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Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza

Information source: BioCryst Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Peramivir 200 mg (Drug); Peramivir 400 mg (Drug); Oseltamivir (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: BioCryst Pharmaceuticals

Summary

This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.

Clinical Details

Official title: Phase II, Multicenter, Randomized, Double-Mask, Double-Dummy Study Comparing Efficacy and Safety of Intravenous Peramivir Once Daily Versus Oral Oseltamivir Twice Daily in Adults With Acute Serious or Potentially Life-Threatening Influenza

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to Clinical Stability (Kaplan-Meier Estimate)

Secondary outcome:

Change From Baseline in Scores of Symptoms of Influenza

Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)

Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)

Time to Hospital Discharge (Kaplan-Meier Estimate)

Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age ≥18 years of age, male or female

- Able to provide informed consent, or for whom consent may be provided by guardian

- Presence of fever at time of screening of ≥38. 0°C (≥ 100. 0°F) taken orally, or

≥38. 5°C (≥101. 2°F) taken rectally. This requirement is waived if the subject has (1) a history of fever within 24 hours prior to screening and administered any antipyretic(s) in the 24 hours prior to screening, or (2) has no history of documented fever as defined above, but reports a symptom of feverishness at some time during 48 hours prior to screening

- Presence of at least 1 respiratory symptom (cough, sore throat, nasal

congestion/symptoms) of any severity (mild, moderate, severe)

- Presence of at least 1 constitutional symptom (headache, myalgia, feverishness,

malaise, fatigue) of any severity (mild, moderate, severe)

- Onset of illness no more than 72 hours before presentation. Time of onset of illness

defined as either (1) the time when temperature (oral or rectal) was elevated (at least 1°C of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least 1 respiratory symptom AND the presence of at least 1 constitutional symptom

- Presence of 1 or more of the following factors in a subject willing to be

hospitalized for inpatient observation and treatment:

- Age ≥60 years

- Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung

disease requiring daily pharmacotherapy

- History of congestive heart failure with or without medically significant recent

change in cardiac status, but without signs or symptoms compatible with NYHA Class IV functional status

- Presence of diabetes mellitus, clinically stable or unstable

- Transcutaneous oxygen saturation <94% without supplemental oxygen for at least 5

minutes, or a medically significant decrease in oxygen saturation from an established baseline value

- Systolic blood pressure <90 mmHg

- Severity of illness that, in the Investigator's judgment, justifies hospitalization

of the subject for supportive care

- Positive rapid antigen test (RAT) for influenza A and/or influenza B (using an

approved test kit) or other test for influenza virus antigen performed in a clinical laboratory at the screening/enrollment evaluation

- Females of childbearing potential must report one of the following:

- Be surgically sterile or clinically post-menopausal

- Have been sexually abstinent 4 weeks prior to date of screening evaluation and be

willing to remain abstinent through 4 weeks after study-drug administration for all perimenopausal women or women of child-bearing potential

- Use oral contraceptives or other form of hormonal birth control including hormonal

vaginal rings or transdermal patches and have been using these for 3 months prior through 4 weeks after study-drug administration for all perimenopausal women or women of child-bearing potential

- Use an intra-uterine device (IUD), or adequate barrier contraception (or

double-barrier method such as condom or diaphragm with spermicidal gel or foam) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration for all perimenopausal women or women of child-bearing potential Exclusion Criteria:

- Immunized against influenza with live attenuated virus vaccine in the previous weeks

- Treatment with any dose(s) of rimantadine, amantadine, zanamivir, or oseltamivir in

the previous 7 days

- Current clinical evidence of a recognized or suspected acute non-influenzal

infectious illness with onset prior to Screening

- Serum creatinine laboratory result at Screening >1. 6 mg/dL or a result >25% above the

upper limit of normal for the laboratory performing the test

- History of clinically significant proteinuria (≥1000 mg/24 hrs)

- History of moderate or severe renal impairment and/or previous clinical laboratory

data indicating an estimated creatinine clearance <50 mL/min during the previous 12 months

- Electrocardiogram (ECG) at Screening visit showing evidence of acute ischemia, or

presence of a medically significant dysrhythmia

- Presence of cardiac signs or symptoms compatible with NYHA Class III or Class IV

functional status for congestive heart failure or angina (see NYHA Appendix V)

- Presence of diagnosed COPD or other chronic lung condition requiring either

continuous or intermittent oxygen therapy as an outpatient. Note: Subjects who are determined to require acute supplemental oxygen therapy at the time of Screening and/or at hospital admission may be enrolled, if exclusion criteria #13 or #14 are not applicable.

- History of organ transplantation during the previous 12 months

- Known HIV infection with most recent CD4+ T-cell count ≤350 cells/mL

- History of diagnosis of any type of cancer (hematologic or solid tumor), that has

required chemotherapy or radiation therapy in the previous 12 months, excluding non-melanomatous localized skin cancer

- Presence of ongoing requirement for chronic mechanical ventilation, either via oral

or nasotracheal intubation or via tracheostomy, or chronic or intermittent requirement for BiPAP (bilevel positive airway pressure) at screening. Note: Subjects who require intermittent CPAP treatment for sleep apnea (without oxygen supplementation) may be enrolled

- Subjects who require acute mechanical ventilatory support of any type at the time of

screening.

- History of alcohol abuse or drug addiction during the previous 12 months

- Participation in a clinical study of an experimental medication or other treatment

during the previous 4 weeks

- Previous treatment with intravenous or intramuscular peramivir

- Women who are pregnant (positive serum or urine pregnancy test), who are attempting

to become pregnant, or who are breast-feeding

- Subjects who have been hospitalized due to a condition other than acute influenza and

in whom influenza is diagnosed during hospitalization.

Locations and Contacts

Centre Hospitalier Universitaire de Quebec-Pavillon CHUL, Quebec G1V 4G2, Canada

Princess Margaret Hospital, Hong Kong, Hong Kong

Queen Mary Hospital, Hong Kong, Hong Kong

United Christian Hospital, Hong Kong, Hong Kong

The Prince of Wales Hospital, Shatin - New Territories, Hong Kong

Christchurch Hospital, Christchurch, New Zealand

Waikato Hospital, Hamilton, New Zealand

Tauranga Hospital, Tauranga 3110, New Zealand

National University Hospital, Singapore 169608, Singapore

Tan Tock Seng Hospital, Singapore 308433, Singapore

Pulmonary Associates of Mobile, P.C., Mobile, Alabama 36608, United States

St. Bernards Research Center/Clopton Clinic, Jonesboro, Arkansas 72401, United States

Kelowna General Hospital, Kelowna, British Columbia V1Y 3T1, Canada

Pulmonary Consultants & Primary Care Physicians Medical Group, Inc., Orange, California 92868, United States

University of California Irvine Medical Center, Orange, California 92868, United States

University of California Davis Medical Center, Department of Emergency Medicine, Sacramento, California 95817, United States

Good Samaritan Hospital, San Jose, California 95124, United States

National Jewish Medical and Research Center, Clinical Research Unit, Denver, Colorado 80206, United States

Global Clinical Trial Center, Port Elizabeth, E. Cape 6020, South Africa

Orlando Regional Healthcare, Orlando, Florida 32806, United States

James A. Haley Veterans Hospital, Department of Infectious Disease, Tampa, Florida 33612, United States

Genclin Corporation, Bloemfontein, Free State 9301, South Africa

Benmed / Pentagon Hospital, Benoni, Gauteng 1500, South Africa

Private Practice, Cape Town, Gauteng 1724, South Africa

Newgate Centre, Johannesburg,, Gauteng 2001, South Africa

DJW Navorsing, Krugersdorp, Gauteng 1739, South Africa

Eugene Marais Hospital, Pretoria, Gauteng 0084, South Africa

Global Clinical Trials (GCT), Pretoria, Gauteng 0186, South Africa

Medforum Hospital, Pretoria, Gauteng 0001, South Africa

Dr Bhorat, Soweto, Gauteng 1818, South Africa

Medical College of Georgia, Augusta, Georgia 30912, United States

Infectious Disease Specialists of Atlanta, P.C., Decatur, Georgia 30033, United States

St. Joseph's/Candler Health System, Inc., Savannah, Georgia 31405, United States

Idaho Falls Infectious Diseases, PLLC, Idaho Falls, Idaho 83404, United States

Northwestern University, Chicago, Illinois 60611, United States

Springfield Clinic, LLP, Springfield, Illinois 62701, United States

Infectious Disease of Indiana, PSC, Indianapolis, Indiana 46280, United States

Wishard Hospital/Indiana University, Indianapolis, Indiana 46202, United States

Sebastian, P, Durban, KZ-Natal 4001, South Africa

Natchitoches Internal Medicine, Natchitoches, Louisiana 71457, United States

Louisiana State University Health Sciences Center-Shreveport, Shreveport, Louisiana 71103, United States

Franklin Square Hospital, Baltimore, Maryland 21237, United States

VA Maryland Health Care System, Baltimore, Maryland 21201, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Wayne State University School of Medicine, Detroit, Michigan 48201, United States

William Beaumont Hospital Troy, Troy, Michigan 48085, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Mercury Street Medical Group, PLLC, Butte, Montana 59701, United States

Eksteen, MC, Nelspruit, Mpumalanga 1201, South Africa

Hackensack University Medical Center, Department of Infectious Disease, Hackensack, New Jersey 07601, United States

Jersey Shore University Medical Center, Neptune, New Jersey 07754, United States

University of New Mexico, Albuquerque, New Mexico 87131-0001, United States

Prince Of Wales Hospital, Randwick, New South Wales 2031, Australia

Westmead Hospital, Wentworthville, New South Wales 2145, Australia

Rochester General Hospital/University of Rochester, Rochester, New York 14621-3001, United States

University of Rochester Medical Center, Rochester, New York 14642, United States

University Hospitals Case Medical Center, Cleveland, Ohio 44106-5083, United States

Hamilton Health Sciences-McMaster University Medical Centre, Hamilton, Ontario L8N 3Z5, Canada

St. Joseph's Healthcare Hamilton-L424, Hamilton, Ontario L8N 4A6, Canada

The Ottawa Hospital - General Campus, Ottawa, Ontario K1H 8L6, Canada

Mount Sinai Hospital / Toronto Medical Laboratories, Toronto, Ontario M5G 1X5, Canada

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

Center de Sante et des Services Sociaux de Chicoutimi, Chicoutimi, Quebec G7H 5H6, Canada

Maisonneuve-Rosemont Hospital, Montreal, Quebec H1T 2M4, Canada

Centre de sante et de services sociaux Rimouski-Neigette (CSSSRN), Rimouski, Quebec G5L 5T1, Canada

Cairns Base Hospital, Cairns, Queensland 4870, Australia

Mater Adult Hospital, South Brisbane, Queensland 4101, Australia

Gold Coast Hospital, Southport, Queensland 4215, Australia

Princess Alexandra Hospital, Woolloongabba, Queensland 4102, Australia

Division of Infectious Diseases, Saskatoon, Saskatchewan S7N 0W8, Canada

Repatriation General Hospital, Daw Park, South Australia 5041, Australia

Lowcountry Infectious Diseases, P.A., Charleston, South Carolina 29414, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Utah Health Sciences Center, Salt Lake City, Utah 84132, United States

Royal Melbourne Hospital, Parkville, Victoria 3050, Australia

Veterans Affairs Medical Center, Salem, Virginia 24153, United States

Dr. L.J. van Zyl, Worcester, W Cape 6850, South Africa

N1 City Hospital, Cape town, WC 7460, South Africa

Franciscan Health System, Tacoma, Washington 98405, United States

Sir Charles Gairdner Hospital, Nedlands, Western Australia 6060, Australia

Marshfield Clinic, Marshfield, Wisconsin 54449-5703, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226-3522, United States

Additional Information

Starting date: July 2007
Last updated: January 28, 2015

Page last updated: August 23, 2015

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