A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.

NCT ID: NCT04225897

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-13
• Study Completion Date: 2022-12-05

Brief Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it.

This study will be conducted in 3 parts:

In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B.

The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo.

To participate in this study participants must meet the following criteria:

1. Age 1 month to 36 months

2. Weight ≥ 3.5 kg

3. Diagnosis of LRTI

4. Diagnosis of RSV

5. Hospitalization due to RSV LRTI

Detailed Description

This is a multicentre, 3-part study to evaluate safety, tolerability, PK, PD, and antiviral effect of single and multiple dosing of RV521 in infants hospitalised due to RSV LRTI.

The clinical study consists of 3 parts, the third part (Part C) is optional:

• Part A is an open-label, multicentre, single dose study in infants hospitalised with RSV LRTI (Cohorts 1 & 2)
• Part B is a randomised, double-blind, placebo-controlled, multicentre multiple dose study in infants hospitalised with RSV LRTI (Cohorts 3, 4 & 5)
• Part C is a randomised 1:1, double-blind, placebo-controlled, multicentre, multiple-dose study in infants hospitalised with RSV LRTI I The number of subjects enrolled in Parts A and B of the study will depend on the safety and PK data from the group of subjects enrolled in specified age cohorts and the subsequent recommendation of the Data Safety Monitoring Committee (DSMC).

The DSMC may recommend a dose adjustment (either a reduction or an escalation) and/or regimen adjustment (Part B only) for subsequent subjects because of the observation of an unexpected safety/tolerability profile and/or differences between the observed and predicted exposure resulting from a specified dose of RV521.

Conditions

Respiratory Syncytial Virus (RSV); Lower Resp Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RV521

sisunatovir is formulated as a dry powder blend of RV521 drug substance with mannitol as excipient. The RV521 dry powder blend will be supplied in capsules containing 10, 20, or 50 mg RV521. The Investigational Medicinal Product (IMP) will be dispersed in a defined volume of suspending diluent prior to oral administration on a mg/kg basis. Instructions for opening the capsule(s) and dispersing the contents in a fixed volume of suspending diluent prior to administration will be provided in the Pharmacy Manual.

The proposed dosing regimen for Part A is a single open label dose of RV521. Part B and C is RV521 or placebo administered BID, 12 hours apart, for a period of 5 consecutive days with a total of 10 doses. However, this is subject to the recommendation of the DSMC.

Group Type: EXPERIMENTAL

RV521

Intervention Type: DRUG

RV521 is an RSV F protein inhibitor administered orally

Placebo

The placebo capsules administered in Part B and C will contain mannitol and microcrystalline cellulose (vehicle). The placebo dry powder will be dispersed in suspending diluent and given orally BID. Instructions for opening the capsule(s) and dispersing the contents in a fixed volume of suspending diluent prior to administration will be provided in the Pharmacy Manual.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

vehicle administered orally

Interventions

RV521

RV521 is an RSV F protein inhibitor administered orally

Intervention Type: DRUG

Placebo

vehicle administered orally

Intervention Type: DRUG

Other Intervention Names

sisunatovir

Eligibility Criteria

Inclusion Criteria

1. Male or female ≥ 1 month and ≤ 36 months of age

2. Weight ≥ 3.5 kg

3. Clinical diagnosis of LRTI

4. A positive RSV diagnostic test

5. Hospitalised because of RSV LRTI

6. Symptoms of LRTI must be present for no more than 1 week (Part B) and no more than 5 days (Part C) before the Screening Visit

7. Expected to remain in hospital for a minimum of 3 days

8. The parent(s)/legal guardian(s) of the subject have provided written informed consent for the subject to participate and are able and willing to comply with the study protocol

Exclusion Criteria

1. Premature (gestational age less than 37 weeks) AND <1 year of post-natal age

2. Known to have significant comorbidities that would limit the ability to administer study drug or evaluate the safety or clinical response to study drug.

3. Any clinically significant ECG abnormalities.

4. Known to be immunocompromised.

5. High risk of having developing asthma.

6. Suspected of having a clinically significant bacterial infection.

7. History of renal failure.

8. Clinical evidence of hepatic decompensation

9. History of epilepsy or seizures, including febrile seizures

10. Allergy to test medication or constituents

11. Has received 1 or more doses of palivizumab at any time before Screening or received treatment with antiviral therapy for RSV (eg, ribavirin or intravenous [IV] immunoglobulin) within 3 months before the Screening Visit.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Hospital Interzonal General de Agudos "Dr. José Penna"

Bahía Blanca, Buenos Aires, Argentina

Hospital Italiano Regional Del Sur

Bahía Blanca, Buenos Aires, Argentina

Hospital General de Ninos Pedro de Elizalde

Buenos Aires, Buenos Aires F.D., Argentina

Hospital de ninos "Ricardo Gutierrez"

Calgary, Alberta, Canada

Hospital Base San Jose Osorno

Osorno, Los Lagos Region, Chile

Hospital de Ninos Dr. Roberto del Rio

Santiago, Santiago Metropolitan, Chile

Corporacion Gihema

San José, , Costa Rica

Hospital Clinica Biblica

San José, , Costa Rica

Hospital Metropolitano, Sede San Jose

San José, , Costa Rica

lnstituto de lnvestigacion en Ciencias Medicas(IICIMED)

San José, , Costa Rica

Policlinico San Bosco, Consultorio de Pediatria, Dr. Arturo Solis Moya

San José, , Costa Rica

Semmelweis Egyetem 11.sz. Gyermeklinika

Budapest, , Hungary

Eszak-Kozep-budai Centrum,Uj Szent Janos Korhaz es Szakrendelo,Gyermekosztaly

Budapest, , Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Soroka University Medical Center

Beersheba, , Israel

Rambam Health Care Campus

Haifa, , Israel

Schneider Children's Medical Center of Israel

Petach Tikava, , Israel

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Hospital Taiping

Taiping, Perak, Malaysia

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, Malaysia

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Hospital Sibu

Sibu, Sarawak, Malaysia

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Terengganu, Malaysia

Hospital Seri Manjung

Parek, , Malaysia

Capital and Coast DHB, Wellington Hospital

Riddiford Street, Wellington Region, New Zealand

Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"

Panama City, , Panama

Hospital del Nino Dr. Jose Renan Esquivel

Panama City, , Panama

Hospital Materno Infantil Jose Domingo de Obaldia

Panama City, , Panama

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, , Poland

lnstytut Centrum Zdrowia Matki Polki Klinika Pediatrii, Immunologii i Nefrologii

Lodz, , Poland

Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie Oddzial Kliniczny Pediatrii

Warsaw, , Poland

Seoul National University Children's Hospital

Seoul, , South Korea

Department of Pediatrics, SoonchunHyang University Seoul Hospital

Seoul, , South Korea

Hospital Universitario Sant Joan de Deu

Espluges de Llobregat, Barcelona, Spain

Fundacion Hospital de Nens

Barcelona, , Spain

Clinica Universidad de Navarra

Madrid, , Spain

Hospital Clinico de San carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario de la Paz ,Pediatric Deparment

Madrid, , Spain

Hospital Universitario La Paz Servicio de Farmacia. Planta baja Edificio Norte

Madrid, , Spain

Clinica Universidad de Navarra

Pamplona, , Spain

Complejo Hospitalario de Santiago

Santiago de Compostela, , Spain

Hsinchu Mackay Memorial Hospital

Hsinchu, , Taiwan

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, , Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Chi Mei Medical Center

Tainan City, , Taiwan

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

The Pharmacy Unit Ground Floor, OPD Building Faculty of Madicine,

Bangkoknoi, Bangkok, Thailand

Chula Clinical Research Center, Faculty of Medicine

Patumwan, Bangkok, Thailand

King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

Bangkok, , Thailand

QueenSirikit National Institute of Child Health {QSNICH}

Bangkok, , Thailand

Maharaj Nakorn Chiang Mai Hospital,Faculty of Medicine, Chiang Mai University

Chiang Mai, , Thailand

Chiangrai Prachanukroh Hospital

Chiangrai, , Thailand

Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Naresuan University Hospital ,Faculty of Medicine, Naresuan University

Phitsanulok, , Thailand

Alder Hey Children's NHS Foundation Trust Institute in the Park

Liverpool, , United Kingdom

Guy's and St Thomas' NHS Foundation Trust Evelina London Children's Hospital Westminster

London, , United Kingdom

Imperial College Healthcare NHS Trust St Mary's Hospital

London, , United Kingdom

University Hospital Southampton NHS Foundation Trust NIHR Clinical Research Facility ,Mailpoint 218,

Southampton, , United Kingdom

Countries

Argentina; Canada; Chile; Costa Rica; Hungary; Israel; Malaysia; New Zealand; Panama; Poland; South Korea; Spain; Taiwan; Thailand; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=REVC003

To obtain contact information for a study center near you, click here.

Other Identifiers

C5241003

Identifier Type: OTHER

Identifier Source: secondary_id

REVC003

Identifier Type: -

Identifier Source: org_study_id