Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MCMV3068A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| MCMV5322A/MCMV3068A | EXPERIMENTAL | Participants will receive a total of four doses of study drug administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57. MCMV5322A/MCMV3068A will be tested in this study at 10 milligrams per kilogram (mg/kg) of each component antibody. Thus, at each dose, 10 mg/kg of MCMV5322A and 10 mg/kg of MCMV3068A will be tested (20 mg/kg total). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a total of four doses of placebo matched with MCMV5322A/MCMV3068A administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57. |
| Name | Type | Description |
|---|---|---|
| MCMV3068A | DRUG | Four doses of MCMV3068A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57. |
| MCMV5322A | DRUG | Four doses of MCMV5322A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57. |
| Placebo | DRUG | Four doses of placebo matched to MCMV5322A/MCMV3068A administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57. |
Inclusion Criteria: * Participant is scheduled to receive a primary or secondary renal allograft from a donor * Participant is seronegative for CMV and is receiving an allograft from a CMV-seropositive donor * Female participants of child-bearing age must have a negative pregnancy test result on Da...
MCMV3068A is an investigational small molecule being studied for the prevention of cytomegalovirus disease in high-risk kidney allograft recipients. It is being developed by Roche Holding AG (ticker: RHHBY) and is currently in Phase 2 clinical development for cytomegalovirus infections.
MCMV3068A is a small molecule designed to target cytomegalovirus. It is being investigated for its ability to prevent cytomegalovirus disease in high-risk kidney transplant recipients. The specific molecular target has not been disclosed.
MCMV3068A is being developed by Roche Holding AG, a multinational healthcare company. The company's stock is traded under the ticker RHHBY. The drug is currently in Phase 2 clinical development for the prevention of cytomegalovirus disease.
MCMV3068A is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to evaluate its safety and efficacy in preventing cytomegalovirus disease in high-risk kidney transplant recipients.
MCMV3068A has been studied in one clinical trial, NCT01753167, titled 'A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients.' This Phase 2, double-blind, placebo-controlled trial enrolled 122 participants and has been completed.
MCMV3068A is studied in combination with MCMV5322A in the clinical trial NCT01753167. The trial evaluates both agents for the prevention of cytomegalovirus disease in high-risk kidney allograft recipients. MCMV3068A is a separate investigational drug being developed by Roche.