Clinical Trials Register

Summary
EudraCT Number:	2009-012367-34
Sponsor's Protocol Code Number:	BCX1812-301
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-09-22
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2009-012367-34

A.3

Full title of the trial

A Phase 3, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of Peramivir Administered Intravenously in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents who are Hospitalized due to Serious Influenza.

A.4.1

Sponsor's protocol code number

BCX1812-301

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	BioCryst Pharmaceuticals, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	United States Department of Health and Human Services
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	BioCryst Pharmaceuticals
B.5.2	Functional name of contact point	Laura Gibson
B.5.3	Address:
B.5.3.1	Street Address	4505 Emperor Blvd, Suite 200
B.5.3.2	Town/ city	Durham
B.5.3.3	Post code	27502
B.5.3.4	Country	United States
B.5.4	Telephone number	0019192265857
B.5.5	Fax number	0019198511416
B.5.6	E-mail	lgibson@Biocryst.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Peramivir
D.3.2	Product code	BCX-1812
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	330600-85-6
D.3.9.2	Current sponsor code	BCX-1812
D.3.9.3	Other descriptive name	Peramivir
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Influenza

E.1.1.1

Medical condition in easily understood language

Flu

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10022000
E.1.2	Term	Influenza
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

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.

E.2.3

Trial contains a sub-study

E.3

Principal 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 <92%, OR
c. Two out of the following three vital signs:
• Respiration rate >24/minute
• Heart rate >100/minute
• Systolic BP <90 mmHg

4. Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion) of any severity (mild, moderate, or severe).

5. Presence of at least one constitutional symptom (headache, myalgia, feverishness, or fatigue) of any severity (mild, moderate, or severe).

6. Onset of illness no more than 72 hours before presentation. Note: Time of onset of illness is defined as the earlier of either (1) the time when the temperature was first measured as elevated, OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.

7. Either:
Severity of illness that, in the Investigator’s judgment, justifies hospitalization of the subject for supportive care.
OR
Presence of one or more of the following factors:
•Age ≥60 years.
•Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy.
•Current history of congestive heart failure or angina.
•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 (an investigative site at altitude >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 institution in the current influenza season.

E.4

Principal 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 < 20 x 1,000,000,000/L at the time of the screening evaluation.

4. Serum bilirubin > 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 breatsfeeding.

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 with confirmed clinical evidence 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.

E.5 End points

E.5.1

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

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

End of Trial will be the last patient, last visit undergoing the trial.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

228

F.4.2.2

In the whole clinical trial

600

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Intravenous study treatment will be continued after hospital discharge if the subject has not received the planned 5 daily doses of intravenous study medication, or if the subject meets the criteria to continue their assigned treatment after Day 5.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2009-12-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-11-18

P. End of Trial
P.	End of Trial Status	Completed

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