Cytomegalovirus InfectionsPhase 2/3NCT00090766
A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
A Phase 2/3 study testing valganciclovir [Valcyte] in people with Cytomegalovirus Infections, run by Hoffmann-La Roche at 17 sites in 7 countries.
Trial summary
This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals. Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- valganciclovir [Valcyte]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 17 sitesin 7 countries
- Study dates
- May 2004to May 2005
- Phase
- Phase 2/3
- 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 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients between 3 months and 16 years of age;
- first solid organ transplant (eg, kidney, liver, heart);
- able to tolerate oral medication;
- females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug;
- patients at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV).
Who cannot join
- patients who have previously participated in this study;
- patients who are participating in another clinical trial (except with the approval of the Sponsor);
- severe, uncontrolled diarrhea (more than 5 watery stools per day);
- pregnant or lactating females.
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
United States6 sites
Study site
Ann Arbor, Michigan, 48109-0297
Study site
Indianapolis, Indiana, 46202-5124
Study site
Los Angeles, California, 90095-1752
Study site
New York, New York, 10029
Study site
Salt Lake City, Utah, 84132-2806
Study site
St Louis, Missouri, 63110
Spain3 sites
Study site
Madrid, 28041
Study site
Madrid, 28046
Study site
Valencia, 46009
Canada2 sites
Study site
Edmonton, Alberta, T6G 2R7
Study site
Winnipeg, Manitoba, R3A 1S1
About this study
Official title: Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients
This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.
- Conditions
- Cytomegalovirus Infections
- Being tested
- valganciclovir [Valcyte]
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valganciclovir [Valcyte]Drug
po daily (dose based on body surface area and CrCL)
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir Age Group <= 2 Years | Experimental | Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * body surface area (BSA) * creatinine clearance (CrCLS). Receives: Drug: valganciclovir [Valcyte] |
| Valganciclovir Age Group >2 to <12 Years | Experimental | Eligible participants aged >2 to <12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS. Receives: Drug: valganciclovir [Valcyte] |
| Valganciclovir Age Group >= 12 Years | Experimental | Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS. Receives: Drug: valganciclovir [Valcyte] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir
Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Measured: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
Number of Participants With Adverse Events Leading to Dose Interruption or Modification
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.
Measured: Up to Week 26
Number of Participants With Opportunistic Infections
Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.
Measured: Up to Week 26
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Measured: Up to Week 26
Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.
Measured: Up to Week 26
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Measured: Up to Week 26
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Measured: Up to Week 26
Secondary outcomes (6)
Number of Participants With Cytomegalovirus Disease Over Time
Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.
Measured: Up to Week 26
Number of Participants With Treatment Failures
Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.
Measured: Up to Week 26
Number of Participants Who Experienced Graft Loss
Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.
Measured: Up to Week 26
Mean Maximum Plasma Concentration of Valganciclovir Over Time
Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Measured: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14
Mean Elimination Half-Life of Valganciclovir Over Time
The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.
Measured: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
Number of Participants Who Experienced Episodes of Rejection Over Time
Participants with biopsy proven active rejection are reported.
Measured: Up to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2004 (estimated)
- Study startMay 2004
- Primary completionMay 2005
- Study completionMay 2005
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.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090766
- Sponsor's protocol ID
- WV16726
- Status last verified
- Mar 2016
- First submitted
- 3 Sep 2004
- Last updated
- 31 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT00090766
- Acronym / sponsor ID
- WV16726
- Conditions
- Cytomegalovirus Infections
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 6 Sep 2004 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir Age Group <= 2 Years | Experimental | Drug: valganciclovir [Valcyte]Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * body surface area (BSA) * creatinine clearance (CrCLS). |
| Valganciclovir Age Group >2 to <12 Years | Experimental | Drug: valganciclovir [Valcyte]Eligible participants aged >2 to <12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS. |
| Valganciclovir Age Group >= 12 Years | Experimental | Drug: valganciclovir [Valcyte]Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS. |
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- patients between 3 months and 16 years of age;
- first solid organ transplant (eg, kidney, liver, heart);
- able to tolerate oral medication;
- females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug;
- patients at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV).
Key exclusion criteria (4 listed)
- patients who have previously participated in this study;
- patients who are participating in another clinical trial (except with the approval of the Sponsor);
- severe, uncontrolled diarrhea (more than 5 watery stools per day);
- pregnant or lactating females.
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 [Valcyte]po daily (dose based on body surface area and CrCL) | Drug | Valganciclovir Age Group <= 2 Years, Valganciclovir Age Group >2 to <12 Years, Valganciclovir Age Group >= 12 Years |
Primary outcome
Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir
Time frame: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Number of Participants With Adverse Events Leading to Dose Interruption or Modification
Time frame: Up to Week 26
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.
Number of Participants With Opportunistic Infections
Time frame: Up to Week 26
Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Time frame: Up to Week 26
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug
Time frame: Up to Week 26
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
Time frame: Up to Week 26
The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
Time frame: Up to Week 26
The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
6 secondary outcomes
Number of Participants With Cytomegalovirus Disease Over Time
Time frame: Up to Week 26
Number of Participants With Treatment Failures
Time frame: Up to Week 26
Number of Participants Who Experienced Graft Loss
Time frame: Up to Week 26
Mean Maximum Plasma Concentration of Valganciclovir Over Time
Time frame: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14
Mean Elimination Half-Life of Valganciclovir Over Time
Time frame: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
Number of Participants Who Experienced Episodes of Rejection Over Time
Time frame: Up to Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing valganciclovir [Valcyte] in people with Cytomegalovirus Infections, run by Hoffmann-La Roche at 17 sites in 7 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 5 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Spain, Canada, France, Mexico and 2 more countries. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 31 Oct 2016). 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?
Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir (time frame: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14). The study lists 7 primary outcomes in all. 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 31 Oct 2016.