Cytomegalovirus InfectionsPhase 3NCT00241345
Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
A Phase 3 study testing Valganciclovir and Ganciclovir in people with Cytomegalovirus Infections, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have undergone bone marrow or peripheral blood stem cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- Valganciclovir and Ganciclovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Dec 2007
- Phase
- Phase 3
- 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
- Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center.
- An initial episode of CMV viremia.
- At the time of randomization:
- ANC greater than or equal to 1000
- Age greater than or equal to 18
- Adequate renal function with creatinine clearance greater than 10 ml/min
- Total bilirubin less than or equal to 3.0
Who cannot join
- Current GI graft versus host disease grade III-IV
- Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR
- Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days
- Pregnant or nursing female patient
- Known hypersensitivity to ganciclovir
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Randomized Trial of Preemptive Treatment With Oral Valganciclovir Compared With IV Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have undergone bone marrow or peripheral blood stem cell transplant.
Read the detailed description
- To study the effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.
- To determine the incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.
- To compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.
- To determine the toxicity profile of valganciclovir.
- To screen for mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment.
- To determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir.
- Conditions
- Cytomegalovirus Infections
- Being tested
- Valganciclovir, Ganciclovir
- Keywords
- post transplant, Any patient receiving an allogeneic bone marrow or peripheral blood stem cell transplant at Washington University Medical Center
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
GanciclovirDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | IV ganciclovir (5mg/kg every 12 hours for 7 days followed by 5mg/kg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 5mg/kg every 24 hours for a total of 21 total days of therapy. If CMV viral load >5000/ml but less than index viral load after 14 days then 5mg/kg every 24 hours for a total of 28 total days of therapy. If CMV viral load >= index viral load after 14 days then 5mg/kg every 12 hours for 7 days. If repeat CMV viral load is <= the previous CMV viral load then 5mg/kg every 12 hours for an additional 7 days. Receives: Drug: Ganciclovir |
| Group B | Experimental | PO valganciclovir (900 mg every 12 hours for 7 days followed by 900 mg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 900 mg every day until 21 total days of therapy. If CMV viral load >5000 copies/ml after 14 days but less than the index viral load then 900 mg every day until 28 total days of therapy. If CMV viral load >= the index viral load 900 mg every 12 hours for 7 days, if CMV viral load <= to previous viral load then 900 mg every 12 hours for another 7 days. Receives: Drug: Valganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
If preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing CMV viremia as determined by quantitative CMV PCR assay in patients who have undergone allogeneic bone marrow or peripheral stem cell transplant.
Clearance of CMV viremia will be defined as CMV viral load less than 5,000 copies/ml of whole blood.
Measured: 4 weeks from start of therapy
Secondary outcomes (6)
Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.
Measured: 6 months
Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.
Measured: 6 months
Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.
Measured: 6 months
Toxicity profile of valganciclovir
Measured: 6 months
Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment
Measured: 14 days
Determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startJun 2004
- Primary completionNov 2007
- Study completionDec 2007
Why it stopped: Due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Vij, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241345
- Sponsor's protocol ID
- 04-0274
- Status last verified
- Jul 2013
- First submitted
- 17 Oct 2005
- Last updated
- 23 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Preemptive Treatment With Oral Valganciclovir Compared With IV Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00241345
- Acronym / sponsor ID
- 04-0274
- Conditions
- Cytomegalovirus Infections
- Keywords
- post transplant, Any patient receiving an allogeneic bone marrow or peripheral blood stem cell transplant at Washington University Medical Center
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low accrual
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Oct 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.
The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have undergone bone marrow or peripheral blood stem cell transplant.
Detailed description
- To study the effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.
- To determine the incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.
- To compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.
- To determine the toxicity profile of valganciclovir.
- To screen for mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment.
- To determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: GanciclovirIV ganciclovir (5mg/kg every 12 hours for 7 days followed by 5mg/kg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 5mg/kg every 24 hours for a total of 21 total days of therapy. If CMV viral load >5000/ml but less than index viral load after 14 days then 5mg/kg every 24 hours for a total of 28 total days of therapy. If CMV viral load >= index viral load after 14 days then 5mg/kg every 12 hours for 7 days. If repeat CMV viral load is <= the previous CMV viral load then 5mg/kg every 12 hours for an additional 7 days. |
| Group B | Experimental | Drug: ValganciclovirPO valganciclovir (900 mg every 12 hours for 7 days followed by 900 mg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 900 mg every day until 21 total days of therapy. If CMV viral load >5000 copies/ml after 14 days but less than the index viral load then 900 mg every day until 28 total days of therapy. If CMV viral load >= the index viral load 900 mg every 12 hours for 7 days, if CMV viral load <= to previous viral load then 900 mg every 12 hours for another 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center.
- An initial episode of CMV viremia.
- At the time of randomization:
Key exclusion criteria (5 listed)
- Current GI graft versus host disease grade III-IV
- Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR
- Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days
- Pregnant or nursing female patient
- Known hypersensitivity to ganciclovir
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 |
|---|---|---|
| Valganciclovir | Drug | Group B |
| Ganciclovir | Drug | Group A |
Primary outcome
If preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing CMV viremia as determined by quantitative CMV PCR assay in patients who have undergone allogeneic bone marrow or peripheral stem cell transplant.
Time frame: 4 weeks from start of therapy
Clearance of CMV viremia will be defined as CMV viral load less than 5,000 copies/ml of whole blood.
6 secondary outcomes
Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.
Time frame: 6 months
Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.
Time frame: 6 months
Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.
Time frame: 6 months
Toxicity profile of valganciclovir
Time frame: 6 months
Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment
Time frame: 14 days
Determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Due to low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Ravi Vij, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valganciclovir and Ganciclovir in people with Cytomegalovirus Infections, run by Washington University School of Medicine at 1 site 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Due to low accrual). Results are not available in the source record.
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?
If preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing CMV viremia as determined by quantitative CMV PCR assay in patients who have undergone allogeneic bone marrow or peripheral stem cell transplant. (time frame: 4 weeks from start of therapy). 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 23 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.