGATOR

• Robert Poirier, MD

  Barnes-Jewish Hospital Emergency Department

  PRINCIPAL INVESTIGATOR

• Ivan Rarick, MD

  Benchmark Research

  PRINCIPAL INVESTIGATOR

• Dennis Riff, MD

  Advanced Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Q Rizvi, MD

  Castledowns Medicentre

  PRINCIPAL INVESTIGATOR

• Michael Rokeach, MD

  Pacific Sleep Medicine Services

  PRINCIPAL INVESTIGATOR

• Rawle Seupaul, MD

  Wishard Hospital

  PRINCIPAL INVESTIGATOR

• Daniel Shu, MD

  Gain Medical Research Centre

  PRINCIPAL INVESTIGATOR

• Steve Sitar, MD

  Orange County Clinical Trials

  PRINCIPAL INVESTIGATOR

• Kirk Stiffler, MD

  Summa Emergency Associates Inc.

  PRINCIPAL INVESTIGATOR

• Guy Tellier, MD

  Omnispec clinical research Inc

  PRINCIPAL INVESTIGATOR

• Michael Warren, MD

  Research Across America at Oyster Point Family Health Center

  PRINCIPAL INVESTIGATOR

• Randall Watson, MD

  J. Lewis Research, Inc./Southwest Family Medicine

  PRINCIPAL INVESTIGATOR

• John Michael Wise, MD

  Bozeman Urgent Care Center

  PRINCIPAL INVESTIGATOR

• Chivers Woodruff, Jr., MD

  Radiant Research

  PRINCIPAL INVESTIGATOR

• Bruce Berwald, MD

  Radiant Research

  PRINCIPAL INVESTIGATOR

• Frank Maggiacomo, DO

  New England Center for Clinical Research, Inc

  PRINCIPAL INVESTIGATOR

• Barry Packman, MD

  Radiant Research

  PRINCIPAL INVESTIGATOR

• Sheila Rodstein, MD

  Radiant Research, Minneapolis

  PRINCIPAL INVESTIGATOR

• Bernardo Ng, MD

  Pacific Sleep Medicines Service

  PRINCIPAL INVESTIGATOR

• Gerardo Losoya, MD

  Towngate Plaza Medical Center

  PRINCIPAL INVESTIGATOR

• Francis X. Burch, MD

  Radiant Research-San Antonio Northeast

  PRINCIPAL INVESTIGATOR

• John P. Delgado, MD

  Integrated Medical Research, PC

  PRINCIPAL INVESTIGATOR

• Edward Fein, MD

  Pulmonary & Critical Care Associates

  PRINCIPAL INVESTIGATOR

• Bruce D. Forney, MD

  Alliance Medical Center

  PRINCIPAL INVESTIGATOR

• James E. Greenwald, MD

  Medex Healthcare Research, Inc.

  PRINCIPAL INVESTIGATOR

• Robert Hudrick, DO

  University of Medicine & Dentistry of New Jersey

  PRINCIPAL INVESTIGATOR

• Robert Jeanfreau, MD

  Benchmark Research

  PRINCIPAL INVESTIGATOR

• Robert Kaufmann, MD

  Georgia Clinical Research

  PRINCIPAL INVESTIGATOR

• Sy Lam, MD

  Calgary West Medical Centre Clinical Studies

  PRINCIPAL INVESTIGATOR

• Keith S. Reisinger, MD, MPH

  Primary Physicians Research, Inc

  PRINCIPAL INVESTIGATOR

• Keith S. Reisinger, MD, MPH

  Family Practice Medical Associates South

  PRINCIPAL INVESTIGATOR

• Earl Martin, MD

  Dynamed Clinical Research

  PRINCIPAL INVESTIGATOR

• Jean-Sebastien Gauthier, MD

  Q & T Research Inc.

  PRINCIPAL INVESTIGATOR

• Jeffrey Rosen, MD

  Clinical Research of Southern Florida

  PRINCIPAL INVESTIGATOR

• Gerald Burns, MD

  New Orleans Medical

  PRINCIPAL INVESTIGATOR

• Stewart Behiel, MD

  Belvedere Medicentre

  PRINCIPAL INVESTIGATOR

• Giuseppe D'Ignazio, MD

  Source Unique Clinic

  PRINCIPAL INVESTIGATOR

• Indravadan Dattani, MD

  Prairie Clinical

  PRINCIPAL INVESTIGATOR

• Roy A. Gritter, MD

  RJA Medicentres

  PRINCIPAL INVESTIGATOR

• Balbir Chahal, MD

  Balbir Chahal M.D. ,P.A.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2007
• First Posted: January 8, 2007
• Study Start: January 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: February 12, 2015
• Results First Posted: February 12, 2015

Record last verified: 2015-01

Locations

CA (11); US (58)