Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Valganciclovir · 6 trials · 4 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 an investigational small molecule being studied for the prevention and treatment of Cytomegalovirus (CMV) infections, including in heart transplant recipients and for Cytomegalovirus Retinitis. It is developed by Roche Holding AG (RHHBY) and is currently in Phase 3 clinical development.
Valganciclovir is an antiviral drug that works by inhibiting viral DNA replication. It is a prodrug of ganciclovir, which is converted to the active form inside infected cells. This mechanism targets the CMV virus, reducing its ability to multiply and spread.
Valganciclovir is developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker RHHBY on the OTC market. The drug is being investigated for use in CMV infections and related conditions.
Valganciclovir is in Phase 3 clinical development. It has completed four clinical trials, including a Phase 3 study comparing oral valganciclovir to placebo for CMV prevention after lung transplantation. The drug is investigational and not yet approved.
Valganciclovir has completed four trials, including NCT00090766 (pediatric solid organ transplant), NCT00227370 (Phase 3 lung transplant CMV prevention), NCT00377741 (bioavailability in lung transplant), and NCT01165580 (pediatric heart transplant pharmacokinetics). All trials are completed with no active studies.
Valganciclovir is the generic name for the drug marketed as Valcyte. Clinical trials listed under NCT numbers refer to Valcyte (valganciclovir) in their titles, confirming they are the same compound. Roche develops both the branded and generic forms.