Respiratory Syncytial Virus InfectionsPhase 2NCT01065935
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
A Phase 2 study testing ALN-RSV01 and Normal Saline in people with Respiratory Syncytial Virus Infections, run by Alnylam Pharmaceuticals at 33 sites in 6 countries.
Trial summary
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- ALN-RSV01 and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 33 sitesin 6 countries
- Study dates
- Feb 2010to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States18 sites
Clinical Site
Ann Arbor, Michigan, 48109
Clinical Site
Atlanta, Georgia, 30322
Clinical Site
Boston, Massachusetts, 02114
Clinical Site
Boston, Massachusetts, 02115
Clinical Site
Chicago, Illinois, 60153
Clinical Site
Chicago, Illinois, 60637
Clinical Site
Cleveland, Ohio, 44195
Clinical Site
Dallas, Texas, 75390
Clinical Site
Denver, Colorado, 80202
Clinical Site
Houston, Texas, 77030
Clinical Site
Los Angeles, California, 90033
Clinical Site
Nashville, Tennessee, 37232
Clinical Site
New York, New York, 10032
Clinical Site
Philadelphia, Pennsylvania, 19104
Clinical Site
Phoenix, Arizona, 85013
Clinical Site
Pittsburgh, Pennsylvania, 15213
Clinical Site
St Louis, Missouri, 63110
Clinical Site
Tampa, Florida, 33606
Germany6 sites
Clinical Site
Berlin, 10117
Clinical Site
Essen, 45239
Clinical Site
Hamburg, 20246
Clinical Site
Hanover, 30625
Clinical Site
Homburg/Saar, 66421
Clinical Site
Leipzig, 04103
Australia4 sites
Clinical Site
Adelaide, South Australia, 5000
Clinical Site
Darlinghurst, New South Wales, 2010
Clinical Site
Melbourne, Victoria, 3004
Clinical Site
Perth, Western Australia, 6001
Canada2 sites
Clinical Site
Edmonton, Alberta, T6G 2E1
Clinical Site
Toronto, Ontario, M5G 2N2
About this study
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)
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- ALN-RSV01, Normal Saline
- Keywords
- ALN-RSV01, RSV, Respiratory Syncytial Virus
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-RSV01Drug
Administered by nebulization once daily for 5 days
Normal SalineDrug
Administered by nebulization once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| ALN-RSV01 | Active comparator | Not described Receives: Drug: ALN-RSV01 |
| Normal saline | Placebo comparator | Not described Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
Measured: 180 days after randomization
Secondary outcomes (4)
Proportion of patients with FEV1 >80% of pre-infection baseline value
Measured: 90 and 180 days after randomization
RSV symptoms as measured by mean cumulative daily total symptom score
Measured: 14 days after randomization
Viral load as measured by viral area under the curve (AUC)
Measured: 6 days after randomization
All cause mortality
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Zamora, MD, Principal investigator, University of Colorado, DenverAlan Glanville, MB BS MD Syd, FRACP, Principal investigator, St. Vincents Hospital NSW W AustraliaJens T Gottlieb, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065935
- Sponsor's protocol ID
- ALN-RSV01-109
- Status last verified
- Jan 2018
- First submitted
- 5 Feb 2010
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01065935
- Acronym / sponsor ID
- ALN-RSV01-109
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- ALN-RSV01, RSV, Respiratory Syncytial Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALN-RSV01 | Active comparator | Drug: ALN-RSV01 |
| Normal saline | Placebo comparator | Drug: Normal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALN-RSV01Administered by nebulization once daily for 5 days | Drug | ALN-RSV01 |
| Normal SalineAdministered by nebulization once daily for 5 days | Drug | Normal saline |
Primary outcome
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
Time frame: 180 days after randomization
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Zamora, MD principal investigator
University of Colorado, Denver
Alan Glanville, MB BS MD Syd, FRACP principal investigator
St. Vincents Hospital NSW W Australia
Jens T Gottlieb, MD principal investigator
Hannover Medical School
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALN-RSV01 and Normal Saline in people with Respiratory Syncytial Virus Infections, run by Alnylam Pharmaceuticals at 33 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Australia, Canada, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients (time frame: 180 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.