Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2013-000582-36-GB |
Date of registration:
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07/08/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults with Symptomatic Influenza A or B Infection
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Scientific title:
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults with Symptomatic Influenza A or B Infection |
Date of first enrolment:
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04/11/2013 |
Target sample size:
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636 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000582-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Bulgaria
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Canada
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Colombia
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Estonia
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France
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Germany
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Hungary
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Latvia
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Mexico
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Peru
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South Africa
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Operations
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Address:
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10/585 Blackburn Rd
3168
Notting Hill
Australia |
Telephone:
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Email:
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info@biota.com.au |
Affiliation:
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Biota Scientific Management Pty Ltd. |
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Name:
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Clinical Operations
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Address:
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10/585 Blackburn Rd
3168
Notting Hill
Australia |
Telephone:
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Email:
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info@biota.com.au |
Affiliation:
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Biota Scientific Management Pty Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Provide written informed consent
2. Males or females aged 18–64 years, inclusive
3. A female subject is eligible to enter the study if she meets following criteria:
- not pregnant or breast feeding / lactating
- females of non-childbearing potential (ie, women who had a hysterectomy, had both ovaries surgically removed or have current documentation of tubal ligation, or are postmenopausal which is defined as 1 year without menses)
- females of child bearing potential must have a negative urine pregnancy test at screening
- females of childbearing potential must agree to use adequate and highly effective methods of contraception throughout the study. Highly effective method of birth control is one of the following:
Complete abstinence from intercourse from two weeks prior to Day 1 until 1 month after their last dose of study drug.
Implants of levonorgestrel
Injectable progesterone
Intrauterine device (IUD)
Oral contraceptives (either combined or progesterone only)
Double barrier method: condom, cervical cap or diaphragm with spermicidal agent
Transdermal contraceptive patch
Male partner who is sterile prior to the female subject's entry into study and is the sole sexual partner for the female subject.
4. Male subjects with female partners of childbearing potential must use adequate and highly effective methods of contraception such as double barrier method, from screening until 1 month after their last dose of study drug.
5. Symptomatic presumptive influenza A or B infection defined as the presence of:
a. a fever of =38.0 ºC (=100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit
b. AND
c. =1 moderate systemic symptom (headache, feeling feverish, body
aches and pains, and fatigue)
AND
d. =1 moderate respiratory symptom (cough, sore throat and nasal
congestion)
6. Onset of illness no more than 40 hours prior to randomization. Onset
of illness is defined as the time, the first of any one of the following,
occurred:
a. time when the subjects' temperature was measured as elevated (=
38.0 °C (=100.4 ºF)
OR
b. time when the subject first experienced at least one respiratory
symptom (cough, sore throat and nasal congestion)
OR
c. time when the subject first experienced at least one systemic
symptom (headache, feeling feverish, body aches and pains, and
fatigue) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 636 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria: 1. Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening
2. Received live attenuated or trivalent inactivated influenza virus
vaccine in the previous 3 weeks
3. History or presence of clinically significant pulmonary disease (e.g.,
chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis)
or asthma
4. History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months
5. Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
6. Presence of clinically significant signs of acute respiratory distress during screening
7. Current use of inhaled medications (nasal or oral) or anticipated use
8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min
9. Presence of clinically significant abnormalities on ECG at screening which, in the investigator's clinical judgment, may affect either the subject's ability to participate in the study or the study results
10. History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results
11. Currently hospitalized or any planned hospitalizations within 1 month following the last dose of study drug
12. Current clinical evidence of otitis, bronchitis, sinusitis, pneumonia or active bacterial infection at any body site, that requires treatment with oral or parenteral antibiotics
13. Documented or reported (known) history of hepatitis B, hepatitis C, TB or HIV infection
14. Severe infection within 30 days prior to screening which required parenteral antibiotic use or hospitalization
15. History of or known clinically significant liver disease
16. History of, or current evidence of, abuse (in the investigator's opinion) of alcohol or any licit or illicit drug substance within the past 12 months
17. History of adverse reaction or known hypersensitivity to lactose or neuraminidase inhibitors
18. Received an investigational drug within 30 days prior to screening
19. Subjects who in the opinion of the investigator are unable to independently complete study documentation e.g. Flu-iiQ™ or selfadminister laninamivir octanoate TwinCaps® DPI
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Treatment of influenza caused by viruses type A and B
MedDRA version: 20.1
Level: LLT
Classification code 10022002
Term: Influenza A virus infection
System Organ Class: 100000004862
MedDRA version: 20.1
Level: LLT
Classification code 10022003
Term: Influenza B virus infection
System Organ Class: 100000004862
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Therapeutic area: Diseases [C] - Virus Diseases [C02]
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Intervention(s)
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Product Name: Laninamivir octanoate TwinCaps® dry powder inhaler Product Code: CS-8958 Pharmaceutical Form: Inhalation powder, pre-dispensed INN or Proposed INN: LANINAMIVIR OCTANOATE CAS Number: S900005430 Current Sponsor code: CS-8958 Other descriptive name: LANINAMIVIR OCTANOATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed Route of administration of the placebo: Inhalation use
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Primary Outcome(s)
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Secondary Objective: -To evaluate the safety and tolerability of laninamivir octanoate -To evaluate the efficacy of laninamivir octanoate -To evaluate the quantitative changes in virus shedding -To investigate the development of resistance to laninamivir by phenotypic and genotypic analyses -To investigate the impact of treatment of influenza with laninamivir octanoate on quality of life
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Primary end point(s): The primary end point for this study is time to alleviation of influenza symptoms (cough, sore throat, nasal congestion, headache, body aches and pains, feeling feverish and fatigue) and fever for =24 hours.
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Main Objective: The primary objective of the study is to evaluate the efficacy of two doses of inhaled laninamivir octanoate (40 and 80mg) delivered via TwinCaps® DPI in adults with symptomatic presumptive influenza A or B infection.
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Timepoint(s) of evaluation of this end point: The time of symptom alleviation is defined as the period from start of study drug to the start of the first 24 hour period (three consecutive measurements) in which the influenza symptoms are scored as mild or absent and fever is absent (<38.0°C/<100.4ºF).
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Secondary Outcome(s)
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Secondary end point(s): - Time to return to normal body temperature, defined as: temperature
has returned to normal (<37.2 °C /99.0 ºF) for =24 hours
- Time to alleviation of systemic influenza symptoms (headache, feeling
feverish, body aches and pains, fatigue, neck pain, interrupted sleep and
loss of appetite)
- Time to alleviation of respiratory influenza symptoms (cough, sore
throat and nasal congestion)
- Flu-iiQ symptom domain scores; systemic symptoms, respiratory
symptoms and all flu symptoms
- Area under the curve (AUC) of the duration and severity of the mean all
symptom score
- Determination of dose-response relationship in influenza infected
subjects
- Determination of the incidence of secondary bacterial infections and
the use antibiotics
- Incidence of SAEs, AEs leading treatment discontinuation, clinically significant changes in haematology, biochemistry and urinalysis
laboratory tests
- Use of concomitant medications
- Changes on clinical assessments; vital signs, ECGs, physical
examinations and spirometry
- Quantitative changes in virus shedding based on qRT-PCR and viral
culture
- Determination of the emergence of resistance to laninamivir by
phenotypic and genotypic analyses
- Quality of Life; impact on daily activities, impact on emotions and
impact on others
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Timepoint(s) of evaluation of this end point: Days 3, 5, 8, 15, and 29.
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Secondary ID(s)
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BTA51-350-201
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Source(s) of Monetary Support
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Biota Scientific Management Pty Ltd.
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Biomedical Advanced Research and Development Authority, U.S. Department of Health and Human Services
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Ethics review
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Status: Approved
Approval date:
Contact:
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