Cytomegalovirus InfectionPhase 2NCT00223925
Maribavir for Prevention of CMV After Stem Cell Transplants
A Phase 2 study testing Maribavir in people with Cytomegalovirus Infection, run by Shire at 13 sites in United States.
Trial summary
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- Maribavir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 13 sitesUnited States
- Study dates
- 28 Oct 2004to 5 Apr 2006
- 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
- Allogeneic stem cell transplant recipient
- Recipient CMV seropositive
- Have transplant engraftment
- Able to swallow tablets
Who cannot join
- CMV organ disease
- HIV infection
- Use of other anti-CMV therapy post-transplant
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Tufts-New England Medical Center
Boston, Massachusetts
Baylor University Medical Center
Dallas, Texas
Wayne State Medical Center
Detroit, Michigan
City of Hope Medical Center
Duarte, California
Duke Medical Center
Durham, North Carolina
MD Anderson Cancer Center
Houston, Texas
UCLA Medical Center
Los Angeles, California
Loyola University
Maywood, Illinois
University of Minnesota
Minneapolis, Minnesota
Memorial Sloan-Kettering Cancer Center
New York, New York
University of Utah
Salt Lake City, Utah
Fred Hutchinson Cancer Research Center
Seattle, Washington
Washington University School of Medicine
St Louis, Missouri
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, and Prophylactic Anti-cytomegalovirus Activity of Maribavir in Recipients of Allogeneic Stem Cell Transplants
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.
- Conditions
- Cytomegalovirus Infection
- Being tested
- Maribavir, Placebo
- Keywords
- Stem cell transplantation, Allogeneic transplantation
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaribavirDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Maribavir (100 mg twice daily) | Experimental | Not described Receives: Drug: Maribavir |
| Maribavir (400 mg twice daily) | Experimental | Not described Receives: Drug: Maribavir |
| Maribavir (400 mg once daily) | Experimental | Not described Receives: Drug: Maribavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical safety as measured by the recording of treatment emergent adverse events
Measured: 13 weeks
Secondary outcomes (2)
Incidence of CMV disease
Measured: 13 weeks
Incidence of CMV infection
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study start28 Oct 2004
- Primary completion5 Apr 2006
- Study completion5 Apr 2006
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 Cytomegalovirus InfectionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223925
- Sponsor's protocol ID
- 1263-200
- Status last verified
- May 2021
- First submitted
- 13 Sep 2005
- Last updated
- 13 May 2021
- Results posted
- No
Publications
Winston DJ, Young JA, Pullarkat V, Papanicolaou GA, Vij R, Vance E, Alangaden GJ, Chemaly RF, Petersen F, Chao N, Klein J, Sprague K, Villano SA, Boeckh M. Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. Blood. 2008 Jun 1;111(11):5403-10. doi: 10.1182/blood-2007-11-121558. Epub 2008 Feb 19.
PubMed 18285548
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, and Prophylactic Anti-cytomegalovirus Activity of Maribavir in Recipients of Allogeneic Stem Cell Transplants
- ClinicalTrials.gov ID
- NCT00223925
- Acronym / sponsor ID
- 1263-200
- Conditions
- Cytomegalovirus Infection
- Keywords
- Stem cell transplantation, Allogeneic transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2004 (actual)
- Primary completion
- 5 Apr 2006 (actual)
- Study completion
- 5 Apr 2006 (actual)
- First posted
- 22 Sep 2005 (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.
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Maribavir (100 mg twice daily) | Experimental | Drug: Maribavir |
| Maribavir (400 mg twice daily) | Experimental | Drug: Maribavir |
| Maribavir (400 mg once daily) | Experimental | Drug: Maribavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Allogeneic stem cell transplant recipient
- Recipient CMV seropositive
- Have transplant engraftment
- Able to swallow tablets
Key exclusion criteria (3 listed)
- CMV organ disease
- HIV infection
- Use of other anti-CMV therapy post-transplant
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 |
|---|---|---|
| Maribavir | Drug | Maribavir (100 mg twice daily), Maribavir (400 mg once daily), Maribavir (400 mg twice daily) |
| Placebo | Drug | Placebo |
Primary outcome
Clinical safety as measured by the recording of treatment emergent adverse events
Time frame: 13 weeks
2 secondary outcomes
Incidence of CMV disease
Time frame: 13 weeks
Incidence of CMV infection
Time frame: 13 weeks
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 13 May 2021.
- Derived from this study: PubMed 18285548Winston DJ, Young JA, Pullarkat V, Papanicolaou GA, Vij R, Vance E, Alangaden GJ, Chemaly RF, Petersen F, Chao N, Klein J, Sprague K, Villano SA, Boeckh M. Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. Blood. 2008 Jun 1;111(11):5403-10. doi: 10.1182/blood-2007-11-121558. Epub 2008 Feb 19.
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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.
Study Director study director
Takeda
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maribavir in people with Cytomegalovirus Infection, run by Shire at 13 sites in United States.
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 3 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 13 May 2021. 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. 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?
Clinical safety as measured by the recording of treatment emergent adverse events (time frame: 13 weeks). 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 NCT00223925, 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 13 May 2021.