Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

NCT ID: NCT02254408

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-23
• Study Completion Date: 2017-07-14

Brief Summary

The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.

Conditions

Respiratory Syncytial Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Presatovir

Participants will receive presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.

Group Type: EXPERIMENTAL

Presatovir

Intervention Type: DRUG

Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube

Placebo

Participants will receive placebo on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets administered orally or via nasogastric tube

Interventions

Presatovir

Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube

Intervention Type: DRUG

Placebo

Tablets administered orally or via nasogastric tube

Intervention Type: DRUG

Other Intervention Names

GS-5806

Eligibility Criteria

Inclusion Criteria

• Received an autologous or allogeneic HCT using any conditioning regimen
• Documented to be RSV-positive as determined by local testing (eg, polymerase chain reaction, direct fluorescence antibody, respiratory viral panel assay, or culture) using an upper respiratory tract sample collected ≤ 6 days prior to Day 1
• New onset of at least 1 of the following respiratory symptoms for ≤ 7 days prior to Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of these chronic (associated with a previously existing diagnosis, eg, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms ≤ 7 days prior to Day 1
• No evidence of new abnormalities consistent with lower respiratory tract infection (LRTI) on a chest X-ray relative to the most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is not available or was not obtained during standard care < 48 hours prior to screening, a chest X-ray must be obtained for screening
• O2 saturation ≥ 92% on room air
• An informed consent document signed and dated by the participant or a legal guardian of the participant and the investigator or his/her designee
• A negative urine or serum pregnancy test is required for female participants (unless surgically sterile or greater than two years post-menopausal)
• Male and female participants of childbearing potential must agree to contraceptive requirements as described in the study protocol
• Willingness to complete necessary study procedures and have available a working telephone or email

Exclusion Criteria

Related to concomitant or previous medication use:

• Use of non-marketed (according to region) investigational agents within 30 days, OR use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccines after HCT

Related to medical history:

• Pregnant, breastfeeding, or lactating females
• Unable to tolerate nasal sampling required for this study, as determined by the investigator
• Known history of HIV/AIDS with a CD4 count <200 cells/μL within the last month
• History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent adherence to study activities

Related to medical condition at screening:

• Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus, or coronavirus) within 7 days prior to the screening visit, as determined by local testing (additional testing is not required)
• Clinically significant bacteremia or fungemia within 7 days prior to screening that has not been adequately treated, as determined by the investigator
• Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to screening that has not been adequately treated, as determined by the investigator
• Excessive nausea/vomiting at screening, as determined by the investigator, or an inability to swallow pills that precludes oral administration of the investigational medical product (for participants without an nasogastric tube in place)
• Any condition which, in the opinion of the investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints

Related to laboratory results:

• Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)
• Clinically significant aspartate aminotransferase/alanine aminotransferase, as determined by the investigator
• Clinically significant total bilirubin, as determined by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Mayo Clinic Arizona

Phoenix, Arizona, United States

City of Hope

Duarte, California, United States

UCLA David Geffen School of Medicine

Los Angeles, California, United States

Stanford University

Stanford, California, United States

Emory University

Atlanta, Georgia, United States

NorthSide Medical Center

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Loyola University

Maywood, Illinois, United States

John Hopkins

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Massachusetts Memorial Cancer Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering

New York, New York, United States

New York Presbyterian Hospital Cornell Medical Center

New York, New York, United States

Duke University

Durham, North Carolina, United States

University Hospital Case Medical

Cleveland, Ohio, United States

Oregon Health Sciences University

Portland, Oregon, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Texas Transplant Institute (SCRI)

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Fred Hutchison Cancer Research Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Westmead Hospital

Westmead, New South Wales, Australia

Royal Brisbane & Women's Hospital

Herston, , Australia

Royal Melbourne Hospital

Melbourne, , Australia

Hospital de Clínicas de Porto Alegre

Porto Alegre, , Brazil

Fundacao Faculdade Regional Medicina de Sao Jose do Rio Preto

São Paulo, , Brazil

Fundação Antonio Prudente - Hospital do Câncer AC Camargo

São Paulo, , Brazil

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Hospital Santa Marcelina

São Paulo, , Brazil

Hospital Universitario USP

São Paulo, , Brazil

Instituto Brasileiro de Controle do Câncer-IBCC

São Paulo, , Brazil

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Tom Baker Cancer Centre

Calgary, , Canada

CHU de Bordeaux

Bordeaux, , France

Hopital Saint-Louis, APHP

Paris, , France

Hopital Foch

Suresnes, , France

Institut Universitaire du Cancer Oncopole

Toulouse, , France

Universitatsklinikum Wurzburg

Würzburg, , Germany

Soroka Medical Center

Beersheba, , Israel

Rambam Medical Center

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

VUmc cancer center

Amsterdam, , Netherlands

Erasmus Medical Center (Rotterdam)

Rotterdam, , Netherlands

Singapore General Hospital

Singapore, , Singapore

UMC National University Health System

Singapore, , Singapore

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Seoul Saint Mary's Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Hospital universitario Virgen del Rocio

Seville, , Spain

Karolinska Institutet

Stockholm, , Sweden

University Clinic Basel

Basel, , Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation-LinKou Branch

Taoyuan District, , Taiwan

Leeds Teaching Hospitals Trust

Leeds, , United Kingdom

King's College Hospital

London, , United Kingdom

Countries

United States; Australia; Brazil; Canada; France; Germany; Israel; Netherlands; Singapore; South Korea; Spain; Sweden; Switzerland; Taiwan; United Kingdom

References

Chemaly RF, Dadwal SS, Bergeron A, Ljungman P, Kim YJ, Cheng GS, Pipavath SN, Limaye AP, Blanchard E, Winston DJ, Stiff PJ, Zuckerman T, Lachance S, Rahav G, Small CB, Mullane KM, Patron RL, Lee DG, Hirsch HH, Waghmare A, McKevitt M, Jordan R, Guo Y, German P, Porter DP, Gossage DL, Watkins TR, Marty FM, Chien JW, Boeckh M. A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial of Presatovir for the Treatment of Respiratory Syncytial Virus Upper Respiratory Tract Infection in Hematopoietic-Cell Transplant Recipients. Clin Infect Dis. 2020 Dec 31;71(11):2777-2786. doi: 10.1093/cid/ciz1166.

Reference Type: DERIVED

PMID: 31793991 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Original

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Document Type: Study Protocol: Amendment 1

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Document Type: Study Protocol: Amendment 2

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Document Type: Study Protocol: Amendment 3

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Document Type: Study Protocol: Amendment 5

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Document Type: Study Protocol: Amendment 6

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Document Type: Study Protocol: Amendment 7

View Document

Document Type: Statistical Analysis Plan

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Other Identifiers

2014-002474-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-218-0108

Identifier Type: -

Identifier Source: org_study_id