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Completed

NCT Number: NCT01065935

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

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

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Site, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALN-RSV01

Drug

Administered by nebulization once daily for 5 days

normal saline

Drug

Administered by nebulization once daily for 5 days

Primary outcomes

  1. The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients

    Time frame: 180 days after randomization

Secondary outcomes

  1. Proportion of patients with FEV1 >80% of pre-infection baseline value

    Time frame: 90 and 180 days after randomization

  2. RSV symptoms as measured by mean cumulative daily total symptom score

    Time frame: 14 days after randomization

  3. Viral load as measured by viral area under the curve (AUC)

    Time frame: 6 days after randomization

  4. All cause mortality

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

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)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 10, 2010
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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