Liver CirrhosisNCT03202498
Safety and Tolerability of Yaq-001 in Patients With Cirrhosis
A study testing 4g Yaq-001 and 8g Yaq-001 in people with Liver Cirrhosis, run by Yaqrit Ltd at 9 sites in 6 countries.
Trial summary
In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut into the blood and cause harm. This study looks into a new way to lower the leakage of bacterial fragments into the blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- 4g Yaq-001 and 8g Yaq-001
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 28 Feb 2019to 26 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- Age ≥ 18 years at screening
- Clinical diagnosis of cirrhosis for any cause. Liver biopsy is not required
- Cirrhotic patients with diuretic-responsive ascites and Child-Pugh score = 7-11 inclusive
- Abstinence from alcohol for at least 4 weeks prior to screening
Who cannot join
- Refusal or inability (lack of capacity) to give informed consent
- Prohibited medication within 4 weeks before the start of the study treatment: all oral antibiotics, immunosuppressants, long acting benzodiazepines or barbiturates and antiviral medication
- Change in dose of proton pump inhibitor therapy within 4 weeks before the start of the study treatment
- Patients with once daily medications in which orocaecal transit time is greater than 10 hours
- Patients requiring medication in which the dosing schedule is three times per day or greater
- Antiviral therapy for hepatitis C within 3 months prior to screening
Show all 16Show fewer
- Hospital admission for liver-related indication for at least 4 weeks (except paracentesis)
- BMI > 35 or BMI < 18
- Clostridium Difficile diarrhoea within 4 weeks before the start of the study treatment
- Uncontrolled infection (chronic viral hepatitis is not an exclusion criterion)
- Human immunodeficiency virus
- Presence of a transjugular intrahepatic portosystemic shunt (TIPSS)
- Participation in any clinical study of an investigational medicinal product within 30 days of five half-lives of the investigational product, whichever is longer
- Presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, renal, hepatic, metabolic, haematological, neurological, psychiatric, systemic, ocular, gynaecologic or any acute infection disease or signs of acute illness that, in the opinion of the investigator, might compromise the patient's safe participation in the trial and/or results in a WHO performance status of 2 or more.
- Presence of the history of cancer within the past 5 years with exception of hepatocellular carcinoma within Milan criteria, adequately treated localised basal cell carcinoma of the skin, in situ cervical carcinoma or solid malignancy surgical excised in total without recurrence for five years.
- Women of child bearing potential. Only postmenopausal women or with surgical sterilization will be included.
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Spain3 sites
Hospital Vall d'Hebron, Liver Unit
Barcelona, 08035
Hospital Clinic of Barcelona , Liver Unit,
Barcelona, 08036
Hospital Ramon y Cajal, Department of Gastroenterology and Hepatology
Madrid, 28034
Italy2 sites
Policlinico S.Orsola Malpighi, Department of Medical and Surgical Sciences
Bologna, 40138
Azienda Ospedaliera di Padova, Hepatic Emergencies Unit
Padova, 35128
France1 site
Hospital Beaujon, Hepatology and Liver Intensive Care,
Clichy, 82110
Switzerland1 site
Inselspital Universitaet Bern, Department for Visceral Surgery and Medicine,
Bern, 3010
United Kingdom1 site
Royal Free Hospital, Institute of Liver and Digestive Disease
London, NW3 2PF
About this study
Official title: Safety and Tolerability of Yaq-001 in Patients With Cirrhosis ("CARBALIVE-SAFETY")
In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut into the blood and cause harm. This study looks into a new way to lower the leakage of bacterial fragments into the blood.
Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have the ability to bind these bacterial fragments and so confine them to the gut. The purpose of this clinical trial is to test the product Yaq-001 for the first time in patients with cirrhosis.
Read more
This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it helps improve the overall health status of the cirrhotic patients.
Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis for any cause. Only postmenopausal women or with surgical sterilisation are eligible. Additional inclusion and exclusion criteria of medical nature will be determined with the investigator at the screening visit, by means of standard care routines plus an additional test to assess the bowel transit time.
Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001, or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to better understand how safe and tolerable Yaq-001 really is.
The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study doctor 5 times. At all the visits the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital.
56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.
Read the detailed description
First-in-human clinical investigation with Yaq-001. This is a multicentre, randomized, double blinded, placebo controlled trial to intended to evaluate safety and tolerability of oral administration of Yaq-001 therapy in two dosing cohorts.
56 cirrhotic patients with diuretic-responsive ascites will be enrolled. Patients will be randomized to two dosing cohorts.
Cohort 1 (1:1 randomization)
- Standard medical treatment + Yaq-001 (4 g/ day) - n= 14.
- Standard medical treatment + placebo-control (placebo for 4 g of Yaq-001/ day) - n= 14.
Cohort 2 (1:1 randomization)
- Standard medical treatment + Yaq-001 (8 g/ day) - n= 14.
- Standard medical treatment + placebo-control (placebo for 8 g of Yaq-001/ day) - n= 14.
Study patients will be dosed daily with Yaq-001 (or an equivalent quantity of placebo) for 12 weeks. Assessments of DSMB will take place after 4 and 12 weeks. Investigational centres specialized in the management of patients with liver cirrhosis will participate in the study.
For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
The total study duration is estimated to be approximately 6 months from screening of first patient until study completion of the last patient.
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 634579.
- Conditions
- Liver Cirrhosis
- Being tested
- 4g Yaq-001, 4g Placebo, 8g Yaq-001, 8g Placebo
- Keywords
- Cirrhosis, Liver, Fibrosis, Liver, Hepatic Cirrhosis, Liver Fibrosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4g Yaq-001Device
Study patients will be dosed daily with 4g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
4g PlaceboOther
Study patients will be dosed daily with a quantity of placebo equivalent to 4g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
8g Yaq-001Device
Study patients will be dosed daily with 8g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
8g PlaceboOther
Study patients will be dosed daily with a quantity of placebo equivalent to 8g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (4g Yaq-001) | Experimental | Standard medical treatment + Yaq-001 (4 g/ day) Receives: Device: 4g Yaq-001 |
| Cohort 1 (4g Placebo) | Placebo comparator | Standard medical treatment + placebo-control (placebo for 4 g of Yaq-001/ day) Receives: Other: 4g Placebo |
| Cohort 2 (8g Yaq-001) | Experimental | Standard medical treatment + Yaq-001 (8 g/ day) Receives: Device: 8g Yaq-001 |
| Cohort 2 (8g Placebo) | Placebo comparator | Standard medical treatment + placebo-control (placebo for 8 g of Yaq-001/ day) Receives: Other: 8g Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of reported and observed Serious Adverse Events
The percentage of patients experiencing SAEs will be tabulated by arm.
Measured: Day 1
Assessment of treatment-related Serious Adverse Events
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Measured: Day 1
Assessment of withdrawals due to Adverse Events
The percentage of patients who withdraw due to an AE will be tabulated by arm.
Measured: Day 1
Assessment of reported and observed Serious Adverse Events
The percentage of patients experiencing SAEs will be tabulated by arm.
Measured: Week 1
Assessment of treatment-related Serious Adverse Events
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Measured: Week 1
Assessment of withdrawals due to Adverse Events
The percentage of patients who withdraw due to an AE will be tabulated by arm.
Measured: Week 1
Assessment of reported and observed Serious Adverse Events
The percentage of patients experiencing SAEs will be tabulated by arm.
Measured: Week 4
Assessment of treatment-related Serious Adverse Events
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Measured: Week 4
Assessment of withdrawals due to Adverse Events
The percentage of patients who withdraw due to an AE will be tabulated by arm.
Measured: Week 4
Assessment of reported and observed Serious Adverse Events
The percentage of patients experiencing SAEs will be tabulated by arm.
Measured: Week 8
Assessment of treatment-related Serious Adverse Events
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Measured: Week 8
Assessment of withdrawals due to Adverse Events
The percentage of patients who withdraw due to an AE will be tabulated by arm
Measured: Week 8
Assessment of reported and observed Adverse Events
The percentage of patients experiencing SAEs will be tabulated by arm.
Measured: Week 12
Assessment of treatment-related Serious Adverse Events
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Measured: Week 12
Assessment of withdrawals due to Adverse Events
The percentage of patients who withdraw due to an AE will be tabulated by arm.
Measured: Week 12
Secondary outcomes (4)
Assessment of changes in blood endotoxin activity
The changes from baseline in blood endotoxin activity, measured by the EAA, will be used as device-related performance indicator.
Measured: The EAA will be performed at randomization, 1-week, 4-week, 8-week and 12-week visits.
Assessment of changes in organ function as per the CHILD-PUGH score
Changes from baseline in kidney, liver, brain, intestinal and immune functions will be assessed by means of the CHILD-PUGH score.
Measured: CHILD-PUGH scores will be calculated at screening, randomization, 1-week, 4-week, 8-week and 12-week visits.
Assessment of changes in organ function as per the MELD score
Changes from baseline in kidney, liver, brain, intestinal and immune functions will be assessed by means of the MELD score.
Measured: MELD scores will be calculated at screening, randomization, 1-week, 4-week, 8-week and 12-week visits.
Assessment of changes in nutritional status
Changes from baseline in nutritional status be assessed by means of the global assessment score (RFH-GA);
Measured: Global assessment will be performed at randomization, 1-week, 4-week, 8-week and 12-week visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start28 Feb 2019
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Why it stopped: COVID-19 pandemic prevents patients from making in-hospital visits, which are mandatory to assessment of safety in this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cohort 1 (1:1 randomization): Standard medical treatment + Yaq-001 (4 g/ day) - n= 14. Standard medical treatment + placebo-control (placebo for 4 g of Yaq-001/ day) - n= 14. Cohort 2 (1:1 randomization): Standard medical treatment + Yaq-001 (8 g/ day) - n= 14. Standard medical treatment + placebo-control (placebo for 8 g of Yaq-001/ day) - n= 14.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaqrit Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College, London, University of Brighton, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Azienda Ospedaliera di Padova, Hospital Universitari Vall d'Hebron Research Institute, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Lisbon, Servicio Madrileño de Salud, Madrid, Spain, University of Bern, Assistance Publique - Hôpitaux de Paris, A2F Associates Limited, Alpha Bioresearch S.L.
- Responsible party
- Sponsor
- Investigators
- Rajiv Jalan, Study chair, Head, Liver Failure Group ILDH, Division of Medicine UCL Medical School Royal Free Campus Rowland Hill Street London NW32PFJane Macnaughtan, Study director, Consultant, Liver Failure Group, ILDH, Division of Medicine UCL Medical School Royal Free Campus Rowland Hill Street London NW32PF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202498
- Sponsor's protocol ID
- Yaq001-S-001
- Status last verified
- Oct 2019
- First submitted
- 5 Apr 2017
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu J, MacNaughtan J, Kerbert AJC, Portlock T, Martinez Gonzalez J, Jin Y, Clasen F, Habtesion A, Ji H, Jin Q, Phillips A, De Chiara F, Ingavle G, Jimenez C, Zaccherini G, Husi K, Rodriguez Gandia MA, Cordero P, Soeda J, McConaghy L, Oben J, Church K, Li JV, Wu H, Jalan A, Gines P, Sola E, Eaton S, Morgan C, Kowalski M, Green D, Gander A, Edwards LA, Cox IJ, Cortez-Pinto H, Avery T, Wiest R, Durand F, Caraceni P, Elosua R, Vila J, Pavesi M, Arroyo V, Davies N, Mookerjee RP, Vargas V, Sandeman S, Mehta G, Shoaie S, Marchesi J, Albillos A, Andreola F, Jalan R. Clinical, experimental and pathophysiological effects of Yaq-001: a non-absorbable, gut-restricted adsorbent in models and patients with cirrhosis. Gut. 2024 Jun 6;73(7):1183-1198. doi: 10.1136/gutjnl-2023-330699.
PubMed 38621924
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Yaq-001 in Patients With Cirrhosis ("CARBALIVE-SAFETY")
- ClinicalTrials.gov ID
- NCT03202498
- Acronym / sponsor ID
- Yaq001-S-001
- Conditions
- Liver Cirrhosis
- Keywords
- Cirrhosis, Liver, Fibrosis, Liver, Hepatic Cirrhosis, Liver Fibrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic prevents patients from making in-hospital visits, which are mandatory to assessment of safety in this study
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yaqrit LtdIndustry (pharma, biotech, devices)
- Collaborators
- University College, London, University of Brighton, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Azienda Ospedaliera di Padova, Hospital Universitari Vall d'Hebron Research Institute, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Lisbon, Servicio Madrileño de Salud, Madrid, Spain, University of Bern, Assistance Publique - Hôpitaux de Paris, A2F Associates Limited, Alpha Bioresearch S.L.
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 28 Jun 2017 (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.
In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut into the blood and cause harm. This study looks into a new way to lower the leakage of bacterial fragments into the blood.
Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have the ability to bind these bacterial fragments and so confine them to the gut. The purpose of this clinical trial is to test the product Yaq-001 for the first time in patients with cirrhosis.
This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it helps improve the overall health status of the cirrhotic patients.
Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis for any cause. Only postmenopausal women or with surgical sterilisation are eligible. Additional inclusion and exclusion criteria of medical nature will be determined with the investigator at the screening visit, by means of standard care routines plus an additional test to assess the bowel transit time.
Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001, or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to better understand how safe and tolerable Yaq-001 really is.
The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study doctor 5 times. At all the visits the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital.
56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.
Detailed description
First-in-human clinical investigation with Yaq-001. This is a multicentre, randomized, double blinded, placebo controlled trial to intended to evaluate safety and tolerability of oral administration of Yaq-001 therapy in two dosing cohorts.
56 cirrhotic patients with diuretic-responsive ascites will be enrolled. Patients will be randomized to two dosing cohorts.
Cohort 1 (1:1 randomization)
- Standard medical treatment + Yaq-001 (4 g/ day) - n= 14.
- Standard medical treatment + placebo-control (placebo for 4 g of Yaq-001/ day) - n= 14.
Cohort 2 (1:1 randomization)
- Standard medical treatment + Yaq-001 (8 g/ day) - n= 14.
- Standard medical treatment + placebo-control (placebo for 8 g of Yaq-001/ day) - n= 14.
Study patients will be dosed daily with Yaq-001 (or an equivalent quantity of placebo) for 12 weeks. Assessments of DSMB will take place after 4 and 12 weeks. Investigational centres specialized in the management of patients with liver cirrhosis will participate in the study.
For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
The total study duration is estimated to be approximately 6 months from screening of first patient until study completion of the last patient.
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 634579.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Cohort 1 (1:1 randomization): Standard medical treatment + Yaq-001 (4 g/ day) - n= 14. Standard medical treatment + placebo-control (placebo for 4 g of Yaq-001/ day) - n= 14. Cohort 2 (1:1 randomization): Standard medical treatment + Yaq-001 (8 g/ day) - n= 14. Standard medical treatment + placebo-control (placebo for 8 g of Yaq-001/ day) - n= 14.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (4g Yaq-001) | Experimental | Device: 4g Yaq-001Standard medical treatment + Yaq-001 (4 g/ day) |
| Cohort 1 (4g Placebo) | Placebo comparator | Other: 4g PlaceboStandard medical treatment + placebo-control (placebo for 4 g of Yaq-001/ day) |
| Cohort 2 (8g Yaq-001) | Experimental | Device: 8g Yaq-001Standard medical treatment + Yaq-001 (8 g/ day) |
| Cohort 2 (8g Placebo) | Placebo comparator | Other: 8g PlaceboStandard medical treatment + placebo-control (placebo for 8 g of Yaq-001/ day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients
- Age ≥ 18 years at screening
- Clinical diagnosis of cirrhosis for any cause. Liver biopsy is not required
- Cirrhotic patients with diuretic-responsive ascites and Child-Pugh score = 7-11 inclusive
- Abstinence from alcohol for at least 4 weeks prior to screening
Key exclusion criteria (16 listed)
- Refusal or inability (lack of capacity) to give informed consent
- Prohibited medication within 4 weeks before the start of the study treatment: all oral antibiotics, immunosuppressants, long acting benzodiazepines or barbiturates and antiviral medication
- Change in dose of proton pump inhibitor therapy within 4 weeks before the start of the study treatment
- Patients with once daily medications in which orocaecal transit time is greater than 10 hours
- Patients requiring medication in which the dosing schedule is three times per day or greater
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4g Yaq-001Study patients will be dosed daily with 4g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period. | Device | Cohort 1 (4g Yaq-001) |
| 4g PlaceboStudy patients will be dosed daily with a quantity of placebo equivalent to 4g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period. | Other | Cohort 1 (4g Placebo) |
| 8g Yaq-001Study patients will be dosed daily with 8g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period. | Device | Cohort 2 (8g Yaq-001) |
| 8g PlaceboStudy patients will be dosed daily with a quantity of placebo equivalent to 8g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period. | Other | Cohort 2 (8g Placebo) |
Primary outcome
Assessment of reported and observed Serious Adverse Events
Time frame: Day 1
The percentage of patients experiencing SAEs will be tabulated by arm.
Assessment of treatment-related Serious Adverse Events
Time frame: Day 1
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Assessment of withdrawals due to Adverse Events
Time frame: Day 1
The percentage of patients who withdraw due to an AE will be tabulated by arm.
Assessment of reported and observed Serious Adverse Events
Time frame: Week 1
The percentage of patients experiencing SAEs will be tabulated by arm.
Assessment of treatment-related Serious Adverse Events
Time frame: Week 1
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Assessment of withdrawals due to Adverse Events
Time frame: Week 1
The percentage of patients who withdraw due to an AE will be tabulated by arm.
Assessment of reported and observed Serious Adverse Events
Time frame: Week 4
The percentage of patients experiencing SAEs will be tabulated by arm.
Assessment of treatment-related Serious Adverse Events
Time frame: Week 4
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Assessment of withdrawals due to Adverse Events
Time frame: Week 4
The percentage of patients who withdraw due to an AE will be tabulated by arm.
Assessment of reported and observed Serious Adverse Events
Time frame: Week 8
The percentage of patients experiencing SAEs will be tabulated by arm.
Assessment of treatment-related Serious Adverse Events
Time frame: Week 8
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Assessment of withdrawals due to Adverse Events
Time frame: Week 8
The percentage of patients who withdraw due to an AE will be tabulated by arm
Assessment of reported and observed Adverse Events
Time frame: Week 12
The percentage of patients experiencing SAEs will be tabulated by arm.
Assessment of treatment-related Serious Adverse Events
Time frame: Week 12
The percentage of patients experiencing device-related SAEs will be tabulated by arm.
Assessment of withdrawals due to Adverse Events
Time frame: Week 12
The percentage of patients who withdraw due to an AE will be tabulated by arm.
4 secondary outcomes
Assessment of changes in blood endotoxin activity
Time frame: The EAA will be performed at randomization, 1-week, 4-week, 8-week and 12-week visits.
Assessment of changes in organ function as per the CHILD-PUGH score
Time frame: CHILD-PUGH scores will be calculated at screening, randomization, 1-week, 4-week, 8-week and 12-week visits.
Assessment of changes in organ function as per the MELD score
Time frame: MELD scores will be calculated at screening, randomization, 1-week, 4-week, 8-week and 12-week visits.
Assessment of changes in nutritional status
Time frame: Global assessment will be performed at randomization, 1-week, 4-week, 8-week and 12-week visits.
Results and safety
The study was stopped early (reason given: COVID-19 pandemic prevents patients from making in-hospital visits, which are mandatory to assessment of safety in this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Derived from this study: PubMed 38621924Liu J, MacNaughtan J, Kerbert AJC, Portlock T, Martinez Gonzalez J, Jin Y, Clasen F, Habtesion A, Ji H, Jin Q, Phillips A, De Chiara F, Ingavle G, Jimenez C, Zaccherini G, Husi K, Rodriguez Gandia MA, Cordero P, Soeda J, McConaghy L, Oben J, Church K, Li JV, Wu H, Jalan A, Gines P, Sola E, Eaton S, Morgan C, Kowalski M, Green D, Gander A, Edwards LA, Cox IJ, Cortez-Pinto H, Avery T, Wiest R, Durand F, Caraceni P, Elosua R, Vila J, Pavesi M, Arroyo V, Davies N, Mookerjee RP, Vargas V, Sandeman S, Mehta G, Shoaie S, Marchesi J, Albillos A, Andreola F, Jalan R. Clinical, experimental and pathophysiological effects of Yaq-001: a non-absorbable, gut-restricted adsorbent in models and patients with cirrhosis. Gut. 2024 Jun 6;73(7):1183-1198. doi: 10.1136/gutjnl-2023-330699.
- Individual participant dataSharing planned: No
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Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Rajiv Jalan study chair
Head, Liver Failure Group ILDH, Division of Medicine UCL Medical School Royal Free Campus Rowland Hill Street London NW32PF
Jane Macnaughtan study director
Consultant, Liver Failure Group, ILDH, Division of Medicine UCL Medical School Royal Free Campus Rowland Hill Street London NW32PF
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4g Yaq-001 and 8g Yaq-001 in people with Liver Cirrhosis, run by Yaqrit Ltd at 9 sites in 6 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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Italy, France, Portugal, Switzerland and 1 more country. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: COVID-19 pandemic prevents patients from making in-hospital visits, which are mandatory to assessment of safety in this study). Results are not available in the source record.
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?
Assessment of reported and observed Serious Adverse Events (time frame: Day 1). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03202498, which also lists 1 linked publication.
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 25 Aug 2020.