Cytomegalovirus Infections, Heart TransplantationPhase 1NCT01165580
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
A Phase 1 study testing valganciclovir [Valcyte] in people with Cytomegalovirus Infections, Heart Transplantation, run by Hoffmann-La Roche at 19 sites in 3 countries.
Trial summary
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age. Read more about this study
- Who is it for?
- Ages Up to 124 days
- Conditions the study is for
- Cytomegalovirus Infections, Heart Transplantation
- 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
- 17 participants
- Where
- 19 sitesin 3 countries
- Study dates
- May 2011to Sep 2013
- Phase
- Phase 1
- 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 Up to 124 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females, 0 to < 4 months (< 125 days) of age at the time of the last PK assessment in this study
- Parent or guardian of the patient is willing and able to give written informed consent
- Patient has received a first heart transplant
- Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
- Adequate hematological and renal function
- Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)
Who cannot join
- Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
- Severe, uncontrolled, clinically abnormal diarrhea
- Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
- Patient requires use of any protocol prohibited concomitant medications
- Patient has previously participated in this clinical trial
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United States16 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Atlanta, Georgia, 30322
Study site
Aurora, Colorado, 80045
Study site
Charleston, South Carolina, 29425
Study site
Cincinnati, Ohio, 45229
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75390
Study site
Detroit, Michigan, 48201
Study site
Durham, North Carolina, 22710
Study site
Loma Linda, California, 92354
Study site
Milwaukee, Wisconsin, 53226
Study site
Nashville, Tennessee, 37232-9119
Study site
Palo Alto, California, 94304
Study site
Seattle, Washington, 98105
Study site
St Louis, Missouri, 63110
Study site
The Bronx, New York, 10467
About this study
Official title: Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.
- 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
oral dose, Days 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: valganciclovir [Valcyte] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration versus time curve of ganciclovir
Measured: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Apparent volume of distribution of ganciclovir
Measured: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Terminal half-life of ganciclovir
Measured: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Peak concentration of ganciclovir
Measured: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Secondary outcomes (1)
Safety (Incidence of adverse events)
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startMay 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus Infections, Heart TransplantationStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT01165580
- Sponsor's protocol ID
- NP22523
- Other IDs
- 2010-021172-28
- Status last verified
- Nov 2016
- First submitted
- 16 Jul 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age
- ClinicalTrials.gov ID
- NCT01165580
- Acronym / sponsor ID
- NP22523
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Jul 2010 (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.
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: valganciclovir [Valcyte] |
Who may qualify
- Ages
- Up to 124 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Males and females, 0 to < 4 months (< 125 days) of age at the time of the last PK assessment in this study
- Parent or guardian of the patient is willing and able to give written informed consent
- Patient has received a first heart transplant
- Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
- Adequate hematological and renal function
Key exclusion criteria (5 listed)
- Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
- Severe, uncontrolled, clinically abnormal diarrhea
- Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
- Patient requires use of any protocol prohibited concomitant medications
- Patient has previously participated in this clinical trial
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]oral dose, Days 1 and 2 | Drug | Single Arm |
Primary outcome
Area under plasma concentration versus time curve of ganciclovir
Time frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Apparent volume of distribution of ganciclovir
Time frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Terminal half-life of ganciclovir
Time frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Peak concentration of ganciclovir
Time frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
1 secondary outcome
Safety (Incidence of adverse events)
Time frame: 9 days
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 2 Nov 2016.
Related trials for Cytomegalovirus Infections, Heart Transplantation
Active, not recruitingPhase 2
Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients
Cytomegalovirus Infections, Transplant-Related Disorder
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
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing valganciclovir [Valcyte] in people with Cytomegalovirus Infections, Heart Transplantation, run by Hoffmann-La Roche at 19 sites in 3 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 6 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Spain, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under plasma concentration versus time curve of ganciclovir (time frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose). The study lists 4 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 2 Nov 2016.