An Open-label Phase 1/2 Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of RTX001 Autologous Macrophages in Participants with Liver Cirrhosis who have Hepatic Decompensation (EMERALD)

Conditions

Liver Cirrhosis

Brief summary

1. Incidence and severity of TEAEs and SAEs, 2. Changes from baseline in safety assessments, 3. Incidence and severity of infusion reactions

Detailed description

Time-to, incidence and severity of: 1. Development of a second portal hypertension-driven decompensating event (ascites, variceal haemorrhage or hepatic encephalopathy)., 2. Development of recurrent variceal bleeding, recurrent ascites (requirement of ≥3 large-volume paracenteses within 1 year), recurrent encephalopathy, development of SBP and/or HRS-AKI, 3. In participants presenting with bleeding alone, development of ascites, or encephalopathy, after recovery from bleeding (but not if these events occur around the time of bleeding), 4. All hepatic decompensation events including SBP and/or HRS-AKI, new listing for liver transplantation or liver transplantation, 5. Mortality (hepatic related and all-cause), transplant-free survival., 6. ΔMELD, ΔΔMELD and MELD stabilisation

Related papers

No related papers found yet.

Interventions

DRUGRTX001

DRUGNeupogen 30 MU (0

DRUG6 mg/ml) solución inyectable en jeringa precargada filgrastim

DRUGNeupogen 48 MU (0

DRUG96 mg/ml) solución inyectable en jeringa precargada filgrastim

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence and severity of TEAEs and SAEs, 2. Changes from baseline in safety assessments, 3. Incidence and severity of infusion reactions	—

Secondary

Measure	Time frame
Time-to, incidence and severity of: 1. Development of a second portal hypertension-driven decompensating event (ascites, variceal haemorrhage or hepatic encephalopathy)., 2. Development of recurrent variceal bleeding, recurrent ascites (requirement of ≥3 large-volume paracenteses within 1 year), recurrent encephalopathy, development of SBP and/or HRS-AKI, 3. In participants presenting with bleeding alone, development of ascites, or encephalopathy, after recovery from bleeding (but not if these events occur around the time of bleeding), 4. All hepatic decompensation events including SBP and/or HRS-AKI, new listing for liver transplantation or liver transplantation, 5. Mortality (hepatic related and all-cause), transplant-free survival., 6. ΔMELD, ΔΔMELD and MELD stabilisation	—

Measure

Time frame

Time-to, incidence and severity of: 1. Development of a second portal hypertension-driven decompensating event (ascites, variceal haemorrhage or hepatic encephalopathy)., 2. Development of recurrent variceal bleeding, recurrent ascites (requirement of ≥3 large-volume paracenteses within 1 year), recurrent encephalopathy, development of SBP and/or HRS-AKI, 3. In participants presenting with bleeding alone, development of ascites, or encephalopathy, after recovery from bleeding (but not if these events occur around the time of bleeding), 4. All hepatic decompensation events including SBP and/or HRS-AKI, new listing for liver transplantation or liver transplantation, 5. Mortality (hepatic related and all-cause), transplant-free survival., 6. ΔMELD, ΔΔMELD and MELD stabilisation

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Countries

Spain

Outcome results

None listed