Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza

NCT00610935 | Terminated Phase 3 Results DMC

• 2 other identifiers: BCX1812 311HHS # O100200700032C
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 96

Brief Summary

The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza.

Conditions

Influenza

Keywords

Influenza; Subjects with uncomplicated acute influenza

Outcome Measures

Primary Outcomes (1)

• The Time to Alleviation of Clinical Signs and Symptoms of Influenza

  The primary efficacy endpoint was the time to alleviation of symptoms of influenza in subjects diagnosed with influenza, defined as the time from injection of study drug to the start of the time period when a subject had Alleviation of Symptoms. A subject had Alleviation of Symptoms if each of the seven symptoms of influenza (cough, sore throat, nasal obstruction, myalgia \[aches and pains\], headache, feverishness, and fatigue) as self-assessed and recorded in the subject diary were either absent or were present at no more than mild severity level and at this status for at least 21.5 hours (24 hours minus 10%). No statistical testing was performed.

  Up to 14 days

Secondary Outcomes (1)

• To Evaluate Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.

  Change from baseline assessed on days 3, 5 and 9.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo intramuscular injection

Drug: Placebo

Peramivir

EXPERIMENTAL

Single intramuscular injection of 300mg peramivir

Drug: Peramivir

Interventions

Peramivir DRUG

To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.

Peramivir

Placebo DRUG

Single intramuscular injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and non-pregnant female subjects age ≥18 years.
• A positive Influenza A and/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 48 hours before presentation for screening.
• Written informed consent.

You may not qualify if:

• 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 (See section 15.2).
• History of congestive heart failure 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.

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (96)

Physical Express

Millbrook, Alabama, 36054, United States

Location

Alabama Family Medical Center

Tuscaloosa, Alabama, 35404, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Clopton Clinic

Jonesboro, Arkansas, 72401, United States

Location

Research Solutions, LLC

Jonesboro, Arkansas, 72401, United States

Location

Kevin Adkins, MD

Mountain Home, Arkansas, 72653, United States

Location

NuLife Clinical Research, Inc.

Anaheim, California, 92805, United States

Location

Impact Clinical Trials

Beverly Hills, California, 90211, United States

Location

Associated Pharmaceutical Research Center, Inc.

Buena Park, California, 90620, United States

Location

Med Investigations Incorporated

Fair Oaks, California, 95628, United States

Location

Universal Biopharma Research Institute Inc.

Fresno, California, 93703, United States

Location

Research Center of Fresno, Inc

Fresno, California, 93726, United States

Location

Harmony Clinical, Inc.

Garden Grove, California, 92843, United States

Location

Allergy, Asthma, and Respiratory Care Medical Center

Long Beach, California, 90806, United States

Location

National Institute of Clinical Research

Los Angeles, California, 90017, United States

Location

Center for Clinical Trials, LLC

Paramount, California, 90723, United States

Location

San Diego Sports Medicine and Family Health Center

San Diego, California, 92120, United States

Location

Coastal Medical Research Group, Inc.

San Luis Obispo, California, 93405, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80304, United States

Location

Clinicos, LLC

Colorado Springs, Colorado, 80904, United States

Location

Longmont Clinic, P.C.

Longmont, Colorado, 80501, United States

Location

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

AGA Clinical Trials

Hialeah, Florida, 33012, United States

Location

Eastern Research

Hialeah, Florida, 33013, United States

Location

Century Clinical Research Inc

Holly Hill, Florida, 32117, 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

Office of Roger J. Miller, Jr., MD

Jacksonville, Florida, 32257, United States

Location

MD Now Medical Center

Lake Worth, Florida, 33463, United States

Location

DMI Healthcare Group

Largo, Florida, 33773, United States

Location

Well Pharma Medical Research, Corp.

Miami, Florida, 33143, United States

Location

Compass Research LLC

Orlando, Florida, 32806, United States

Location

Pines Research, LLC

Pembroke Pines, Florida, 33028, United States

Location

Wilker/Powers Center for Clinical Studies

Saint Cloud, Florida, 34769, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Sandersville Family Practice Center

Sandersville, Georgia, 31082, United States

Location

Quincy Medical Group

Quincy, Illinois, 62301, United States

Location

Investigators Research Group, LLC

Indianapolis, Indiana, 46268, United States

Location

Welborn Clinic Gateway

Newburgh, Indiana, 47630, United States

Location

Medical Associates Clinic PC

Dubuque, Iowa, 52001, United States

Location

Heart of America Research Institute

Shawnee Mission, Kansas, 66216, United States

Location

American Medical Exams, P.A.

Topeka, Kansas, 66608, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67212, United States

Location

Kentucky Lung Clinic

Hazard, Kentucky, 41701, United States

Location

Winchester, Patton, Burgess, PSC

Whitley City, Kentucky, 42653-0099, United States

Location

Gulf Coast Research, LLC

Baton Rouge, Louisiana, 70808, United States

Location

Gulf Coast Research LLC

Lafayette, Louisiana, 70503, United States

Location

Byron Jackson

Shreveport, Louisiana, 71104, United States

Location

Professional Clinical Research-Benzonia

Benzonia, Michigan, 49616, United States

Location

Professional Clinical Research, Inc.

Cadillac, Michigan, 49601, United States

Location

Professional Clinical Research-Interlochen

Interlochen, Michigan, 49643, United States

Location

KMED Research

Saint Clair Shores, Michigan, 48081, United States

Location

Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

Clinvest

Springfield, Missouri, 65807, United States

Location

Clinical Research Department

Bozeman, Montana, 59715, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Prarie Fields Family Medicine, P.C

Fremont, Nebraska, 68025, United States

Location

Quick Care Medical

Hamilton, New Jersey, 08690, United States

Location

Health Sciences Research Center at Asthma & Allergy Associates P.C.

Elmira, New York, 14901, United States

Location

Health Sciences Research Center

Ithaca, New York, 14850, United States

Location

American Institute of Healthcare & Fitness

Raleigh, North Carolina, 27605, United States

Location

Community Medical Partners

Canfield, Ohio, 44406, United States

Location

Parsons Avenue Medical Clinic

Columbus, Ohio, 43207, United States

Location

Ohio Clinical Research LLC

Lyndhurst, Ohio, 44124, United States

Location

Physician Care PM

Edmond, Oklahoma, 73013, United States

Location

Urgent Care of Green County

Owasso, Oklahoma, 74055, United States

Location

Integrated Medical Research PC

Ashland, Oregon, 97520, United States

Location

Primary Physicians Research Inc.

Pittsburgh, Pennsylvania, 15241, United States

Location

Warminster Medical Associates, PC

Warminster, Pennsylvania, 18974, United States

Location

New England Center for Clinical Research, Inc.

Cranston, Rhode Island, 02920, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Paris View Family Practice

Greenville, South Carolina, 29601, United States

Location

Andras Koser

Greenville, South Carolina, 29615, United States

Location

Hillcrest Clinical Research, LLC

Simpsonville, South Carolina, 29681, United States

Location

S. Carolina Pharmaceutical Research

Spartanburg, South Carolina, 29303, United States

Location

Holston Medical Group, PC

Bristol, Tennessee, 37620, United States

Location

Holston Medical Group, P.C.

Kingsport, Tennessee, 37660, United States

Location

DiscoveResearch Inc.

Beaumont, Texas, 77701, United States

Location

DiscoveResearch, Inc.

Bryan, Texas, 77802, United States

Location

Intrinsic Research Data, Inc.

Corpus Christi, Texas, 78411, United States

Location

Allergy/Immunology Research Center of North Texas

Dallas, Texas, 75230, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

West Houston Clinical Research Service

Houston, Texas, 77055, United States

Location

Dynamed Clinical Research, L.P.

Houston, Texas, 77070, United States

Location

Sun Research Institute

San Antonio, Texas, 78205, United States

Location

GSA Research

San Antonio, Texas, 78213, United States

Location

San Antonio Preventive and Diagnostic Medicine

San Antonio, Texas, 78229, United States

Location

Optimum Clinical Research

Salt Lake City, Utah, 84102, United States

Location

J. Lewis Research Inc

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.

Salt Lake City, Utah, 84121, United States

Location

Physicians Research Options, LLC

Saratoga Springs, Utah, 84045, United States

Location

J. Lewis Research Inc. FirstMed

West Jordan, Utah, 84088, United States

Location

Virginia Adult & Pediatric Allergy & Asthma, P.C Department of Clinical Research

Richmond, Virginia, 23229, United States

Location

Holston Medical Group

Weber City, Virginia, 24290, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

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

Limitations and Caveats

The study was terminated at the discretion of the Sponsor after 82 of the planned 600 subjects were enrolled. The reason for study termination was to allow the Sponsor to focus development efforts on a more concentrated formulation which would also allow evaluation of higher doses of peramivir administered intramuscularly.

Results Point of Contact

• Title: Study Director
• Organization: BioCryst Pharmaceuticals Inc

clinicaltrials@biocryst.com

+1 919-859-1302

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 8, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 17, 2021
• Results First Posted: March 17, 2021

Record last verified: 2021-02

Locations

US (96)