Phase 3
Completed N=63
A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Cytomegalovirus Infections
Source: ClinicalTrials.gov NCT00090766 ↗
Enrolled (actual)
63
Serious AEs
55.6%
Results posted
Oct 2016
Primary outcomePrimary: Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir — 65.2; 55; 50; 69.4 mcg*hr/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir |
65.2; 55; 50; 69.4; 58.4; 35.6 | — |
| PRIMARY Number of Participants With Adverse Events Leading to Dose Interruption or Modification |
4; 2; 3 | — |
| PRIMARY Number of Participants With Opportunistic Infections |
2; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Any Adverse Events and Any Serious Adverse Events |
17; 18; 24; 13; 11; 11 | — |
| PRIMARY Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug |
1; 2; 0 | — |
| PRIMARY Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry |
6; 3; 3; 7; 4; 4 | — |
| PRIMARY Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry |
0; 1; 3; 4; 0; 2 | — |
| SECONDARY Number of Participants With Cytomegalovirus Disease Over Time |
0; 2; 2 | — |
| SECONDARY Number of Participants With Treatment Failures |
2; 2; 0 | — |
| SECONDARY Number of Participants Who Experienced Graft Loss |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Mean Maximum Plasma Concentration of Valganciclovir Over Time |
10; 8.74; 7.85; 11.7; 9.35; 5.55 | — |
| SECONDARY Mean Elimination Half-Life of Valganciclovir Over Time |
3.1; 4.47; 5.69; 2.72; 3.61; 4.5 | — |
| SECONDARY Number of Participants Who Experienced Episodes of Rejection Over Time |
5; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00090766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.