Influenza MedDRA version: 14.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Peramivir
Product Code: BCX-1812
Pharmaceutical Form: Solution for infusion
CAS Number: 330600-85-6
Current Sponsor code: BCX-1812
Other descriptive name: Peramivir
Concentration unit: m
Sponsors
BioCryst Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =12 years of age, male or female. 2. Able to provide informed consent/assent, or for whom consent may be provided by guardian, unless informed consent provided by a guardian or a legally authorized representative is not consistent with applicable local or ethical concerns, procedures, directives and/or guidelines. 3. Subject must have at least one of the following clinical presentations at Screening: a. Oral temperature = 38.0 °C (=100.4 °F), =38.6°C (=101.4 °F) tympanic or rectal OR b. Oxygen saturation 24/minute • Heart rate >100/minute • Systolic BP 2000 ft above sea level will utilize different criteria for oxygen saturation). •History of chronic renal impairment not requiring peritoneal dialysis. •Serum creatinine > 2.0 mg/dL or > 177 µmol/L. 8. Diagnosis of Influenza by satisfying one of the following: a. Clinical Influenza with Positive Diagnostic Test. Subjects who have a positive rapid antigen test (RAT) for influenza A and/or influenza B (using a Sponsor-approved test kit), or positive test (using other methodology) for influenza A and/or B virus antigen or RNA performed in a clinical laboratory at the screening/enrollment evaluation are eligible for enrollment. OR b. Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with a negative RAT test may be enrolled once the site has been approved by the Sponsor to enroll such subjects, based on documentation of an outbreak of influenza in the community. An influenza outbreak may be documented in the catchment area of the hospital via one of the following methods: 1) local confirmation of influenza A or B infection in the current influenza season by a) the institution’s local laboratory, or b) the local public health system, or c) the national public health system, or d) a laboratory of a recognized multinational influenza surveillance scheme such as the European Influenza Surveillance Network (EISN); 2) prior enrollment of a RAT positive subject into this study at the same instituti
Exclusion criteria
Exclusion criteria: 1. Subjects who have been hospitalized for greater than 24 hours (not including time spent in the Emergency Department). 2. Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, or oseltamivir in the previous 7 days. 3. Blood platelet count of 6 mg/dL or >102. 6 µmol/L at time of screening evaluation. 5. Serum ALT or AST > 5 times the upper limit of normal at time of screening evaluation. 6. Congestive heart failure of NYHA Class III or Class IV functional status. 7. Serum creatinine > 5.0 mg/dL or > 442 µmol/L at time of screening evaluation. 8. Subjects who require peritoneal dialysis. 9. Altered neurologic status as defined by a Glasgow Coma Score of = 9, unless medically induced. 10. Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or breastfeeding. 11. Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. Subjects who have completed treatment 30 days prior to enrollment are not excluded. Hormone treatment for cancer is also not excluded. 12. Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months. 13. HIV infection with a known CD4 count < 200 cells/mm3 unless on a stable highly active antiretroviral therapy (HAART) for at least 6 months. 14. Presence of a pre-existing 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. 15. 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. 16. Previous treatment with intravenous or intramuscular peramivir. 17. 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. 18. Subjects diagnosed with Cystic Fibrosis. 19. Subjects confirmed clinical eveidence of acute non-influenzal infection at the time of screening evaluation. 20. Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Evaluate the safety and tolerability of peramivir plus SOC compared to placebo plus SOC in adults and adolescents who are hospitalized with influenza, hereafter shortened to "peramivir vs. placebo". Evaluate changes in viral shedding associated with treatment with "peramivir vs. placebo". Evaluate the effect on time to alleviation of symptoms, time to resumption of usual daily activities, time to hospital discharge, incidence and duration of ICU admission after initiation of treatment, incidence of influenza-related complications and mortality associated with treatment with "peramivir vs. placebo". Evaluate changes in viral phenotype and genotype between baseline and post-treatment samples associated with treatment with "peramivir vs. placebo". To describe the pharmacokinetics of peramivir in adults and adolescents who are hospitalized with influenza infection. ;Primary end point(s): Time to clinical resolution as defined as the time in hours from initiation of study treatment until resolution of at least 4 of the 5 signs described below within the respective resolution criteria shown, maintained for at least 24 hours: Note: It is mandatory that both temperature and oxygen saturation meet Resolution Criteria in order for the clinical resolution endpoint to be met. Sign of Clinical Resolution Resolution Criteria Temperature =37.2 °C (=99 °F) oral =37.8°C (=100°F) rectal or tympanic Oxygen saturation =92% Respiration rate =24/minute Heart rate =100/minute Systolic BP =90 mm Hg ;Main Objective: To evaluate the effect of treatment with peramivir plus standard of care (SOC) compared to placebo plus SOC on time to clinical resolution in adults and adolescents who are hospitalized with influenza. | — |
Countries
Belgium, Bulgaria, Czech Republic, Germany, Hungary, Latvia, Slovakia, United Kingdom
Contacts
Public ContactLaura Gibson
BioCryst Pharmaceuticals
Outcome results
None listed