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InfluenzaPhase 2NCT00419263

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

A Phase 2 study testing Peramivir 150 mg and Peramivir 300 mg in people with Influenza, run by BioCryst Pharmaceuticals at 69 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza
What is being tested?
Peramivir 150 mg and Peramivir 300 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
344 participants
Where
69 sitesin 2 countries
Study dates
Jan 2007to Sep 2007
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

69 sites in 2 countries.

69 sites in 2 countries

United States58 sites

  • Summa Health

    Akron, Ohio, 44304

  • Alliance Medical Center

    Alliance, Nebraska, 69301

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Orange County Clinical Trials

    Anaheim, California, 92801

  • Integrated Medical Research, PC

    Ashland, Oregon, 97520

  • Georgia Clinical Research

    Atlanta, Georgia, 30308

  • Kentucky Pediatric / Adult Research

    Bardstown, Kentucky, 40004

  • Radiant Research

    Birmingham, Alabama, 35209

  • Alpine Clinical Research Center

    Boulder, Colorado, 80304

  • Bozeman Urgent Care Center

    Bozeman, Montana, 59715

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201

  • Medical Center

    Carmichael, California, 95608

  • UMDNJ

    Cherry Hill, New Jersey, 08002

  • Sterling Research Group, LTD.

    Cincinnati, Ohio, 45219

  • Clinical Research of Southern Florida

    Coral Gables, Florida, 33134

  • New England Center for Clinical Research, Inc

    Cranston, Rhode Island, 02920

  • Paragon Clinical Research, Inc.

    Cranston, Rhode Island, 02920

  • Research Across America

    Dallas, Texas, 75234

  • Radiant Research

    Dallas, Texas, 75235

  • University Clinical Research-Deland, LLC

    DeLand, Florida, 32720

  • Pulmonary & Critical Care Associates

    East Brunswick, New Jersey, 08816

  • Radiant Research, Minneapolis

    Edina, Minnesota, 55435

  • Pacific Sleep Medicines Service

    El Centro, California, 92243

  • Florida Medical Research Institute

    Gainesville, Florida, 32607

  • Towngate Plaza Medical Center

    Garland, Texas, 75041

  • Baylor Clinic-Baylor College of Medicine

    Houston, Texas, 77030

  • Wishard Hospital

    Indianapolis, Indiana, 46202

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32205

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • Research Across America at Oyster Point Family Health Center

    Lancaster, Pennsylvania, 17601

  • Central Kentucky Research Assoc, Inc

    Lexington, Kentucky, 40509

  • Benchmark Research

    Metairie, Louisiana, 70006

  • Midwest Family Physicians

    Omaha, Nebraska, 68154

  • Advanced Clinical Research Institute

    Orange, California, 92869

  • Radiant Research

    Overland Park, Kansas, 66215

  • Radiant Research

    Philadelphia, Pennsylvania, 19115

  • Primary Physicians Research, Inc

    Pittsburgh, Pennsylvania, 15241

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Benchmark Research

    Sacramento, California, 95816

  • J. Lewis Research, Inc. Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Inc. Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • GSA Research

    San Antonio, Texas, 78213

  • Radiant Research-San Antonio Northeast

    San Antonio, Texas, 78217

  • Radiant Research San Antonio

    San Antonio, Texas, 78229

  • Pacific Sleep Medicine Services

    San Diego, California, 92121

  • Pacific Sleep Medicine Services

    San Francisco, California, 94105

  • Clinical Research Center

    Sarasota, Florida, 34239

  • Hillcrest Family Practice

    Simpsonville, South Carolina, 29681

  • Barnes-Jewish Hospital Emergency Department

    St Louis, Missouri, 63110

  • Medex Healthcare Research, Inc.

    St Louis, Missouri, 63124

  • Radiant Research

    St Louis, Missouri, 63141

  • Balbir Chahal M.D. ,P.A

    Tomball, Texas, 77375

  • Dynamed Clinical Research

    Tomball, Texas, 77375

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • George Washington Unviersity

    Washington D.C., District of Columbia, 20037

  • J. Lewis Research, Inc./Southwest Family Medicine

    West Jordan, Utah, 84084

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

Other trials in United States

Canada11 sites

  • Calgary West Medical Cnetre Clinical Studies

    Calgary, Alberta, T3C3P1

  • Gain Medical Centre

    Coquitlam, British Columbia, V3K 3P4

  • Belvedere Medicentre

    Edmonton, Alberta, T5COA3

  • Hermitage Medicentres

    Edmonton, Alberta, T5COA3

  • RJA Medicentres

    Edmonton, Alberta, T5N2N8

  • Castledowns Medicentre

    Edmonton, Alberta, T5X3N5

  • Source Unique Clinic

    Hawkesbury, Ontario, K6A1A1

  • Omnispec Clinical Reasearch Inc

    Mirabel, Quebec, J7J 2K8

  • Prairie Clinical

    Saskatoon, Saskatchewan, S7H 5M3

  • Clinique Medicale des Campus

    Ste-Foy, Quebec, G1V4P9

  • Manna Research

    Toronto, Ontario, M9W4L6

Other trials in Canada

About this study

Official title: A Phase II, Multicenter, Randomized, Double-Mask, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza.

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.

Read the 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
Being tested
Peramivir 150 mg, Peramivir 300 mg, Placebo
Keywords
influenza, flu
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peramivir 150 mgDrug

    Also called BCX1812

    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 mgDrug

    Also called BCX1812

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

  • PlaceboDrug

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

Study groups in NCT00419263
Study groupRoleWhat they receive
Peramivir 150 mgExperimentalNot described
Receives: Drug: Peramivir 150 mg
Peramivir 300 mgExperimentalNot described
Receives: Drug: Peramivir 300 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 14 days

Secondary outcomes (6)

  1. Time to Resolution of Fever

    The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C [99.0 degrees F] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed.

    Measured: Up to 14 days

  2. Time to Resumption of Ability to Perform Usual Activities

    The time to resumption of a subject's self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment.

    Measured: Up to 14 days

  3. Change From Baseline to Day 2 in Influenza Virus Titer

    The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).

    Measured: Baseline and approximately 24 hours after treatment

  4. Change From Baseline to Day 3 in Influenza Virus Titer

    The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).

    Measured: Baseline and approximately 48 hours after treatment

  5. Change From Baseline to Day 5 in Influenza Virus Titer

    The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).

    Measured: Baseline and approximately 96 hours after treatment

  6. Change From Baseline to Day 9 in Influenza Virus Titer

    The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).

    Measured: Baseline and approximately 192 hours after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionSep 2007
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00419263
Sponsor's protocol ID
BCX1812-211
Status last verified
Jan 2015
First submitted
4 Jan 2007
Last updated
12 Feb 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peramivir 150 mg and Peramivir 300 mg in people with Influenza, run by BioCryst Pharmaceuticals at 69 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Alleviation of Symptoms (Kaplan-Meier Estimate) (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00419263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2015.

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