Clinical trial • Phase III • Gastroenterology
ZINC ACEXAMATE for Advanced chronic liver disease | Chronic liver disease
Phase III trial of ZINC ACEXAMATE for Advanced chronic liver disease | Chronic liver disease.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Advanced chronic liver disease | Chronic liver disease
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-10-2024
- First CTIS Authorization Date
- 18-10-2024
Trial design
Randomised, placebo: 'placebo has the same composition than imp except the active substance' used as comparator. active product: zinc acexamate (copinal 300 mg cápsulas) administered 600 mg/day (equivalent to 100 mg/day elemental zinc).-controlled Phase III trial across 15 sites in Spain.
- Randomised
- Yes
- Comparator
- Placebo: 'Placebo has the same composition than imp except the active substance' used as comparator. Active product: Zinc Acexamate (COPINAL 300 mg cápsulas) administered 600 mg/day (equivalent to 100 mg/day elemental zinc).
- Target Sample Size
- 300
Eligibility
Recruits 300 Vulnerable population not selected. Participants must be adults aged 18 to 80 and must sign informed consent. No assent procedures or paediatric/other vulnerable-consent arrangements are described..
- Pregnancy Exclusion
- Pregnancy, breastfeeding, or refusal to use contraceptive measures whilst participating in the study.
- Vulnerable Population
- Vulnerable population not selected. Participants must be adults aged 18 to 80 and must sign informed consent. No assent procedures or paediatric/other vulnerable-consent arrangements are described.
Inclusion criteria
- {"criterion_text":"- Patients of both sexes with cACLD diagnosed by hepatic stiffness by transition elastography >15 kPa.\n- Age between 18 and 80 years, both inclusive.\n- Absence of previous or current decompensation.\n- In women of childbearing age, a possible pregnancy will be ruled out by means of a pregnancy test prior to the start of the study. Once the test has been carried out, the woman must use an effective contraceptive method during sexual intercourse to be maintained from the days prior to the start of treatment, and will continue to use them while the treatment is ongoing, as well as until a few days after finishing it.\n- Sign the informed consent."}
Exclusion criteria
- {"criterion_text":"- History or current presence of hepatocarcinoma.\n- Concomitant systemic disease, with low short-term prognosis for life.\n- Pregnancy, breastfeeding, or refusal to use contraceptive measures whilst participating in the study.\n- Patients with cACLD due to HBV on antiviral treatment and with cACLD due to HCV cured with antiviral treatment."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of time-dependent clinical events during study follow-up, along with the distribution of CSPH risk estimated by the ANTICIPATE model. Clinical events are defined as the sum of: 1. Hepatic decompensation defined as the presence of clinical ascites, gastrointestinal bleeding due to portal hypertension, and hepatic encephalopathy. 2. Hepatocellular carcinoma. 3. Death from liver causes (considering non-hepatic death as a competitive risk). 4. Liver transplant.","definition_or_measurement_approach":"Measured as time-dependent occurrence of the listed clinical events during study follow-up; CSPH risk distribution estimated by the ANTICIPATE model. Clinical events are the composite of hepatic decompensation (clinical ascites, GI bleeding due to portal hypertension, hepatic encephalopathy), hepatocellular carcinoma, liver-related death (non-hepatic death as competing risk), and liver transplant."}
Recruitment
- Planned Sample Size
- 300
- Recruitment Window Months
- 66
- Consent Approach
- Participants (adults 18-80) must sign informed consent. Subject information and informed consent forms are provided (documents listed: L1_SIS General_ESP_for publication, L1_ICF General_ESP_for publication) indicating Spanish-language materials are available. No assent procedures described for minors (minors are excluded).
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 300
Spain
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 596
- Number Of Sites
- 15
- Number Of Participants
- 300
Sites
- Site Name
- Hospital Del Mar
- Department Name
- Hepatology Section, Department of Gastroenterology
- Principal Investigator Name
- Montserrat García
- Principal Investigator Email
- mgarciaretortillo@psmar.cat
- Contact Person Name
- Montserrat García
- Contact Person Email
- mgarciaretortillo@psmar.cat
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Digestive System Service
- Principal Investigator Name
- Jordi Sánchez
- Principal Investigator Email
- jsanchezd@tauli.cat
- Contact Person Name
- Jordi Sánchez
- Contact Person Email
- jsanchezd@tauli.cat
- Site Name
- Bellvitge University Hospital
- Department Name
- Hepatology and Liver Transplant Unit Section. Digestive System
- Principal Investigator Name
- Alberto Amador
- Principal Investigator Email
- Alberto.navarrete@bellvitgehospital.cat
- Contact Person Name
- Alberto Amador
- Contact Person Email
- Alberto.navarrete@bellvitgehospital.cat
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Digestive System Service
- Principal Investigator Name
- Carmen Álvarez
- Principal Investigator Email
- mariacarmen.alvarezn@sespa.es
- Contact Person Name
- Carmen Álvarez
- Contact Person Email
- mariacarmen.alvarezn@sespa.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Digestive System Service
- Principal Investigator Name
- Vanesa Bernal
- Principal Investigator Email
- vbernal@salud.aragon.es
- Contact Person Name
- Vanesa Bernal
- Contact Person Email
- vbernal@salud.aragon.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Gastroenterology and Hepatology Service
- Principal Investigator Name
- Agustín Albillos
- Principal Investigator Email
- agustin.albillos@uah.es
- Contact Person Name
- Agustín Albillos
- Contact Person Email
- agustin.albillos@uah.es
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Digestive System Service
- Principal Investigator Name
- Marta Romero
- Principal Investigator Email
- mromerog@sescam.jccm.es
- Contact Person Name
- Marta Romero
- Contact Person Email
- mromerog@sescam.jccm.es
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Digestive System Service
- Principal Investigator Name
- María Valenzuela
- Principal Investigator Email
- mvalenzuela.girona.ics@gencat.cat
- Contact Person Name
- María Valenzuela
- Contact Person Email
- mvalenzuela.girona.ics@gencat.cat
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Digestive System Service
- Principal Investigator Name
- Rosa María Morillas
- Principal Investigator Email
- rmorillas.germanstrias@gencat.cat
- Contact Person Name
- Rosa María Morillas
- Contact Person Email
- rmorillas.germanstrias@gencat.cat
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Digestive System Medicine Service
- Principal Investigator Name
- Rafael Bañares
- Principal Investigator Email
- rbanares@ucm.es
- Contact Person Name
- Rafael Bañares
- Contact Person Email
- rbanares@ucm.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hepatology Service
- Principal Investigator Name
- Joan Genescà
- Principal Investigator Email
- jgenesca@vhebron.net
- Contact Person Name
- Joan Genescà
- Contact Person Email
- jgenesca@vhebron.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hepatology Service
- Principal Investigator Name
- Fanny Turon
- Principal Investigator Email
- fturon@clinic.cat
- Contact Person Name
- Fanny Turon
- Contact Person Email
- fturon@clinic.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Gastroenterology and Hepatology Service
- Principal Investigator Name
- Anna Brujats
- Principal Investigator Email
- abrujats@santpau.cat
- Contact Person Name
- Anna Brujats
- Contact Person Email
- abrujats@santpau.cat
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Gastroenterology and Hepatology Service
- Principal Investigator Name
- Angela Puente
- Principal Investigator Email
- angelam.puente@scsalud.es
- Contact Person Name
- Angela Puente
- Contact Person Email
- angelam.puente@scsalud.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Gastroenterology and Hepatology Unit
- Principal Investigator Name
- José Luís Calleja
- Principal Investigator Email
- joseluis.calleja@uam.es
- Contact Person Name
- José Luís Calleja
- Contact Person Email
- joseluis.calleja@uam.es
Sponsor
Primary sponsor
- Full Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- COPINAL 300 mg cápsulas
- Active Substance
- ZINC ACEXAMATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised (marketing authorisation number 56.926 in Spain)
- Starting Dose
- 600 mg/day
- Dose Levels
- 600 mg/day
- Frequency
- daily
- Maximum Dose
- 600 mg/day
- Investigational Product Name
- Placebo has the same composition than imp except the active substance
- Modality
- Other
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