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A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.

This study has been terminated.
(This study was terminated for administrative reasons)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01224795
First received: October 19, 2010
Last updated: December 14, 2011
Last verified: December 2011

October 19, 2010
December 14, 2011
October 2010
November 2010   (final data collection date for primary outcome measure)
To evaluate the efficacy of peramivir administered intravenously compared to placebo on the time to alleviation of clinical symptoms with acute uncomplicated influenza. [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
Time to alleviation of clinical symptoms in adolescents and adults with uncomplicated acute influenza measured from patient reported study diaries.
Same as current
Complete list of historical versions of study NCT01224795 on ClinicalTrials.gov Archive Site
To evaluate the safety and tolerability of peramivir administered intravenously [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

To evaluate time to resolution of fever in response to treatment. To evaluate changes in influenza virus titer in nasal and pharyngeal samples (viral shedding) in response to treatment.

To evaluate secondary clinical outcomes and changes in virus susceptibility to neuraminidase inhibitors in response to treatment.

Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.
A Phase III, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.

This is a study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute uncomplicated influenza.

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute,uncomplicated influenza.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Influenza
  • Drug: Peramivir
    Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to < 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.
  • Drug: Placebo Comparator
    Placebo Peramivir, administered intravenously.
  • Experimental: Peramivir
    Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to < 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.
    Intervention: Drug: Peramivir
  • Placebo Comparator: Placebo
    Placebo Peramivir, administered intravenously.
    Intervention: Drug: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and non-pregnant female subjects age ≥12 years.
  • Test positive for influenza A or B by Rapid Antigen Test (RAT) performed with a commercially available test on an adequate anterior nasal specimen in accordance with the manufacturer's instructions.
  • 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/assent.

Exclusion Criteria:

  • Women who are pregnant or breast-feeding.
  • Employees of the study site, or immediate family members of study site employees.
  • 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.
  • 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 media,bronchitis, sinusitis and/or pneumonia, or active bacterial infection of 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 ic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening.
  • Presence of known HIV infection with a CD4 count <350 cell/mm3.
  • Receipt of any dose of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
  • Immunization 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 intramuscular or intravenous peramivir, or previous exposure to peramivir.
  • Participation in a study of any investigational drug or device within the last 30 days.
  • Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
  • Presence of any pre-existing illness that in the opinion of the investigator would make the subject unable to comply with the protocol.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224795
BCX1812-304, HHS 0100200700032C
Yes
BioCryst Pharmaceuticals
BioCryst Pharmaceuticals
Department of Health and Human Services
Not Provided
BioCryst Pharmaceuticals
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP