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A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza
This study is currently recruiting participants.
Verified by BioCryst Pharmaceuticals, January 2009
Sponsored by: BioCryst Pharmaceuticals
Information provided by: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00705406
  Purpose

The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.


Condition Intervention Phase
Acute, Uncomplicated Human Influenza
Drug: Peramivir
Drug: Placebo
Phase II

MedlinePlus related topics: Flu
Drug Information available for: BCX 1812
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza

Further study details as provided by BioCryst Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: Information collected daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of peramivir administered intramuscularly. [ Time Frame: Through Day 14 ] [ Designated as safety issue: Yes ]
  • To evaluate changes in influenza virus titer in nasopharyngeal samples (viral shedding) in response to treatment. [ Time Frame: Through Day 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: July 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Peramivir 600 mg: Experimental
600 mg peramivir administered as bilateral 2mL intramuscular injection.
Drug: Peramivir
600 mg peramivir administered as bilateral 2mL intramuscular injection
Placebo: Placebo Comparator
Placebo (buffered diluent) administered as bilateral 2mL intramuscular injection.
Drug: Placebo
Placebo (buffered diluent) administered as bilateral 2mL intramuscular injection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and non-pregnant female subjects age ≥18 years.
  • A positive Influenza A 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 36 hours before presentation for screening.
  • Written informed consent.

Exclusion Criteria:

  • 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 heart failure or angina 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.
  • Receipt of any intramuscular injection with the previous 7 days.
  • History of alcohol abuse or drug addiction within 1 year prior to admission in the study.
  • Participation in a previous study of intramuscular or intravenous peramivir or previous participation in this study.
  • Participation in a study of any investigational drug or device within the last 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705406

Contacts
Contact: Julie Daves 919-859-7918 jdaves@biocryst.com
Contact: Connie Morris 919-859-7911 cmorris1@biocryst.com

  Show 106 Study Locations
Sponsors and Collaborators
BioCryst Pharmaceuticals
  More Information

Responsible Party: BioCryst Pharmaceuticals ( Connie Morris )
Study ID Numbers: BCX1812-212
Study First Received: June 24, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00705406  
Health Authority: United States: Food and Drug Administration;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Australia: National Health and Medical Research Council;   New Zealand: Medsafe;   South Africa: Medicines Control Council

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009