A Study of ALS-008176 in Infants Hospitalized With RSV

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202356
• Other study ID #: ALS-8176-503
• Secondary ID: 2013-005104-33
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2014
• Est. completion date: February 15, 2018

Study information

• Verified date: April 2019
• Source: Alios Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• Male or female infant who is =1.0 to =12.0 months of age (inclusive), defined at the time of hospital admission, or <28 days of age (neonate cohort only). Note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an RSV related illness

Exclusion Criteria:

• Prematurity

• Receiving invasive endotracheal mechanical ventilation

• Poorly functioning gastrointestinal tract

• Anticipated to be discharged from the hospital in <24 hours from the time of randomization

• Prior exposure to palivizumab

Related Conditions & MeSH terms

• Infection
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• ALS-008176

• Placebo

Locations

Country	Name	City	State
Australia	The Canberra Hospital	Canberra
Australia	Monash Medical Center	Melbourne
Australia	Women's and Children's Hospital	North Adelaide
Australia	The Royal Children's Hospital Melbourne	Parkville
Australia	Princess Margaret Hospital	Perth
Canada	Canadian Centre for Vaccinology IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	The Children's Hospital Research Institute of Manitoba	Winnipeg	Manitoba
Chile	Hospital Dr. Exequiel Gonzalez Cortes	San Miguel	Santiago
Chile	Complejo Asistencial Dr Sotero del Rio	Santiago
Chile	Hospital Padre Hurtado	Santiago
Colombia	Fundacion Cardio Infantil Instituto de Cardiologia	Bogota
Colombia	Hospital Pablo Tobon Uribe	Medellin
France	CHU Pellegrin / Pneumologie pediatrique	Bordeaux
France	Hopital Necker	Paris
Japan	Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital	Asahikawa-shi	Hokkaido
Japan	Chiba Children's Hospital	Chiba-shi	Chiba
Japan	Tokyo Metropolitan Children's Medical Center	Fuchu-shi	Tokyo
Japan	Fukuoka Children's Hospital	Fukuoka
Japan	NHO Fukuoka Hospital	Fukuoka
Japan	NHO Fukuyama Medical Center	Fukuyama	Hiroshima
Japan	Hirosaki National Hospital	Hirosaki-shi	Aomori
Japan	NHO Kanazawa Medical Center	Kanazawa	Ishikawa
Japan	Kochi Health Sciences Center	Kochi
Japan	Nakano Children's Hospital	Osaka-city	Osaka
Japan	Ota Memorial Hospital	Ota	Gunma
Japan	Saitama Children's Medical Center	Saitama
Japan	National Center for Child Health and Development	Setagaya-ku	Tokyo
Japan	Gunma Children's Medical Center	Shibukawa-shi	Gunma
Japan	NHO Shikoku Medical Center for Children and Adults	Takamatsu	Kagawa
Japan	Okinawa Chubu Hospital	Urumi	Okinawa
Japan	National Hospital Organization Saitama National Hospital	Wako	Saitama
New Zealand	Christchurch Clinical Study Trust	Christchurch
New Zealand	Hawke's Bay Hospital	Hastings
New Zealand	Wellington Hospital	Wellington
Panama	Hospital Materno Infantil Jose Dominog de Obaldila	David	Chiriqui
Panama	Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"	Panama City
Panama	Hospital del Nino	Panama City
Romania	Institute for Mother and Child Care "Alfred Rusescu"	Bucharest
South Africa	2 Military Hospital	Cape Town
South Africa	Kingsbury Hospital	Cape Town
South Africa	Tygerberg Academic Hospital	Cape Town
Taiwan	Linkou Chang Gung Medical Hospital	Taipei
Taiwan	MacKay Memorial Hospital	Taipei
Thailand	Chulalongkorn University Department of Pediatrics	Bangkok
Thailand	Phramongkutklao Hospital Department of Pediatrics	Bangkok
Thailand	Siriraj Hospital, Mahidol University Department of Pediatrics	Bangkok
Thailand	Khon Kaen University Department of Pediatrics	Khon Kaen
United Kingdom	Birmingham Children's Hospital	Birmingham
United Kingdom	Royal Alexandra Children's Hospital	Brighton
United Kingdom	Bristol Royal Hospital for Children	Bristol	England
United Kingdom	Children's Hospital of Wales	Cardiff	Wales
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Alder Hey Children's Hospital	Liverpool	England
United Kingdom	St. George's University of London	London	England
United Kingdom	Royal Manchester Children's Hospital	Manchester
United Kingdom	Queens Medical Center	Nottingham
United Kingdom	University of Oxford	Oxford
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	England
United States	Children's of Alabama	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	The Research Institute at Nationwide Children's Hospital	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Texas Children's Hospital/Baylor College of Medicine	Houston	Texas
United States	The Children's Mercy	Kansas City	Missouri
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas
United States	Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach	Long Beach	California
United States	Children's Hospital/University of Tennessee	Memphis	Tennessee
United States	Children's Hospital of Orange County	Orange	California
United States	University of Rochester	Rochester	New York
United States	The University of Utah	Salt Lake City	Utah
United States	The University of California at San Diego	San Diego	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	LSU Health Sciences Center	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Alios Biopharma Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  Colombia,  France,  Japan,  New Zealand,  Panama,  Romania,  South Africa,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		Baseline through 6 days post-dose
Primary	Physical Examinations		Baseline through 6 days post-dose
Primary	Vital Signs		Baseline through 6 days post-dose
Primary	12-Lead ECGs		Baseline through 6 days post-dose
Primary	Clinical Laboratory Results		Baseline through 6 days post-dose
Secondary	RSV viral RNA concentrations in nasal aspirates		Baseline through 6 days post-dose
Secondary	Emergence of resistance	Changes in RSV polymerase that result in reduced sensitivity to study drug	Baseline through 6 days post-dose
Secondary	Pharmacokinetic parameters, including maximum and minimum drug concentrations		Baseline through 6 days post-dose
Secondary	Pharmacokinetic parameters, including time to maximum concentration and half-life		Baseline through 6 days post-dose
Secondary	Pharmacokinetic parameters, including area under concentration-time curves (AUCs)		Baseline through 6 days post-dose
Secondary	Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)		Baseline through 6 days post-dose