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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02654171




Registration number
NCT02654171
Ethics application status
Date submitted
4/01/2016
Date registered
13/01/2016
Date last updated
31/05/2019

Titles & IDs
Public title
Viral Inhibition in Children for Treatment of RSV
Scientific title
A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered AK0529 to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Single and Multiple Dosing in Hospitalized Infants With Respiratory Syncytial Virus Infection
Secondary ID [1] 0 0
AK0529-1003
Universal Trial Number (UTN)
Trial acronym
VICTOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
RESPIRATORY SYNCYTIAL VIRUS INFECTIONS 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AK0529
Treatment: Drugs - Placebo

Experimental: AK0529 - Subjects will receive single or multiple doses of AK0529 at different dose levels within different cohorts.

Placebo Comparator: Placebo - Patients who are randomized to the control arm within each cohort will receive the corresponding placebo to AK0529.


Treatment: Drugs: AK0529
AK0529 is a novel compound being developed for the treatment of RSV infection. The enteric coated drug pellets with sugar core can be administered orally with apple sauce/purée or yoghurt, or by flushing with 10% dextrose water via a nasogastric or other feeding tube, or upon a glucose wafer.

Treatment: Drugs: Placebo
The placebo was made with the same smell and appearance as AK0529 but without the active ingredients. The placebo supplements are composed primarily of microcrystaline cellulose pellet.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events during the study
Timepoint [1] 0 0
Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2)
Primary outcome [2] 0 0
Subject withdrawals due to Adverse Events
Timepoint [2] 0 0
Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2)
Secondary outcome [1] 0 0
Area under the plasma concentration-time curve from time 0 to infinity (AUC) - For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Timepoint [1] 0 0
Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Secondary outcome [2] 0 0
Maximum plasma concentration of AK0529 (Cmax) - For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Timepoint [2] 0 0
Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Secondary outcome [3] 0 0
Plasma concentration of AK0529 at 12 hours postdose (C12) - For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Timepoint [3] 0 0
Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Secondary outcome [4] 0 0
Apparent total body clearance (CL/F) - For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Timepoint [4] 0 0
Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Secondary outcome [5] 0 0
Apparent central compartment volume of distribution (Vc/F) - For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
Timepoint [5] 0 0
Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 )
Secondary outcome [6] 0 0
Area under curve change of viral load - The antiviral effects in infants hospitalized with RSV are to be determined by measuring the RSV viral load area under the curve in nasal, pharyngeal and tracheal washes / aspirates from baseline to last administration of study medication (Day 5).
Timepoint [6] 0 0
From baseline to Day 5
Secondary outcome [7] 0 0
Incidence of F-protein genotypes - The incidence of F-protein genotypes associated with reduced sensitivity to IMP will be evaluated.
Timepoint [7] 0 0
Specimen will be collected predose and 24 hours postdose on Day 1 (Part 1) and on Day 1-5 (Part 2).
Secondary outcome [8] 0 0
Change of symptom score - To evaluate the change of RSV related symptom score in AK0529 arms compared with the change in placebo arm after treatment. The total score is reported with a range from 0 to 12. A decreasing value of total score represents clinical improvement. Subscales are not applicable in this symptom score.
Timepoint [8] 0 0
From baseline to Day 1 (Part 1) and up to Day 5 after multiple drug administration (Part 2).

Eligibility
Key inclusion criteria
- Male or female patients of any race or ethnicity with an age adjusted for any
prematurity of =1 month and =24 months.

- Diagnosis of RSV infection by virological means, which may include rapid diagnostic
point-of-care testing, within 96 hours preceding screening for Part 1 and 72 hours for
Part 2.

- Patient must weigh >3 kg at screening and be within the 10th and 90th percentiles
(inclusive) for the patient's age, based on the local child growth standards, i.e. the
Australian Paediatric Endocrine Group Growth Charts.

- The parent / legal guardian of the patient must have provided written informed consent
for the patient to participate.

- For patients aged <12 months, an occipito-frontal head circumference within the normal
range for age and gender.
Minimum age
1 Month
Maximum age
24 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- The patient has taken, is currently taking or requires any restricted medications.

- Patient is known to be HIV-positive (or the mother, if the potential patient is a
child aged <6 months).

- Participation in an investigational drug or device study within 30 days prior to the
date of screening.

- Requires vasopressors or inotropic support at the time of enrolment.

- Concurrent gastrointestinal conditions that could, in the opinion of the investigator,
prejudice absorption of the Investigational Medicinal Product (e.g. protracted
vomiting, malabsorption syndrome, a history of necrotising enterocolitis with
consequent short gut syndrome).

- Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation at
the time of enrolment.

- Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia,
sequestration syndromes, cystadenomatoid malformation, a history of surgery for
diaphragmatic hernia).

- Left to right shunt meriting corrective therapy.

- Renal failure including renal anomalies likely to be associated with renal
insufficiency (e.g. clinical conditions of renal dysplasia, polycystic renal disease,
renal agenesis).

- Clinical evidence of hepatic decompensation (e.g. hepatic disorder with associated
coagulopathy or associated encephalopathy).

- Cerebral palsy with microcephaly, chronic or persistent feeding difficulties or
seizures.

- Symptomatic because of inborn errors of metabolism (e.g. mitochondrial disorders,
disorders of carbohydrate metabolism, glycogen storage disorders).

- Congenital or acquired immunodeficiency (e.g. congenital agammaglobulinaemia, common
variable immunodeficiency, immunosuppressive therapy other than glucocorticoid or
montelukast therapy forming part of care directed by the treating physician).

- For Part 2 of this study, children with a history of having received palivizumab or
any other monoclonal agent directed against RSV in the preceding 120 days. This
exclusion criterion does not apply to Part 1.

- Evidence of active or uncontrolled respiratory, cardiac, hepatic, central nervous
system or renal disease unrelated to RSV infection at baseline or any other medical
condition that in the opinion of the investigator renders the patient unsuitable for
enrolment.

- A history of epilepsy or seizures including febrile seizures.

- Allergy to test medication or constituents.

- Weight less than 10th percentile or greater than 90th percentile for age and gender
adjusted for any prematurity.

- The patient's parent or legally acceptable representative is an employee of the
investigator or the study center, with direct involvement in the proposed study or
other studies under the direction of that investigator of the study center, or any
family members of the employees or the investigator.

- Failure to satisfy the investigator of fitness to participate for any other reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [2] 0 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [3] 0 0
Women's and Children's Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Gold Coast
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Sha Tin
Country [2] 0 0
Israel
State/province [2] 0 0
Beer-Sheva
Country [3] 0 0
Israel
State/province [3] 0 0
Haifa
Country [4] 0 0
Israel
State/province [4] 0 0
Petach Tikvah
Country [5] 0 0
Lebanon
State/province [5] 0 0
Beirut
Country [6] 0 0
Malaysia
State/province [6] 0 0
Negeri Sembilan
Country [7] 0 0
Malaysia
State/province [7] 0 0
Sarawak
Country [8] 0 0
Malaysia
State/province [8] 0 0
Selangor
Country [9] 0 0
Malaysia
State/province [9] 0 0
Kuala Lumpur
Country [10] 0 0
Poland
State/province [10] 0 0
Greater Poland
Country [11] 0 0
Poland
State/province [11] 0 0
Kujawy-Pomerania
Country [12] 0 0
Poland
State/province [12] 0 0
Trzebnica County
Country [13] 0 0
Taiwan
State/province [13] 0 0
Kaohsiung
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taipei
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taoyuan
Country [16] 0 0
Turkey
State/province [16] 0 0
Adana Province
Country [17] 0 0
Turkey
State/province [17] 0 0
Eskisehir Province
Country [18] 0 0
Turkey
State/province [18] 0 0
Izmir Province
Country [19] 0 0
Turkey
State/province [19] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ark Biosciences Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Ark Biosciences Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to
evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect
of single and multiple dosing of AK0529 in infants hospitalized with RSV infection.
Trial website
https://clinicaltrials.gov/show/NCT02654171
Trial related presentations / publications
Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simões EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Ark Clinical Trial
Address 0 0
info@arkbiosciences.com
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications