Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RTX001 · 1 trial · 8 indications
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
| Arm | Type | Description |
|---|---|---|
| RTX001 | EXPERIMENTAL | Following the manufacture of RTX001, participants will be assigned into one of two groups based on the compensation status of their cirrhosis at this time as follows: * Stabilised Group: Participants who remain clinically stable, as assessed by the Investigator, since their qualifying decompensation event. * Subsequent Decompensation Group: Participants who have had a further decompensation event following their leukapheresis and/or the RTX001 manufacturing process. Treatment will be identical for both groups, and each participant will receive a maximum of four doses of RTX001 by intravenous infusion Patients in the Subsequent Decompensation Group need to have stabilised before receiving treatment. |
| Name | Type | Description |
|---|---|---|
| RTX001 | DRUG | RTX001 is an autologous engineered regenerative macrophage cell therapy |
Individuals eligible to participate in this study must meet the following criteria: Inclusion Criteria: 1. Male or female age ≥18-75 years. 2. Patient confirms willingness/ability to comply with all study procedures. 3. Diagnosis of liver cirrhosis based on at least one of: 1. Clinical and rad...