Revisions for Hepatotoxicity by drugs | Registro Público Cubano de Ensayos Clínicos

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Revision of 9 August 2019 - 1:57pm:

Hepatotoxicity by drugs

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Epidemiology and factors associated with drug hepatotoxicity in patients at IPS Universitaria Clínica León XIII

Secondary indentifying numbers:

IN11-2015

Issuing authority of the secondary identifying numbers:

Institution of Health Services for the University of Antioquia (IPS Universitaria Leon XIII Clinic)

Source(s) of monetary or material support:

University of Antioquia (UdeA) Institution of Health Services for the University of Antioquia (IPS Universitaria Leon XIII Clinic)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Pedro

Midle name:

Jose

Last name:

Amariles Muñoz

Medical Specialty :

Pharmaceutical Chemist

Affiliation:

University of Antioquia

Postal address:

Calle 70 No. 52 - 21

City:

Medellin

Country:

Colombia

Zip Code:

1226

Telephone:

+57-5742195460

Email address:

pedro.amariles@udea.edu.co

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Colombia

Clinical sites:

Medellin, IPS Universitaria Leon XIII Clinic, Alejandra Cano. Pharmaceutical Chemist

Research ethics committees:

Bioethics committee IPS Universitaria, July 31, 2015

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

04/11/2015

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Hepatotoxicity

Health condition(s) code:

Drug-Induced Liver Injury

Liver Diseases

Digestive System Diseases

Intervention(s):

No intervention apply After the signed of informed consent, patient data is collected and analized. The Roussel Uclaf Causality Assessment Method (RUCAM) and Maria y Victorino (M&V) scales are applied to assess causality of the suspicious drug that cause hepatotoxicity.

Intervention code:

Observational Study

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Alteration of liver tests as indicator of hepatic injury (Increase of alanine aminotransferase>3 times and/or increase of alkaline phosphatase>2 times the upper limit of normal. Normal ranges for alanine aminotransferase: 10-49 U/L and alkaline phosphatase: 45-129 U/L). Measurement time: at the patient admission, monitoring between 48-72 hours during hospitalization. 2. Used drugs (identification of the active principle, concentration, trade name, dose interval, administration route). Measurement time: data collection between 6-48 hours at the patient admission and, daily monitoring on the following hospital days. 3. Use of natural products and dietary supplements (identification of the active principle, concentration, trade name, dose interval, way of administration). Measurement time: data collection between 6-48 hours at the patient admission and, daily monitored on the following hospital days.

Key secondary outcomes:

1. Age (patient’ years). Measurement time: Between 6-48 hours at the patient admission. 2. Gender (Female, Male). Measurement time: Between 6-48 hours at the patient admission. 3. Selection and location of the patient (emergency service or hospitalization service in internal consultation). Measurement time: Between 6-24 hours at the patient admission. 4. Intake of alcohol (Beer: 200 mL (5.12 g), 300 mL (7.7 g), 330 (8.5 g). Wine: 100 mL (7.2 g), 200 mL (14.4 g). Glass of liquor: 45 mL (12.6 g). Criteria for alcoholism: more than 20 g/day in women and more than 40 g/day in men). Between 6-48 hours at the patient admission. 5. Ingestion of toxic substances (psychoactive substances). Measurement time: Between 6-48 hours at the patient admission. 6. Comorbidities (names). Measurement time: Between 6-48 hours at the patient admission. 7. Extra-hepatic signs and symptoms (names). Measurement time: Between 6-48 hours at the patient admission and, daily monitoring on the following hospital days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Patients older than 18 years. 2. Presumptive identification of hepatotoxicity: patients who, upon admission to the emergency room or during hospitalization, are assigned an increase in alanine aminotransferase values greater than 3 times and/or alkaline phosphatase higher than 2 times the upper limit of normal, and the physician in charge considers that the stay in the institution is superior to 48-72 hours, due to the need to follow the reduction or elevation of the altered values and confirm the possible hepatotoxicity. 3. Patients or caregivers who authorize their participation in the study through the signing of informed consent.

Exclusion criteria:

1. Patients with an increase in ALT values greater than 3 times the ULN and / or ALP higher than 2 times the ULN for more than 6 months. 2. Patients with acute coronary syndrome. 3. Patients with terminal disease. 4. Patients with some type of neoplasm under treatment. 5. Patients with intoxications 6. Patients with alcohol consumption greater than 20 g / day in women and greater than 40 g/day in men.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Observational

Purpose:

Other

Other purpose:

Establish incidence of hepatic toxicity caused by drugs

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

Recruitment for a year since November 03, 2015

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Alejandra

Last Name:

Cano Paniagua

Specialty:

Pharmaceutical Chemist

Affiliation:

Universidad de Antioquia

Postal Address:

Calle 70 No. 52 - 21

City:

Medellín

Country:

Colombia

Zip Code:

1226

Telephone:

(57)3015511065

Email :

alejandra.canop@udea.edu.co

alecanop@gmail.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Alejandra

Last Name:

Cano Paniagua

Specialty:

Pharmaceutical Chemist

Affiliation:

Universidad de Antioquia

Postal Address:

Calle 70 No. 52 - 21

City:

Medellín

Country:

Colombia

Zip Code:

1226

Telephone:

(57)3015511065

Email :

alejandra.canop@udea.edu.co

alecanop@gmail.com

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

286

Study completion date:

17/07/2017

Date of available results:

15/08/2017

Date of first publication:

18/04/2019

Results Study

Section to complete the data related to the summarized results.

Results file:

RESULTS.pdf

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000242

Date of Registration in Primary Registry:

27/04/2017

Record Verification Date:

2019/07/29

Next update date:

2020/07/29

Link to the spanish version:

Click here

Registered Trials

Registration process

Hepatotoxicity by drugs

About the RPCEC

Useful resources