Lung transplant patients with respiratory syncytial virus (RSV) infection MedDRA version: 13.1 Level: LLT Classification code 10052200 Term: Respiratory syncytial virus infection NOS System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: ALN-RSV01
Product Code: ALN-RSV01
Pharmaceutical Form: Nebuliser solution
Current Sponsor code: ALN-RSV01
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conc
Sponsors
Alnylam Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Adults = 18 years old. •Single or bilateral lung transplant recipients. Note that subjects who required a bilateral or ipsilateral lung transplant to be redone are eligible for enrollment. •Provide written informed consent. •Greater than 90 days post current lung transplant. •Rejection-free for a minimum of 30 days. •Confirmed RSV infection by either the site’s local laboratory method or by a central laboratory selected by the Sponsor. •Able to initiate study drug treatment within 48 hours of positive RSV test. •If a female of child-bearing potential, agrees to use appropriate double barrier contraception for a period of 30 days after the last dose of study medication. If the subject is using oral, implanted or injectable contraception, she must have been using them for at least 90 days prior to Day -2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 102 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: •Candidates for lung re-transplant (single or double). •Known acute viral, bacterial, or fungal respiratory co-infection at the time of RSV diagnosis. Empiric therapy for suspected acute infection is permitted, as is chronic suppressive therapy in the case of latent infections, such as atypical mycobacterial infections, and chronic immunoprophylaxis for infections, such as Pneumocystis carinii pneumonia (PCP) or cytomegalovirus (CMV). •BOS Grade 3 or any stage BOS with Forced Expiratory Volume in one second that has not been stable for at least 90 days prior to onset of signs or symptoms of RSV infection. •Active treatment for acute graft rejection. •Hospitalization that requires intubation or mechanical ventilation. •Presence of tracheotomy. •Past history of severe bronchospasm associated with aerosol drug use. •Treatment with another investigational drug not approved in the US, Canada, Australia, and/or EU, or participation in a clinical trial follow-up phase within 30 days prior to Screen. •If female, the patient is pregnant, lactating or breast feeding. •Any other disease or condition, which in the Investigator’s medical opinion would preclude the patient’s participation in a clinical trial (e.g., recent myocardial infarction [MI], acute or chronic renal or liver failure). •Use of alemtuzumab (Campath®) within 9 months prior to Screen; anti-thymocyte globulin (ATG) or Thymoglobulin within 90 days of Screen; or concurrent use of greater than or equal to 0.3 mg/kg/day prednisone or equivalent as maintenance therapy (see Appendix 3 of the protocol). •Known hypersensitivity to oligonucleotides. •Is employed or is a first-degree relative of anyone employed by Alnylam, a participating clinical trial site, a participating clinical trial site, or any CRO involved in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the effect of aerosolized ALN-RSV01 on the incidence of new or progressive bronchiolitis obliterans syndrome (BOS) at Day 180 in lung transplant patients infected with RSV.;Secondary Objective: •Assess the safety and tolerability of aerosolized ALN-RSV01 administered once daily for 5 days in lung transplant patients infected with RSV. •Evaluate the incidence of new or progressive BOS at Day 90. •Evaluate the proportion of patients with Forced Expiratory Volume in one second greater than 80% of pre-infection baseline value at Days 90 and 180. •Evaluate patient symptom scores. •Evaluate the duration of the initial hospitalization for the RSV infection. •Evaluate the following through Day 180: •Survival, the need for intubation or other medical interventions, number of days on ventilator, and acute lung rejection. •Viral endpoints as measured by nasal swab and oropharyngeal wash samples by qRT-PCR and on oropharyngeal wash samples by quantitative culture on Days 0-6. ;Primary end point(s): The primary efficacy endpoint is the incidence of new or progressive BOS at Day 180. | — |
Countries
Australia, Austria, Canada, France, Germany, United States
Contacts
Public ContactRegulatory Submissions
Medpace Germany GmbH
Outcome results
None listed