Cytomegalovirus DiseasePhase 4NCT01509404
Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection
A Phase 4 study testing Valganciclovir and CMV hyperimmune globulin in people with Cytomegalovirus Disease, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Disease
- What is being tested?
- Valganciclovir and CMV hyperimmune globulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female patients ≥ 18 years of age.
- Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.
- The patient has given written informed consent to participate in the study.
Who cannot join
- Solid organ transplant recipient is CMV seropositive at the time of transplant.
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
- Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
- Patients with thrombocytopenia (<25,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
- Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
- Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.
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- Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
- Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
- Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
- Inability to cooperate or communicate with the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.
- Conditions
- Cytomegalovirus Disease
- Being tested
- Valganciclovir, CMV hyperimmune globulin
- Keywords
- CMV, cytomegalovirus, transplant
- 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
Also called Valcyte
Valcyte per package insert guidelines for 200 days post transplant
CMV hyperimmune globulinBiological
Also called Cytogam
100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant
ValganciclovirDrug
Also called Valcyte
valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant
| Study group | Role | What they receive |
|---|---|---|
| Valcyte | Active comparator | valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant Receives: Drug: Valganciclovir |
| Valcyte then Cytogam | Active comparator | valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection Receives: Biological: CMV hyperimmune globulin; Drug: Valganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Late CMV Disease
Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant
Measured: after 200 days post-transplant until 2 years post-transplant
Secondary outcomes (7)
Number of Patients With Early CMV Infection
Measured: 100 days
Number of Patients With Cell Mediated Immunity
Positive CMV quantiferon at last follow-up
Measured: 2 years
Renal Function
Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant
Measured: 6, 12, and 24 months after transplant
Number of Participants With Acute Cellular and/or Antibody Mediated Rejection
Measured: 2 years
Number of Participants With Opportunistic Infections
Measured: 2 years
Number of Participants With Asymptomatic CMV Viremia
Measured: 2 years
Number of Participants With CMV Seroconversions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509404
- Sponsor's protocol ID
- Pro00009601
- Status last verified
- Sep 2018
- First submitted
- 10 Jan 2012
- Last updated
- 4 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
PubMed 39807668
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection
- ClinicalTrials.gov ID
- NCT01509404
- Acronym / sponsor ID
- Pro00009601
- Conditions
- Cytomegalovirus Disease
- Keywords
- CMV, cytomegalovirus, transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Nov 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Posted 4 Oct 2018
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 the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valcyte | Active comparator | Drug: Valganciclovirvalganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant |
| Valcyte then Cytogam | Active comparator | Biological: CMV hyperimmune globulin, Drug: Valganciclovirvalganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients ≥ 18 years of age.
- Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.
- The patient has given written informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Solid organ transplant recipient is CMV seropositive at the time of transplant.
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
- Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
- Patients with thrombocytopenia (<25,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
- Patient is taking or has been taking an investigational drug in the 30 days prior to 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 |
|---|---|---|
| ValganciclovirAlso: ValcyteValcyte per package insert guidelines for 200 days post transplant | Drug | Valcyte |
| CMV hyperimmune globulinAlso: Cytogam100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant | Biological | Valcyte then Cytogam |
| ValganciclovirAlso: Valcytevalganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant | Drug | Valcyte then Cytogam |
Primary outcome
Number of Patients With Late CMV Disease
Time frame: after 200 days post-transplant until 2 years post-transplant
Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant
7 secondary outcomes
Number of Patients With Early CMV Infection
Time frame: 100 days
Number of Patients With Cell Mediated Immunity
Time frame: 2 years
Renal Function
Time frame: 6, 12, and 24 months after transplant
Number of Participants With Acute Cellular and/or Antibody Mediated Rejection
Time frame: 2 years
Number of Participants With Opportunistic Infections
Time frame: 2 years
Number of Participants With Asymptomatic CMV Viremia
Time frame: 2 years
Number of Participants With CMV Seroconversions
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39807668Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valganciclovir and CMV hyperimmune globulin in people with Cytomegalovirus Disease, run by Medical University of South Carolina 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 4 inclusion and 10 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 4 Oct 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Late CMV Disease (time frame: after 200 days post-transplant until 2 years post-transplant). 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 NCT01509404, 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 4 Oct 2018.