ANSWER trial | MACHT trial | |
Type | Randomised Open label | Randomised Placebo controlled |
Interventional treatment | HA 40 g twice a week for 2 weeks, then 40 g every week. | HA 40 g every 15 days plus midodrine. |
Total number of patients (number of patients in each group) | 431 (218 HA/213 SMT) | 173 (87 HA+midodrine/86 SMT) |
Number (%) of patients in waiting list for LT at enrolment | 34 (8) | 173 (100) |
MELD at enrolment (HA/SMT) | 12/13 | 17/18 |
Duration of interventional treatment | 17.6 (8.0–18.0) months* | 63 days† |
Number (%) of patients under-going LT during the follow-up | 37 (9) | 106 (61) |
Effect of interventional treatment on serum albumin concentration | Increase in serum albumin concentration (0.6–0.8 g/dL) in the first month. | No significant change. |
Outcomes according to the interventional treatment | Reduction of mortality and complications. | No effect on mortality or complications. |
*Median calculated by reverse Kaplan‐Meier method.
†Median.
HA, human albumin; LT, liver transplantation; MELD, model for end-stage liver disease; SMT, standard medical treatment.