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

NCT01065935 | Completed Phase 2 DMC

• 1 other identifier: ALN-RSV01-109
• Study Type: interventional
• Target: 87
• Locations: 5 countries
• Sites: 32

Brief Summary

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

Conditions

Respiratory Syncytial Virus Infections

Keywords

ALN-RSV01; RSV; Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (1)

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

  180 days after randomization

Secondary Outcomes (4)

• 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

Study Arms (2)

ALN-RSV01

ACTIVE COMPARATOR

Drug: ALN-RSV01

Normal saline

PLACEBO COMPARATOR

Drug: Normal Saline

Interventions

ALN-RSV01 DRUG

Administered by nebulization once daily for 5 days

ALN-RSV01

Normal Saline DRUG

Administered by nebulization once daily for 5 days

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alnylam Pharmaceuticals: lead

Study Sites (33)

Clinical Site

Phoenix, Arizona, 85013, United States

Location

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Los Angeles, California, 90033, United States

Location

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Denver, Colorado, 80202, United States

Location

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Tampa, Florida, 33606, United States

Location

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Atlanta, Georgia, 30322, United States

Location

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Chicago, Illinois, 60153, United States

Location

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Chicago, Illinois, 60637, United States

Location

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Boston, Massachusetts, 02114, United States

Location

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Boston, Massachusetts, 02115, United States

Location

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Ann Arbor, Michigan, 48109, United States

Location

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St Louis, Missouri, 63110, United States

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New York, New York, 10032, United States

Location

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Cleveland, Ohio, 44195, United States

Location

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Philadelphia, Pennsylvania, 19104, United States

Location

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Pittsburgh, Pennsylvania, 15213, United States

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Nashville, Tennessee, 37232, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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Darlinghurst, New South Wales, 2010, Australia

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Adelaide, South Australia, 5000, Australia

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Melbourne, Victoria, 3004, Australia

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Perth, Western Australia, 6001, Australia

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Vienna, 1090, Austria

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Edmonton, Alberta, T6G 2E1, Canada

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Toronto, Ontario, M5G 2N2, Canada

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Paris, 75908, France

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Strasbourg, 67091, France

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Berlin, 10117, Germany

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Essen, 45239, Germany

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Hamburg, 20246, Germany

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Hanover, 30625, Germany

Location

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Homburg/Saar, 66421, Germany

Location

Clinical Site

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Martin Zamora, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Alan Glanville, MB BS MD Syd, FRACP

  St. Vincents Hospital NSW W Australia

  PRINCIPAL INVESTIGATOR

• Jens T Gottlieb, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 10, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

AU (4); US (18); CA (2); FR (2); DE (6)