Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
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| ClinicalTrials.gov Identifier: NCT01065935 |
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Recruitment Status :
Completed
First Posted : February 10, 2010
Last Update Posted : February 5, 2018
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Sponsor:
Alnylam Pharmaceuticals
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
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Brief Summary:
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiratory Syncytial Virus Infections | Drug: ALN-RSV01 Drug: Normal Saline | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 87 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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) |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | May 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: ALN-RSV01 |
Drug: ALN-RSV01
Administered by nebulization once daily for 5 days |
| Placebo Comparator: Normal saline |
Drug: Normal Saline
Administered by nebulization once daily for 5 days |
Primary Outcome Measures :
- The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients [ Time Frame: 180 days after randomization ]
Secondary Outcome Measures :
- Proportion of patients with FEV1 >80% of pre-infection baseline value [ Time Frame: 90 and 180 days after randomization ]
- RSV symptoms as measured by mean cumulative daily total symptom score [ Time Frame: 14 days after randomization ]
- Viral load as measured by viral area under the curve (AUC) [ Time Frame: 6 days after randomization ]
- All cause mortality [ Time Frame: Throughout the study ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065935
Locations
| United States, Arizona | |
| Clinical Site | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Clinical Site | |
| Los Angeles, California, United States, 90033 | |
| United States, Colorado | |
| Clinical Site | |
| Denver, Colorado, United States, 80202 | |
| United States, Florida | |
| Clinical Site | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Clinical Site | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Clinical Site | |
| Chicago, Illinois, United States, 60153 | |
| Clinical Site | |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Clinical Site | |
| Boston, Massachusetts, United States, 02114 | |
| Clinical Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Clinical Site | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Missouri | |
| Clinical Site | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Clinical Site | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Clinical Site | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Clinical Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Clinical Site | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Clinical Site | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Clinical Site | |
| Dallas, Texas, United States, 75390 | |
| Clinical Site | |
| Houston, Texas, United States, 77030 | |
| Australia, New South Wales | |
| Clinical Site | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Australia, South Australia | |
| Clinical Site | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Clinical Site | |
| Melbourne, Victoria, Australia, 3004 | |
| Australia, Western Australia | |
| Clinical Site | |
| Perth, Western Australia, Australia, 6001 | |
| Austria | |
| Clinical Site | |
| Vienna, Austria, 1090 | |
| Canada, Alberta | |
| Clinical Site | |
| Edmonton, Alberta, Canada, T6G 2E1 | |
| Canada, Ontario | |
| Clinical Site | |
| Toronto, Ontario, Canada, M5G 2N2 | |
| France | |
| Clinical Site | |
| Paris, France, 75908 | |
| Clinical Site | |
| Strasbourg Cedex, France, 67091 | |
| Germany | |
| Clinical Site | |
| Berlin, Germany, 10117 | |
| Clinical Site | |
| Essen, Germany, 45239 | |
| Clinical Site | |
| Hamburg, Germany, 20246 | |
| Clinical Site | |
| Hannover, Germany, 30625 | |
| Clinical Site | |
| Homburg/Saar, Germany, 66421 | |
| Clinical Site | |
| Leipzig, Germany, 04103 | |
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
| Principal Investigator: | 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 |
| Responsible Party: | Alnylam Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01065935 |
| Other Study ID Numbers: |
ALN-RSV01-109 |
| First Posted: | February 10, 2010 Key Record Dates |
| Last Update Posted: | February 5, 2018 |
| Last Verified: | January 2018 |
Keywords provided by Alnylam Pharmaceuticals:
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ALN-RSV01 RSV Respiratory Syncytial Virus |
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections Virus Diseases Infections Pneumovirus Infections |
Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |