Lung transplant patients with Human respiratory syncytial virus (RSV) infection MedDRA version: 9.1 Level: LLT Classification code 10052200 Term: Respiratory syncytial virus infection NOS
Conditions
Interventions
Product Code: ALN-RSV01
Pharmaceutical Form: Nebuliser solution
Current Sponsor code: ALN-RSV01
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
P
Sponsors
Alnylam Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population is lung transplant patients infected with RSV. Key Inclusion Criteria include: - Adults =18 years old - Single or bilateral lung transplant recipients - Provide written informed consent - Greater than 90 days post current lung transplant - Rejection-free for a minimum of 1 month - Confirmed RSV infection by local laboratory’s testing methods and able to initiate study drug treatment within 3 days of positive RSV test. - If female, 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 3 months prior to Day -3 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Antimicrobial therapy for a known viral, bacterial, or fungal respiratory co-infection at the time of RSV diagnosis (Empiric therapy for suspected infection is permitted) 2. Bronchiolitis obliterans syndrome (BOS) Grade 3, or any stage BOS (see Appendix 4) with FEV1 that has not been stable for at least 3 months prior to onset of signs or symptoms of RSV infection. 3. Active treatment for acute graft rejection 4. Hospitalization that requires intubation or mechanical ventilation 5. Presence of tracheotomy 6. Past history of severe bronchospasm associated with aerosol drug use 7. Treatment with another investigational drug not approved in the US and/or EU, or participation in a clinical trial follow-up phase within 30 days prior to Screen (Day -3 to Day 0) 8. If female, the patient is pregnant, lactating or breast feeding 9. 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 MI, acute or chronic renal or liver failure) 10. Use of alemtuzumab (Campath®) within 9 months prior to Screen; anti-thymocyte globulin (ATG) or thymoglobulin within 3 months of Screen; or concurrent use of = 0.3 mg/kg/day prednisone or equivalent as maintenance therapy (see Appendix 3) 11. Known hypersensitivity to oligonucleotides 12. Previous enrollment in an ALN-RSV01 study 13. Is employed or is a first-degree relative of anyone employed by Alnylam, a participating clinical trial site, to any Contract Research Organization (CRO) involved in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - Treatment emergent AEs - Vital signs - Clinical laboratory and cytokine\CRP assessments - ECG parameters - Spirometry parameters - Pulse oximetry parameters - Physical exams (Complete and Directed);Main Objective: To assess the safety and tolerability of aerosolized ALN-RSV01 versus placebo administered once daily for 3 days in lung transplant patients infected with RSV;Secondary Objective: - Evaluate effects of ALN-RSV01 versus placebo on the clinical endpoints of RSV infection in lung transplant patients - Determine RSV infection characteristics by quantitative RT-PCR (qRT-PCR) analysis of nasal swab and sputum samples, including peak viral load, time to peak viral load, duration of viral shedding and viral AUC - Characterize plasma pharmacokinetics of aerosolized ALN-RSV01. | — |
Countries
Germany
Outcome results
None listed