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
  Purpose

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.


Condition Intervention Phase
Influenza
Drug: Peramivir
Drug: Placebo Comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.

Resource links provided by NLM:


Further study details as provided by BioCryst Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 1
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Placebo Comparator: Placebo
Placebo Peramivir, administered intravenously.
Drug: Placebo Comparator
Placebo Peramivir, administered intravenously.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224795

  Show 96 Study Locations
Sponsors and Collaborators
BioCryst Pharmaceuticals
  More Information

No publications provided

Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01224795     History of Changes
Other Study ID Numbers: BCX1812-304, HHS 0100200700032C
Study First Received: October 19, 2010
Last Updated: December 14, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by BioCryst Pharmaceuticals:
uncomplicated influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014