Safety and tolerability of Yaq-001 in patients with cirrhosis

Not Applicable

Completed

• Conditions: Cirrhosis with diuretic-responsive ascites; Digestive System

• Registration Number: ISRCTN16926948
• Lead Sponsor: Yaqrit Ltd

Brief Summary

2021 Abstract results in http://dx.doi.org/10.1136/gutjnl-2021-BASL.9 (added 18/02/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-22
• Study Completion: 2020-08-30
• Last Update Posted: 1 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Male and female patients
2. Aged 18 years old or older 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 result 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety is assessed using a physical examination, vital signs (blood pressure, pulse rate, respiratory rate and body temperature), clinical laboratory tests (haematology, coagulation, clinical chemistry and urinalysis), 12-lead ECG and reported./observed adverse events at baseline and weeks 1, 4, 8 and 12.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Changes in blood endotoxin activity is measured using the Endotoxin Activity Assay (EAA) at baseline and weeks 1, 4, 8 and 12.<br> 2. Changes in organ function (kidney, liver, brain, intestinal and immune functions) are assessed using:<br> 2.1. CHILD-PUGH score at baseline and weeks 1, 4, 8 and 12<br> 2.2. MELD score at baseline and weeks 1, 4, 8 and 12<br> 2.3. Clinical laboratory tests at baseline and weeks 4 and 12<br> 3. Nutritional status is measured using:<br> 3.1. Global assessment (RFH-GA) at baseline and weeks 1, 4, 8 and 12<br> 3.2. Clinical laboratory tests at baseline and weeks 4 and 12<br>