Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01065935

Enrollment

Registered

2010-02-10

Start date

2010-02-28

Completion date

2012-05-31

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Keywords

ALN-RSV01, RSV, Respiratory Syncytial Virus

Brief summary

To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients

Interventions

DRUGALN-RSV01

Administered by nebulization once daily for 5 days

DRUGNormal Saline

Administered by nebulization once daily for 5 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Single or bilateral lung transplant recipients * Confirmed RSV infection * Greater than 90 days post current lung transplant * Rejection free for a minimum of 30 days

Exclusion criteria

* Known viral, bacterial, or fungal respiratory co-infection at the time of RSV diagnosis * Bronchiolitis obliterans syndrome (BOS) Grade 3 or any BOS with FEV1 that has not been stable for at least 3 months * Use of alemtuzumab within 9 months prior to screening, anti-thymocyte globulin (ATG) within 90 days of screening or prednisone or equivalent as maintenance therapy * Active treatment for acute graft rejection

Design outcomes

Primary

Measure	Time frame
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients	180 days after randomization

Secondary

Measure	Time frame
Proportion of patients with FEV1 >80% of pre-infection baseline value	90 and 180 days after randomization
RSV symptoms as measured by mean cumulative daily total symptom score	14 days after randomization
Viral load as measured by viral area under the curve (AUC)	6 days after randomization
All cause mortality	Throughout the study

Countries

Australia, Austria, Canada, France, Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026