Table of Contents
- Overview of the trials
- Ovarian cancer studies
- Liver disease and cirrhosis studies
- Septic shock and kidney injury study
- Other trials using Human Serum Albumin
- Main endpoints and what they mean
- Who may take part
Overview of the trials
The trial data show several studies of Human Serum Albumin in very different clinical settings, including cancer, liver disease, critical illness, and eye injury.[1][2][3][4][5][6]
Most trials are Phase 3, with some Phase 2 studies and one Phase 1/2 trial.[1][2][3][4][5][6][7]
These studies are interventional, which means researchers give a treatment or procedure and then measure the results.[1][2][3][4][5][6][7]
Ovarian cancer studies
Two trials study sentinel lymph node detection in early-stage ovarian cancer, including epithelial ovarian cancer in early stages.[1][2]
In these studies, Human Serum Albumin appears as part of the tracer or detection approach used during surgery or mapping of lymph nodes.[1][2]
The main goal is to see how well the sentinel lymph node technique finds cancer spread, using measures such as the negative predictive value and the global detection rate.[1][2]
One trial compares the sentinel node technique with pelvic and aortic lymphadenectomy, which is surgery to remove lymph nodes and use that as the gold standard for checking spread.[1]
The ovarian cancer studies are in Phase 3 and Phase 2, with planned enrollment of 200 and 62 patients.[1][2]
Liver disease and cirrhosis studies
Several trials focus on cirrhosis, which is long-term scarring of the liver, and its complications.[3][4][5][6]
One Phase 3 study in critically ill patients with septic shock and high risk of acute kidney injury tests whether Human Serum Albumin can reduce severe kidney injury during the first 7 days after shock begins.[3]
Another Phase 2 trial in decompensated cirrhosis studies a combination of Human Serum Albumin and enoxaparin, with a main focus on safety and tolerability, including treatment-emergent adverse events, pulmonary edema, severe thrombocytopenia, and major bleeding.[4]
A Phase 3 trial in decompensated cirrhosis and AKI 1B or greater compares intravenous Human Serum Albumin with saline solution to see whether kidney function improves and whether acute kidney injury resolves.[5]
Two related Phase 3 cirrhosis trials look at a personalized approach to Human Serum Albumin therapy and measure liver-related outcomes such as variceal bleeding, ascites, spontaneous bacterial peritonitis, infection needing hospitalization, acute kidney injury, and overt hepatic encephalopathy.[6][7]
One of these cirrhosis studies was withdrawn, while the other remains authorised.[6][7]
Another completed Phase 3 trial in cirrhosis with ACLF-1b, ACLF-2, or ACLF-3a studied whether standard medical treatment plus PE-A 5% improves 90-day overall survival compared with standard treatment alone.[8]
Septic shock and kidney injury study
The septic shock trial is for critically ill patients with a high risk of acute kidney injury (AKI), which means sudden kidney damage.[3]
The study measures the incidence of AKI reaching KDIGO stage 2-3 during the first 7 days after septic shock starts.[3]
This is a Phase 3 randomized controlled trial, meaning patients are assigned to treatment groups by chance.[3]
Other trials using Human Serum Albumin
One Phase 1/2 solid tumor trial includes Human Serum Albumin among several infusion drugs used in the study program.[9]
This trial is mainly designed to test safety, dose-limiting toxicities, serious treatment-emergent adverse events, and anti-tumor activity in patients with recurrent and/or refractory solid tumors.[9]
Another Phase 2 trial in severe eye chemical burns uses ALBUTEIN 50 g/L as part of a subconjunctival injection protocol with mesenchymal stromal cells, and the main endpoint is absence of corneal perforation.[10]
This eye study is focused on preserving the eyeball 6 months after the first injection.[10]
Main endpoints and what they mean
A primary outcome is the main result the researchers want to measure.[1]
In these trials, primary outcomes include negative predictive value, detection rate, incidence of severe AKI, safety events, kidney recovery, overall survival, and absence of corneal perforation.[1][2][3][4][5][8][9][10]
Some studies use terms like overall survival, which means how long people live after treatment starts, and objective response rate, which means how many patients have their tumors shrink or disappear.[8][9]
Other studies look at liver-related events such as ascites, variceal bleeding, spontaneous bacterial peritonitis, and hepatic encephalopathy, which is confusion caused by severe liver disease.[6][7]
Who may take part
The studies include people with early-stage ovarian cancer, cirrhosis, decompensated cirrhosis, septic shock, acute kidney injury, recurrent and/or refractory solid tumors, and severe eye chemical burns.[1][2][3][4][5][6][7][8][9][10]
Some trials are for hospitalized or critically ill patients, while others focus on surgical or cancer staging settings.[1][3][5][8]
Each study has its own rules for who can join, based on the disease stage and the clinical situation described in the trial record.[1][3][5][8]
