Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as valganciclovir [Valcyte], Valganciclovir (Pre-emptive CMV Therapy), Valcyte
valganciclovir · 7 trials · 5 indications
Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.
The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.
CMV clinical syndrome, with either positive serum PCR or positive culture for CMV from bronchoalveolar lavage and at least 2 of the following: fever, leukopenia, thrombocytopenia, elevated liver function test results malaise, reduction in pulmonary function (FEV1) greater than 20percent of baseline, or radiographic infiltrate consistent with CMV (all in the absence of other causes)
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.
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.
Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.
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.
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.
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.
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.
The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC \[0-tau\]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.
The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.
| Arm | Type | Description |
|---|---|---|
| Valganciclovir up to 100 days | EXPERIMENTAL | Valganciclovir for up to 100 days post kidney transplant |
| Valganciclovir up to 200 days | ACTIVE_COMPARATOR | Valganciclovir for up to 200 days post kidney transplant |
| 1 | ACTIVE_COMPARATOR | Valganciclovir 900 mg QD for 9 months post lung transplant. |
| 2 | PLACEBO_COMPARATOR | placebo for 9 months post lung transplant |
| 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). |
| 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. |
| 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. |
| Single Arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Valganciclovir | DRUG | 900 mg orally daily for up to 100 days |
| Placebo | OTHER | - |
| Ganciclovir | DRUG | - |
| valganciclovir [Valcyte] | DRUG | po daily (dose based on body surface area and CrCL) |
Inclusion Criteria: * ≥ 16 years of age * CMV seronegative recipient of primary or secondary renal allograft from a living or cadaveric seropositive donor * Adequate hematological and renal function * Patients and partners must agree to maintain effective birth control for 90 days following cessati...
Valganciclovir is used to treat and prevent cytomegalovirus (CMV) infections. Its studied uses include prevention of CMV disease in kidney and lung transplant recipients, treatment of CMV retinitis, and management of CMV infections in heart transplant patients and in people with human herpesvirus 8.
Valganciclovir is developed and marketed by Roche Holding AG, which trades under the ticker RHHBY. Roche's brand name for the drug is Valcyte.
Valganciclovir has been studied in Phase 3 clinical trials. The Phase 3 program includes the IMPACT study in kidney transplant recipients and a placebo-controlled trial in lung transplant recipients. Phase 1 pharmacokinetic and bioavailability studies have also been completed.
Valganciclovir has been evaluated in four registered trials. These include NCT00294515, the Phase 3 IMPACT study for CMV prevention in kidney transplant recipients, NCT00227370, a Phase 3 trial in lung transplant recipients, and two Phase 1 studies, NCT01165580 in pediatric heart transplant recipients and NCT00377741 in lung transplant recipients.
Yes, Valcyte is the brand name for valganciclovir. The two names refer to the same drug. Valganciclovir is also studied under the description Valganciclovir (Pre-emptive CMV Therapy), which refers to its use for pre-emptive treatment of cytomegalovirus.