Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00957996
First received: August 12, 2009
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection.


Condition Intervention Phase
Seasonal Influenza
Cough
Sore Throat
Nasal Congestion
Myalgia
Headache
Fatigue
Drug: Peramivir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Randomized Study of the Antiviral Activity, Safety, and Tolerability of Intravenous Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza Infection

Resource links provided by NLM:


Further study details as provided by BioCryst Pharmaceuticals:

Primary Outcome Measures:
  • Change (reduction) in influenza virus titer measured by log10 tissue culture infective dose50 (TCID50) [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Safety and tolerability of intravenous peramivir administered as determined by serial assessments of adverse events, laboratory test results, vital signs and physical examinations. [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
  • Virology: Change (reduction) in influenza virus titer measured. [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
  • Time to Clinical Resolution [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Time to alleviation of symptoms, resolution of fever, resumption of usual activities, time to hospital discharge, incidence of influenza-related complications, duration of ICU admission after initiation of treatment and survival at 28 days.


Enrollment: 234
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peramivir 300mg
300mg twice daily
Drug: Peramivir
300mg twice daily
Experimental: Peramivir 600mg
600mg once daily
Drug: Peramivir
600mg once daily

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and non-pregnant female subjects 6 years of age or older.
  • Able to provide written informed consent, or for whom written consent may be provided by a parent guardian or legally authorized representative, unless consent provided by a parent, guardian or legally authorized representative is not consistent with applicable local or ethical procedures, directives and /or guidelines.
  • Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection; a measured temperature of ≥ 38.0°C (100.4°F) oral, or ≥ 38.6°C (101.4°F) rectal or tympanic and recent onset of at least one of the following: rhinorrhea or nasal congestion, sore throat or cough. Measured temperature can include fever meeting the above criteria as reported by the subject or their parent, guardian or legally authorized representative in the 24 hours prior to Screening. The requirement for fever is waived for any subject with influenza infection already confirmed by laboratory tests (including Rapid Antigen Tests).
  • Confirmation of influenza A or B infection in the local community by one of the following means:
  • the institution's local laboratory,
  • the local public health system
  • the national public health system
  • a laboratory of a recognized national or multinational influenza surveillance scheme.
  • Severity of illness requiring or anticipated to require in-hospital care.

Exclusion Criteria:

  • Subjects who have been hospitalized for greater than 24 hours (not including time spent in the emergency department).Blood platelet count of < 20 x 109/L.
  • Serum bilirubin > 6 mg/dL at time of Screening evaluation.
  • Serum ALT or AST > 5 X upper limit of normal at time of Screening evaluation.
  • Serum creatinine > 5.0 mg/dL at time of Screening evaluation.
  • Subjects who require peritoneal dialysis or hemofiltration.
  • Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced.
  • Females who are pregnant (positive urine or serum pregnancy test at Screening evaluation) or breastfeeding.
  • Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. (Subjects who have completed treatment 30 days prior to enrollment are allowed to enroll in the study. Hormone treatment for cancer is also acceptable).
  • Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
  • HIV infection with a known CD4 count < 200 cells/ mm3 unless on a stable highly active antiretroviral (HAART) regimen for at least 6 months.
  • Presence of a preexisting chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). (Subjects with chronic osteomyelitis or hepatitis B or C not requiring treatment are not excluded).
  • Presence of any preexisting illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study.
  • Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the Screening evaluation.
  • Subjects diagnosed with cystic fibrosis.
  • Subjects with confirmed clinical evidence of acute non-influenzal infection at the time of Screening.
  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: NCT00957996

  Show 110 Study Locations
Sponsors and Collaborators
BioCryst Pharmaceuticals
  More Information

No publications provided

Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00957996     History of Changes
Other Study ID Numbers: BCX1812-303, HHS 0100200700032C
Study First Received: August 12, 2009
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ministry of Health
Australia: Human Research Ethics Committee
New Zealand: Ministry of Health

Keywords provided by BioCryst Pharmaceuticals:
influenza
hospitalized
flu
antiviral

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 September 16, 2014