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Observational study of patients with liver cirrhosis after a worsening event

A Multicentre, Observational Study in Patients with Liver Cirrhosis Who Have Hepatic Decompensation (OPAL)

Observational Resolution Therapeutics Limited · NCT06380335

This study is tracking adults with liver cirrhosis who have had a recent health setback to see how their condition changes over time and to help improve future treatments.

Quick facts

Study typeObservational
Enrollment240 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorResolution Therapeutics Limited Research network
Drugs / interventionsprednisone
Locations18 sites (Cordoba and 17 other locations)
Trial IDNCT06380335 on ClinicalTrials.gov

What this trial studies

This multicenter observational study aims to follow the natural disease trajectory of adults with liver cirrhosis who have experienced a recent acute worsening of their condition, known as a hepatic decompensation event. Participants will be monitored for up to 96 weeks to gather real-world data on their clinical course following this event. The study will collect data during routine standard of care visits, and additional assessments will be performed as needed to ensure comprehensive data collection. The goal is to generate insights that will inform the safety and efficacy of future treatments for liver cirrhosis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of liver cirrhosis who have recently experienced a hepatic decompensation event.

Not a fit: Patients with liver cirrhosis who have not experienced a recent decompensation event may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the progression of liver cirrhosis, potentially leading to improved treatment strategies.

How similar studies have performed: While this study follows a common observational approach, the specific focus on post-decompensation trajectories in liver cirrhosis is less commonly explored, making it a novel contribution to the field.

Eligibility criteria

Show full inclusion / exclusion criteria 
Individuals eligible to participate in this study must meet the following criteria:

Inclusion Criteria:

1. Male or female age ≥18-75 years.
2. Patient is willing and able to provide informed consent to participate in the study.
3. Patient confirms willingness/ability to comply with all study procedures.
4. Has a diagnosis of liver cirrhosis determined by a physician based on at least one of the following:

   1. clinical and radiological features that correlate with a diagnosis of cirrhosis;
   2. transient elastography (TE) (FibroscanTM) \>15kPa;
   3. previous liver biopsy confirming histological features of cirrhosis.
5. 5. For eligibility at Screen Part 2 - Aetiology of liver disease of steatotic liver disease (SLD) including pure metabolic dysfunction associated steatotic liver disease (MASLD) or metabolic and alcohol related/associated liver disease (Met-ALD), or alcohol-related liver diseases (ALD).

   a. Patients with ALD or Met-ALD only if they are confirmed to not be drinking alcohol above Met-ALD limits defined in this protocol AND have phosphatidyl ethanol (PEth) test \<200 ng/ml. (N.B. No more than 34% of the total patients in this protocol will be ALD \[excludes Met-ALD\]).
6. Meets one of the following criteria:

   1. a. Hospitalised as an in-patient for a recent major hepatic decompensation event (qualifying event) including ascites, HE or variceal bleed, HRS-AKI or SBP, this being the only hospitalisation for an hepatic decompensation event within the last 6 months, and where recent is defined as within 6 weeks of hospital discharge OR
   2. Out-patient: Medically refractory ascites is defined by the repeated (≥ 2) need for LVP (i.e., therapeutic, not diagnostic) at least once per 8 weeks despite best medical attempts to control the ascites by sodium restriction and diuretic treatment, as confirmed by the Investigator, with date on of onset \[defined as the date of the second therapeutic paracentesis\] occurring within the past 6 months.
7. MELD 3.0 score of 12-20 taken within 2 weeks of qualifying event.
8. Has stabilised post-hepatic decompensation event, as defined by two MELD assessments (within 1 point of each) other taken within 2 weeks, or physician assessed as stable. with the ability to safely cell mobilise with GCSF, apherese and received RTX001 treat in the interventional Phase 1/2 study.

Exclusion Criteria:

1. Liver cirrhosis due to:

   1. any viral hepatitis , or
   2. autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis.
2. Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.
3. Any current organ failure requiring more than out-patient non-invasive supportive care, and not associated with the patient's qualifying hepatic decompensation event.
4. Known splenomegaly ≥16cm.
5. Thrombocytopenia \<50,000 mm3.
6. Sepsis (with positive microbial cultures) or as defined by the Investigator, unless stable and is at least 4 weeks after having completed a full course of intravenous antibiotics.
7. Presence or suspicion of any of the following co-morbidities:

   1. a. history of liver transplantation or other organ transplant;
   2. ACLF;
   3. known human immunodeficiency virus;
   4. pulmonary embolism;
   5. hepatocellular carcinoma, or active malignant disease within the last 5 years, (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, benign polyps etc.);
   6. co-hepatic morbidities e.g., portal vein thrombosis;
   7. hepatic hydrothorax unless it is a small hydrothorax, not clinically apparent, that is detected incidentally by radiologic evaluation that does not require clinical intervention.
   8. chronic renal impairment (on dialysis) or unresolved acute kidney injury;
   9. acute or chronic heart failure (New York Heart Association Grade III/IV);
   10. porto-pulmonary hypertension;
   11. severe chronic lung disease e.g., chronic obstructive pulmonary disease or interstitial lung disease where the forced expiratory volume (FEV1) is less than 50% and/or FEV1/forced vital capacity is less than 60%;
   12. hepatopulmonary syndrome;
   13. history or current treatment with chronic albumin treatment;
   14. significant untreated/unstable psychiatric disease;
   15. transjugular intrahepatic portosystemic shunt (TIPSS) within the previous 6 months.
8. Current or planned use of immunosuppressive medication, with the exception of low doses up to 10 mg/day prednisone or equivalent, or inhaled steroids to manage an asthma, which are permitted.
9. Any other intercurrent illness that is either life-threatening or of clinical significance such that it might limit compliance with study procedures, in the Investigator's opinion.
10. Current alcohol misuse defined as alcohol intake greater than 3 units/day for females and 4 units/day for males, or binge drinking (\>14 units/day) as determined by the Investigator or PEth alcohol test \>200 ng/ml. One alcohol unit is equivalent to14 g of alcohol: a half-pint (\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. Note: patients with history of exceeding these alcohol use limits, if meeting all other inclusion/exclusion criteria, are limited to 34% of enrolled patients.
11. Intake of non-medically supervised drugs of abuse that is judged (by the Investigator) to be a high risk to the patient's acute health or which makes the patient likely to be non-compliant with follow-up.
12. Are currently participating in an investigational interventional study. Note: concurrent participation in another non-interventional study is permitted.

Where this trial is running

Cordoba and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Liver CirrhosisLiver cirrhosisCirrhoticHepatic CirrhosisChronic Liver DiseaseLiver FibrosisDecompensated liver cirrhosisChild-Pugh Score
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.