InfluenzaPhase 3NCT00486980
Intramuscular Peramivir for the Treatment of Uncomplicated Influenza
A Phase 3 study testing Peramivir 150mg and Peramivir 300mg in people with Influenza, run by BioCryst Pharmaceuticals.
Trial summary
This is a multinational, randomized, double-blind study comparing the efficacy and safety of two single dose regimens of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza. 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 150mg and Peramivir 300mg
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Male and non-pregnant female subjects age ≥18 years
- A Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab. A negative initial RAT may be repeated within one hour of obtaining a negative result.
- 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. For subjects with a positive RAT at the time of screening, 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 time of screening. For subjects with no positive RAT at screening, fever as defined above must be documented at time of 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 (myalgia [muscle aches], headache, feverishness, or fatigue) of any severity (mild, moderate, or severe)
- Onset of symptoms no more than 48 hours before presentation for screening
- Written informed consent
Who cannot join
- 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 congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class IV functional status within the past 12 months
- 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)
- Current clinical evidence of active bacterial infection at any body site that requires therapy with oral or systemic antibiotics
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- Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy
- Current treatment for active 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
- History of alcohol abuse or drug addiction within 1 year prior to admission in the study
- Participation in a previous study of peramivir as treatment for acute influenza or previous participation in this study
- Participation in a study of any investigational drug within the last 30 days
About this study
Official title: A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAMUSCULAR PERAMIVIR IN SUBJECTS WITH UNCOMPLICATED ACUTE INFLUENZA
This is a multinational, randomized, double-blind study comparing the efficacy and safety of two single dose regimens of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza.
- Conditions
- Influenza
- Being tested
- Peramivir 150mg, Peramivir 300mg
- Keywords
- influenza
- 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 150mgDrug
Peramivir 300mgDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
Why it stopped: This study was withdrawn for administrative reasons. The dose ranging plan for the program was revised".
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486980
- Sponsor's protocol ID
- BCX1812-312
- Status last verified
- May 2026
- First submitted
- 14 Jun 2007
- Last updated
- 1 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAMUSCULAR PERAMIVIR IN SUBJECTS WITH UNCOMPLICATED ACUTE INFLUENZA
- ClinicalTrials.gov ID
- NCT00486980
- Acronym / sponsor ID
- BCX1812-312
- Conditions
- Influenza
- Keywords
- influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn for administrative reasons. The dose ranging plan for the program was revised".
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 15 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multinational, randomized, double-blind study comparing the efficacy and safety of two single dose regimens of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and non-pregnant female subjects age ≥18 years
- A Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab. A negative initial RAT may be repeated within one hour of obtaining a negative result.
- 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. For subjects with a positive RAT at the time of screening, 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 time of screening. For subjects with no positive RAT at screening, fever as defined above must be documented at time of 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 (myalgia [muscle aches], headache, feverishness, or fatigue) of any severity (mild, moderate, or severe)
Key exclusion criteria (15 listed)
- 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 congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class IV functional status within the past 12 months
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peramivir 150mg | Drug | – |
| Peramivir 300mg | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peramivir 150mg and Peramivir 300mg in people with Influenza, run by BioCryst Pharmaceuticals.
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 7 inclusion and 15 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: withdrawn, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 1 Jun 2026.