Liver CirrhosisOPALNCT06380335
Study in Patients With Decompensated Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Resolution Therapeutics Limited at 12 sites in 2 countries.
Trial summary
OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 24 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 10 Oct 2023to 3 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients with liver cirrhosis who have been hospitalized for hepatic decompensation. 2. Out-patients with refractory ascites that does not require in-patient admission.
Who may be able to join
- Male or female age ≥18-75 years.
- Patient is willing and able to provide informed consent to participate in the study.
- Patient confirms willingness/ability to comply with all study procedures.
- Has a diagnosis of liver cirrhosis determined by a physician based on at least one of the following:
- clinical and radiological features that correlate with a diagnosis of cirrhosis;
- transient elastography (TE) (FibroscanTM) >15kPa;
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- previous liver biopsy confirming histological features of cirrhosis.
- 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).
- 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]).
- Meets one of the following criteria:
- 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
- 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.
- MELD 3.0 score of 12-20 taken within 2 weeks of qualifying event.
- 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.
Who cannot join
- Liver cirrhosis due to:
- any viral hepatitis , or
- autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis.
- Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.
- Any current organ failure requiring more than out-patient non-invasive supportive care, and not associated with the patient's qualifying hepatic decompensation event.
- Known splenomegaly ≥16cm.
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- Thrombocytopenia <50,000 mm3.
- 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.
- Presence or suspicion of any of the following co-morbidities:
- a. history of liver transplantation or other organ transplant;
- ACLF;
- known human immunodeficiency virus;
- pulmonary embolism;
- 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.);
- co-hepatic morbidities e.g., portal vein thrombosis;
- hepatic hydrothorax unless it is a small hydrothorax, not clinically apparent, that is detected incidentally by radiologic evaluation that does not require clinical intervention.
- chronic renal impairment (on dialysis) or unresolved acute kidney injury;
- acute or chronic heart failure (New York Heart Association Grade III/IV);
- porto-pulmonary hypertension;
- 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%;
- hepatopulmonary syndrome;
- history or current treatment with chronic albumin treatment;
- significant untreated/unstable psychiatric disease;
- transjugular intrahepatic portosystemic shunt (TIPSS) within the previous 6 months.
- 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.
- 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.
- 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.
- 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.
- Are currently participating in an investigational interventional study. Note: concurrent participation in another non-interventional study is permitted.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United Kingdom10 sites
Bristol Royal Infirmary
Bristol, BS2 8HW
Royal Infirmary Edinburgh
Edinburgh, EH16 4SA
Leeds Teaching Hospital NHS Trust
Leeds, LS9 7TF
Royal Liverpool Hospital
Liverpool, L7 8XP
King's College Hospital
London, SE5 9RS
St George's Hospital
London, SW17 0QT
St Mary's Hospital
London, W2 1NY
Nottingham University Hospital
Nottingham, NG5 1PB
Southampton General Hospital
Southampton, SO16 6YD
Sunderland Royal Hospital
Sunderland, SR4 7TP
Spain2 sites
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital General Universitario Gregorio Marañón
Madrid, 28007
About this study
Official title: A Multicentre, Observational Study in Patients With Liver Cirrhosis Who Have Hepatic Decompensation (OPAL)
OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient.
Read the detailed description
This multicenter, observational natural history study is designed to follow the disease trajectory of adults with cirrhosis of the liver who have a qualifying hepatic decompensation event.
The primary objective of the study is to obtain real world data to understand the clinical course of cirrhotic patients following a decompensation event in order to generate data to provide context for the safety and efficacy evaluation of future interventional treatments. Observed data will be collected from the visits and assessments conducted as part of the routine standard of care (SOC) follow-up of these patients. In addition, given the variability in SOC and timing of follow-up visits across institutions, if study required assessments do not coincide with a routine SOC visit at the institution, blood draws and other study-specific assessments will be collected at defined time points for the study analysis.
All participants who meet the eligibility criteria and stabilize following a hepatic decompensation event will have their clinical course followed for up to 96 weeks, and then be invited to participate in the study long term follow observational phase for a further 3 years.
- Conditions
- Liver Cirrhosis
- Keywords
- Liver cirrhosis, Cirrhotic, Hepatic Cirrhosis, Chronic Liver Disease, Liver Fibrosis, Decompensated liver cirrhosis, Child-Pugh Score, MELD score, Liver function tests, Hepatic encephalopathy, End Stage Liver Disease (ESLD), Retractable ascites, Variceal Bleeding
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with liver cirrhosis who have been hospitalised following a recent hepatic decompensation which is at least 6 months after any hospitalisation for a prior decompensation event. | |
| Group 2 | Out-patients with medically refractory ascites that recurs (i.e., second LVP) within a 6-month period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Demographics
Measured: Baseline and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Aetiology of liver disease
Measured: Baseline and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Disease co-morbidities
Measured: Baseline and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Alcohol use
Measured: Baseline, and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Changes in Model for End-Stage Liver Disease (MELD) score
Measured: Baseline, and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Safety laboratory (biochemistry and haematology) parameters
Measured: Baseline, and up to 96 weeks
Secondary outcomes (11)
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Death or liver transplantation
Measured: Screening up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Major hepatic decompensation events
Measured: Screening up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Hospitalisations or intensive care unit (ICU) admissions
Measured: Screening up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Changes in Model for End-Stage Liver Disease (MELD) score
Measured: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Demographics
Measured: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Safety laboratory (biochemistry and haematology) parameters
Measured: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Disease co morbidities
Measured: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Alcohol use
Measured: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Changes in MELD score
Measured: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Death or liver transplantation
Measured: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Further hepatic decompensation events
Measured: Screening up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start10 Oct 2023
- Primary completion3 Apr 2030 (estimated)
- Study completion3 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resolution Therapeutics Limited
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380335
- Sponsor's protocol ID
- RTX001-01S
- Acronym
- OPAL
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Observational Study in Patients With Liver Cirrhosis Who Have Hepatic Decompensation (OPAL)
- ClinicalTrials.gov ID
- NCT06380335
- Acronym / sponsor ID
- OPAL / RTX001-01S
- Conditions
- Liver Cirrhosis
- Keywords
- Liver cirrhosis, Cirrhotic, Hepatic Cirrhosis, Chronic Liver Disease, Liver Fibrosis, Decompensated liver cirrhosis, Child-Pugh Score, MELD score
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Resolution Therapeutics LimitedResearch network
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 3 Apr 2030 (estimated)
- Study completion
- 3 Apr 2030 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient.
Detailed description
This multicenter, observational natural history study is designed to follow the disease trajectory of adults with cirrhosis of the liver who have a qualifying hepatic decompensation event.
The primary objective of the study is to obtain real world data to understand the clinical course of cirrhotic patients following a decompensation event in order to generate data to provide context for the safety and efficacy evaluation of future interventional treatments. Observed data will be collected from the visits and assessments conducted as part of the routine standard of care (SOC) follow-up of these patients. In addition, given the variability in SOC and timing of follow-up visits across institutions, if study required assessments do not coincide with a routine SOC visit at the institution, blood draws and other study-specific assessments will be collected at defined time points for the study analysis.
All participants who meet the eligibility criteria and stabilize following a hepatic decompensation event will have their clinical course followed for up to 96 weeks, and then be invited to participate in the study long term follow observational phase for a further 3 years.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with liver cirrhosis who have been hospitalised following a recent hepatic decompensation which is at least 6 months after any hospitalisation for a prior decompensation event. |
| Group 2 | – | –Out-patients with medically refractory ascites that recurs (i.e., second LVP) within a 6-month period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with liver cirrhosis who have been hospitalized for hepatic decompensation. 2. Out-patients with refractory ascites that does not require in-patient admission.
Key inclusion criteria (14 listed)
- Male or female age ≥18-75 years.
- Patient is willing and able to provide informed consent to participate in the study.
- Patient confirms willingness/ability to comply with all study procedures.
- Has a diagnosis of liver cirrhosis determined by a physician based on at least one of the following:
- 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).
Key exclusion criteria (29 listed)
- Liver cirrhosis due to:
- Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.
- Any current organ failure requiring more than out-patient non-invasive supportive care, and not associated with the patient's qualifying hepatic decompensation event.
- Known splenomegaly ≥16cm.
- Thrombocytopenia <50,000 mm3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Time frame: Baseline and up to 96 weeks
Demographics
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Time frame: Baseline and up to 96 weeks
Aetiology of liver disease
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Time frame: Baseline and up to 96 weeks
Disease co-morbidities
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Time frame: Baseline, and up to 96 weeks
Alcohol use
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Time frame: Baseline, and up to 96 weeks
Changes in Model for End-Stage Liver Disease (MELD) score
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Time frame: Baseline, and up to 96 weeks
Safety laboratory (biochemistry and haematology) parameters
11 secondary outcomes
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Time frame: Screening up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Time frame: Screening up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Time frame: Screening up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Time frame: Screening up to 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Resolution Therapeutics Limited at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine the characteristics of patients admitted to hospital with hepatic decompensation. (time frame: Baseline and up to 96 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.