Viral Inhibition in Children for Treatment of RSV

NCT02654171 | Completed Phase 2 DMC

• 1 other identifier: AK0529-1003
• Study Type: interventional
• Target: 72
• Locations: 8 countries
• Sites: 28

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.

Conditions

RESPIRATORY SYNCYTIAL VIRUS INFECTIONS

Keywords

RSV; AK0529

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events during the study

  Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2)

• Subject withdrawals due to Adverse Events

  Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2)

Secondary Outcomes (8)

• Area under the plasma concentration-time curve from time 0 to infinity (AUC)

  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 )

• Maximum plasma concentration of AK0529 (Cmax)

  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 )

• Plasma concentration of AK0529 at 12 hours postdose (C12)

  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 )

• Apparent total body clearance (CL/F)

  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 )

• Apparent central compartment volume of distribution (Vc/F)

  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 )

Study Arms (2)

AK0529

EXPERIMENTAL

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

Drug: AK0529

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AK0529 DRUG

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.

AK0529

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead
• Ark Biosciences Pty Ltd.: collaborator

Study Sites (28)

Gold Coast University Hospital

Gold Coast, Queensland, Australia

Location

Lady Cilento Children's Hospital

South Brisbane, Queensland, 4101, Australia

Location

Women's and Children's Hospital

Adelaide, South Australia, Australia

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Soroka University Medical Center

Beersheba, Israel

Location

Ruth Rappaport Children's Hospital

Haifa, Israel

Location

Schneider Children's Medical Center

Petach Tikvah, Israel

Location

American University of Beirut Medical Center

Beirut, Lebanon

Location

Makassed General Hospital

Beirut, Lebanon

Location

Rafik Hariri University Hospital

Beirut, Lebanon

Location

Saint George Hospital University Medical Center

Beirut, Lebanon

Location

Hospital Tuanku Jaafar

Seremban, Negeri Sembilan, Malaysia

Location

Hospital Sibu

Sibu, Sarawak, Malaysia

Location

Hospital Selayang

Batu Caves, Selangor, Malaysia

Location

Hospital Tengku Ampuan Rahimah

Klang, Selangor, Malaysia

Location

University Malaya Medical Center

Kuala Lumpur, Malaysia

Location

Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Location

Nowy Szpital w Świeciu

Gmina Świecie, Kujawy-Pomerania, Poland

Location

Szpital im. Świętej Jadwigi Śląskiej w Trzebnicy

Trzebnica, Trzebnica County, Poland

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Cukurova University Balcali Hospital

Adana, Adana, Turkey (Türkiye)

Location

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, Eskişehir, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, İzmir, Turkey (Türkiye)

Location

Marmara University Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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, Simoes 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.

  PMID: 20399493 BACKGROUND

• Huang LM, Schibler A, Huang YC, Tai A, Chi H, Chieng CH, Wang JL, Goldbart A, Tang SP, Huang YC, George S, Alabaz D, Bentur L, Su SC, de Bruyne J, Karadag B, Gu F, Zou G, Toovey S, DeVincenzo JP, Wu JZ. Safety and efficacy of AK0529 in respiratory syncytial virus-infected infant patients: A phase 2 proof-of-concept trial. Influenza Other Respir Viruses. 2023 Jul 25;17(7):e13176. doi: 10.1111/irv.13176. eCollection 2023 Jul.

  PMID: 37502622 RESULT

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

ziresovir

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Ark Clinical Trial

  info@arkbiosciences.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 13, 2016
• Study Start: May 27, 2016
• Primary Completion: March 31, 2019
• Study Completion: April 9, 2019
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); LE (4); TW (5); AU (3); IL (3); MY (5); PL (3); TU (4)