Respiratory Syncytial Virus InfectionsPhase 2NCT00658086
Phase 2 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 13 sites in 2 countries.
Trial summary
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 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
- 24 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2008to Jun 2009
- 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 1 month
Who cannot join
- Antimicrobial therapy for known viral, bacterial, or fungal respiratory co-infection at the time of diagnosis
- Bronchiolitis obliterans syndrome (BOS) Grade 3 or any state 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) or thymoglobulin within 3 months of screening: concurrent use of >= 0.3 mg/kg/day prednisone or equivalent as maintenance therapy
- active treament for acute graft rejection
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Clinical Site
Atlanta, Georgia
Clinical Site
Boston, Massachusetts
Clinical Site
Chicago, Illinois
Clinical Site
Cleveland, Ohio, 44195
Clinical Site
Denver, Colorado, 80262
Clinical Site
Gainesville, Florida
Clinical Site
Minneapolis, Minnesota, 55455
Clinical Site
Nashville, Tennessee, 37232
Clinical Site
San Diego, California, 92103
Clinical Site
San Francisco, California, 94143
Australia3 sites
Clinical Site
Brisbane, Queensland
Clinical Site
Perth, Western Australia
Clinical Site
Sydney, New South Wales
About this study
Official title: A Multi-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- ALN-RSV01, normal saline
- Keywords
- ALN-RSV01, 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 3 days
normal salineDrug
administered by nebulization once daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ALN-RSV01 Receives: Drug: ALN-RSV01 |
| 2 | Placebo comparator | Normal saline Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
Measured: Day 30
Secondary outcomes (1)
Evaluate effects of ALN-RSV01 on clinical and virologic endpoints
Measured: Throughout Trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Zamora, MD, Principal investigator, University of Colorado Health Science CenterAllan Glanville, MB BS MD Syd, FRACP, Principal investigator, St. Vincent's Hospital NSW Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658086
- Sponsor's protocol ID
- ALN-RSV01-106
- Status last verified
- Jan 2018
- First submitted
- 9 Apr 2008
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Zamora MR, Budev M, Rolfe M, Gottlieb J, Humar A, Devincenzo J, Vaishnaw A, Cehelsky J, Albert G, Nochur S, Gollob JA, Glanville AR. RNA interference therapy in lung transplant patients infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2011 Feb 15;183(4):531-8. doi: 10.1164/rccm.201003-0422OC. Epub 2010 Sep 17.
PubMed 20851929
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
- ClinicalTrials.gov ID
- NCT00658086
- Acronym / sponsor ID
- ALN-RSV01-106
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- ALN-RSV01, Respiratory Syncytial Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Apr 2008 (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 safety,tolerability and antiviral activitity of ALN-RSV01 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 |
|---|---|---|
| 1 | Active comparator | Drug: ALN-RSV01ALN-RSV01 |
| 2 | Placebo comparator | Drug: normal salineNormal 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 1 month
Key exclusion criteria (4 listed)
- Antimicrobial therapy for known viral, bacterial, or fungal respiratory co-infection at the time of diagnosis
- Bronchiolitis obliterans syndrome (BOS) Grade 3 or any state 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) or thymoglobulin within 3 months of screening: concurrent use of >= 0.3 mg/kg/day prednisone or equivalent as maintenance therapy
- active treament 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 3 days | Drug | 1 |
| normal salineadministered by nebulization once daily for 3 days | Drug | 2 |
Primary outcome
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
Time frame: Day 30
1 secondary outcome
Evaluate effects of ALN-RSV01 on clinical and virologic endpoints
Time frame: Throughout Trial
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 29 Jan 2018.
- Derived from this study: PubMed 20851929Zamora MR, Budev M, Rolfe M, Gottlieb J, Humar A, Devincenzo J, Vaishnaw A, Cehelsky J, Albert G, Nochur S, Gollob JA, Glanville AR. RNA interference therapy in lung transplant patients infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2011 Feb 15;183(4):531-8. doi: 10.1164/rccm.201003-0422OC. Epub 2010 Sep 17.
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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 Health Science Center
Allan Glanville, MB BS MD Syd, FRACP principal investigator
St. Vincent's Hospital NSW Australia
13 sites in 2 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 13 sites in 2 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia. 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?
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00658086, which also lists 1 linked publication.
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 29 Jan 2018.