Liver Cirrhosis Clinical Trial
Official title:
Safety and Tolerability of Yaq-001 in Patients With Cirrhosis ("CARBALIVE-SAFETY")
Verified date | October 2019 |
Source | Yaqrit Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 31 |
Est. completion date | March 26, 2020 |
Est. primary completion date | March 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Male and female patients 2. Age = 18 years at screening 3. Clinical diagnosis of cirrhosis for any cause. Liver biopsy is not required 4. Cirrhotic patients with diuretic-responsive ascites and Child-Pugh score = 7-11 inclusive 5. Abstinence from alcohol for at least 4 weeks prior to screening Exclusion Criteria: 1. Refusal or inability (lack of capacity) to give informed consent 2. Prohibited medication within 4 weeks before the start of the study treatment: all oral antibiotics, immunosuppressants, long acting benzodiazepines or barbiturates and antiviral medication 3. Change in dose of proton pump inhibitor therapy within 4 weeks before the start of the study treatment 4. Patients with once daily medications in which orocaecal transit time is greater than 10 hours 5. Patients requiring medication in which the dosing schedule is three times per day or greater 6. Antiviral therapy for hepatitis C within 3 months prior to screening 7. Hospital admission for liver-related indication for at least 4 weeks (except paracentesis) 8. BMI > 35 or BMI < 18 9. Clostridium Difficile diarrhoea within 4 weeks before the start of the study treatment 10. Uncontrolled infection (chronic viral hepatitis is not an exclusion criterion) 11. Human immunodeficiency virus 12. Presence of a transjugular intrahepatic portosystemic shunt (TIPSS) 13. Participation in any clinical study of an investigational medicinal product within 30 days of five half-lives of the investigational product, whichever is longer 14. 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. 15. 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. 16. Women of child bearing potential. Only postmenopausal women or with surgical sterilization will be included. |
Country | Name | City | State |
---|---|---|---|
France | Hospital Beaujon, Hepatology and Liver Intensive Care, | Clichy | |
Italy | Policlinico S.Orsola Malpighi, Department of Medical and Surgical Sciences | Bologna | |
Italy | Azienda Ospedaliera di Padova, Hepatic Emergencies Unit | Padova | |
Portugal | University Hospital of Santa Maria | Lisbon | |
Spain | Hospital Clinic of Barcelona , Liver Unit, | Barcelona | |
Spain | Hospital Vall d'Hebron, Liver Unit | Barcelona | |
Spain | Hospital Ramon y Cajal, Department of Gastroenterology and Hepatology | Madrid | |
Switzerland | Inselspital Universitaet Bern, Department for Visceral Surgery and Medicine, | Bern | |
United Kingdom | Royal Free Hospital, Institute of Liver and Digestive Disease | London |
Lead Sponsor | Collaborator |
---|---|
Yaqrit Ltd | A2F Associates Limited, Alpha Bioresearch S.L., Assistance Publique - Hôpitaux de Paris, Azienda Ospedaliera di Padova, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi, Hospital Universitari Vall d'Hebron Research Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Servicio Madrileño de Salud, Madrid, Spain, University College, London, University of Bern, University of Brighton, University of Lisbon |
France, Italy, Portugal, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of reported and observed Serious Adverse Events | The percentage of patients experiencing SAEs will be tabulated by arm. | Day 1 | |
Primary | Assessment of treatment-related Serious Adverse Events | The percentage of patients experiencing device-related SAEs will be tabulated by arm. | Day 1 | |
Primary | Assessment of withdrawals due to Adverse Events | The percentage of patients who withdraw due to an AE will be tabulated by arm. | Day 1 | |
Primary | Assessment of reported and observed Serious Adverse Events | The percentage of patients experiencing SAEs will be tabulated by arm. | Week 1 | |
Primary | Assessment of treatment-related Serious Adverse Events | The percentage of patients experiencing device-related SAEs will be tabulated by arm. | Week 1 | |
Primary | Assessment of withdrawals due to Adverse Events | The percentage of patients who withdraw due to an AE will be tabulated by arm. | Week 1 | |
Primary | Assessment of reported and observed Serious Adverse Events | The percentage of patients experiencing SAEs will be tabulated by arm. | Week 4 | |
Primary | Assessment of treatment-related Serious Adverse Events | The percentage of patients experiencing device-related SAEs will be tabulated by arm. | Week 4 | |
Primary | Assessment of withdrawals due to Adverse Events | The percentage of patients who withdraw due to an AE will be tabulated by arm. | Week 4 | |
Primary | Assessment of reported and observed Serious Adverse Events | The percentage of patients experiencing SAEs will be tabulated by arm. | Week 8 | |
Primary | Assessment of treatment-related Serious Adverse Events | The percentage of patients experiencing device-related SAEs will be tabulated by arm. | Week 8 | |
Primary | Assessment of withdrawals due to Adverse Events | The percentage of patients who withdraw due to an AE will be tabulated by arm | Week 8 | |
Primary | Assessment of reported and observed Adverse Events | The percentage of patients experiencing SAEs will be tabulated by arm. | Week 12 | |
Primary | Assessment of treatment-related Serious Adverse Events | The percentage of patients experiencing device-related SAEs will be tabulated by arm. | Week 12 | |
Primary | Assessment of withdrawals due to Adverse Events | The percentage of patients who withdraw due to an AE will be tabulated by arm. | Week 12 | |
Secondary | 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. | The EAA will be performed at randomization, 1-week, 4-week, 8-week and 12-week visits. | |
Secondary | 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. | CHILD-PUGH scores will be calculated at screening, randomization, 1-week, 4-week, 8-week and 12-week visits. | |
Secondary | 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. | MELD scores will be calculated at screening, randomization, 1-week, 4-week, 8-week and 12-week visits. | |
Secondary | Assessment of changes in nutritional status | Changes from baseline in nutritional status be assessed by means of the global assessment score (RFH-GA); | Global assessment will be performed at randomization, 1-week, 4-week, 8-week and 12-week visits. |
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