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

Sponsor

BioCryst Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01224795

Collaborator

Department of Health and Human Services (U.S. Fed)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Influenza	Drug: Peramivir Drug: Placebo Comparator	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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. [14 Days]
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 [14 Days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Hot Springs	Arkansas	United States
3	Jonesboro	Arkansas	United States
4	Little Rock	Arkansas	United States
5	Mountain Home	Arkansas	United States
6	Anaheim	California	United States
7	Buena Park	California	United States
8	Chino	California	United States
9	Dinuba	California	United States
10	Garden Grove	California	United States
11	Lincoln	California	United States
12	Los Angeles	California	United States
13	Oceanside	California	United States
14	Palm Springs	California	United States
15	Port Hueneme	California	United States
16	Sacramento	California	United States
17	San Diego	California	United States
18	Tustin	California	United States
19	West Covina	California	United States
20	Boulder	Colorado	United States
21	Centennial	Colorado	United States
22	Wheat Ridge	Colorado	United States
23	Milford	Connecticut	United States
24	Brooksville	Florida	United States
25	Coral Gables	Florida	United States
26	Cutler Bay	Florida	United States
27	Daytona Beach	Florida	United States
28	Edgewater	Florida	United States
29	Gainsville	Florida	United States
30	Hialeah	Florida	United States
31	Jacksonville	Florida	United States
32	Miami	Florida	United States
33	South Miami	Florida	United States
34	West Palm Beach	Florida	United States
35	Stockbridge	Georgia	United States
36	Boise	Idaho	United States
37	Aurora	Illinois	United States
38	Bloomingdale	Illinois	United States
39	Chicago	Illinois	United States
40	Peoria	Illinois	United States
41	South Bend	Indiana	United States
42	Dubuque	Iowa	United States
43	Arkansas City	Kansas	United States
44	Lenexa	Kansas	United States
45	Bardstown	Kentucky	United States
46	Hazard	Kentucky	United States
47	Paducah	Kentucky	United States
48	Baton Rouge	Louisiana	United States
49	Shreveport	Louisiana	United States
50	Bangor	Maine	United States
51	Hollywood	Maryland	United States
52	Rockville	Maryland	United States
53	Brockton	Massachusetts	United States
54	Fall River	Massachusetts	United States
55	Washington	Missouri	United States
56	Bozeman	Montana	United States
57	Fremont	Nebraska	United States
58	Lincoln	Nebraska	United States
59	Omaha	Nebraska	United States
60	Albuquerque	New Mexico	United States
61	Camillus	New York	United States
62	Raleigh	North Carolina	United States
63	Winston-Salem	North Carolina	United States
64	Fargo	North Dakota	United States
65	Akron	Ohio	United States
66	Dayton	Ohio	United States
67	Wadsworth	Ohio	United States
68	Owasso	Oklahoma	United States
69	Bend	Oregon	United States
70	Medford	Oregon	United States
71	Hatfield	Pennsylvania	United States
72	Philadelphia	Pennsylvania	United States
73	Scotland	Pennsylvania	United States
74	Cranston	Rhode Island	United States
75	Cumberland	Rhode Island	United States
76	Johnston	Rhode Island	United States
77	Easley	South Carolina	United States
78	Greenville	South Carolina	United States
79	Bristol	Tennessee	United States
80	Arlington	Texas	United States
81	Austin	Texas	United States
82	Beaumont	Texas	United States
83	Bryan	Texas	United States
84	Dallas	Texas	United States
85	Forth Worth	Texas	United States
86	Georgetown	Texas	United States
87	Houston	Texas	United States
88	Lake Jackson	Texas	United States
89	North Richland Hills	Texas	United States
90	San Antonio	Texas	United States
91	Spring	Texas	United States
92	Salt Lake City	Utah	United States
93	South Jordan	Utah	United States
94	West Jordan	Utah	United States
95	Arlington	Virginia	United States
96	Charlottesville	Virginia	United States

Sponsors and Collaborators

BioCryst Pharmaceuticals
Department of Health and Human Services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BioCryst Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01224795

Other Study ID Numbers:

BCX1812-304
HHS 0100200700032C

First Posted:

Oct 20, 2010

Last Update Posted:

Jan 6, 2015

Last Verified:

Dec 1, 2014

Keywords provided by BioCryst Pharmaceuticals

uncomplicated influenza

Additional relevant MeSH terms:

Influenza, Human

Peramivir

Study Results

No Results Posted as of Jan 6, 2015