Hepatic EncephalopathyEHNCT03961087
Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy
A study testing Coenzyme Q10 and MECLOFENOXATE in people with Hepatic Encephalopathy and Coenzyme Q10, run by Zagazig University at 1 site in Egypt.
Trial summary
Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Encephalopathy, Coenzyme Q10, Intellectual Functioning Disability
- What is being tested?
- Coenzyme Q10 and MECLOFENOXATE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2019to 1 Feb 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the patients diagnosed as having liver cirrhosis Exclusion Criteria
- recent alcohol intake;
- Infection, recent antibiotic use or gastrointestinal bleeding;
- use of drugs affecting psychometric Performances like benzodiazepines, antiepileptics, psychotropic drugs
- History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension;
- Electrolyte abnormalities
Show all 9Show fewer
- Renal impairment or hepatorenal syndrome
- hepatocellular carcinoma;
- Severe medical co-morbidities that affect quality-of-life measurement as heart failure pulmonary or neurological insults.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Amr Shaaban Hanafy
Zagazig, Alsharkia, 44519
About this study
Official title: Impact of Coenzyme Q10 and Meclofenoxate on Frequency and Severity of Hepatic Encephalopathy
Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness.
Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.
Meclofenoxate is a cholinergic nootropic drug used clinically to improve memory, mental function and general cognition.
Read the detailed description
Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness. Hepatic encephalopathy is categorized into Type A hepatic encephalopathy associated with acute liver failure; Type B hepatic encephalopathy is associated with portal-systemic bypass and no intrinsic hepatocellular disease; Type C hepatic encephalopathy describes encephalopathy associated with Cirrhosis and portal hypertension; type C hepatic encephalopathy is, in turn, subcategorized as episodic, persistent, or minimal.
A number of theories had been postulated, it was proposed that hepatic encephalopathy is a disorder of astrocyte function which play a key role in the regulation of the blood-brain barrier, maintaining electrolyte homeostasis , a role in the detoxification of chemicals, including ammonia.
neurotoxic substances, including ammonia and manganese cause morphologic changes in the astrocytes leading to Alzheimer type II astrocytosis in cirrhosis.
Hepatic encephalopathy may be due to accumulated neurotoxic substances in the brain as short-chain fatty acids; mercaptans; false neurotransmitters, such as tyramine, octopamine, and beta-phenylethanolamines; manganese; ammonia; and gamma-aminobutyric acid (GABA).
Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.
Meclofenoxate is a cholinergic nootropic drug used clinically to improve memory, mental function and general cognition.
- Being tested
- Coenzyme Q10, MECLOFENOXATE
- Medical subject headings
- Hepatic Encephalopathy, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
Also called coQ10
Coenzyme Q10 will be given twice
MECLOFENOXATEDrug
Also called LUCIDREL
MECLOFENOXATE will be given as 500 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| case group | Active comparator | patients with liver cirrhosis and frequent hepatic encephalopathy received coenzyme Q10 and Meclofenoxate in addition to usual hepatic support Receives: Drug: Coenzyme Q10; Drug: MECLOFENOXATE |
| control group | No intervention | patients with liver cirrhosis and frequent hepatic encephalopathy received usual hepatic support only |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic encephalopathy
Change in the number of episodes
Measured: 6 months
health related quality of life
health related quality of life questionnaire
Measured: 6 months
hepatic detoxifying function
reduction of serum ammonia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start23 May 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients with liver cirrhosis and frequent hepatic encephalopathy (HE)
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr Shaaban Hanafy, Zagazig University
- Investigators
- Amr S Hanafy, M.D, Principal investigator, Assistant prof of medicine-Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961087
- Sponsor's protocol ID
- 5501
- Acronym
- EH
- Status last verified
- Jul 2019
- First submitted
- 21 May 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Coenzyme Q10 and Meclofenoxate on Frequency and Severity of Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT03961087
- Acronym / sponsor ID
- EH / 5501
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 23 May 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 23 May 2019 (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.
Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness.
Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.
Meclofenoxate is a cholinergic nootropic drug used clinically to improve memory, mental function and general cognition.
Detailed description
Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness. Hepatic encephalopathy is categorized into Type A hepatic encephalopathy associated with acute liver failure; Type B hepatic encephalopathy is associated with portal-systemic bypass and no intrinsic hepatocellular disease; Type C hepatic encephalopathy describes encephalopathy associated with Cirrhosis and portal hypertension; type C hepatic encephalopathy is, in turn, subcategorized as episodic, persistent, or minimal.
A number of theories had been postulated, it was proposed that hepatic encephalopathy is a disorder of astrocyte function which play a key role in the regulation of the blood-brain barrier, maintaining electrolyte homeostasis , a role in the detoxification of chemicals, including ammonia.
neurotoxic substances, including ammonia and manganese cause morphologic changes in the astrocytes leading to Alzheimer type II astrocytosis in cirrhosis.
Hepatic encephalopathy may be due to accumulated neurotoxic substances in the brain as short-chain fatty acids; mercaptans; false neurotransmitters, such as tyramine, octopamine, and beta-phenylethanolamines; manganese; ammonia; and gamma-aminobutyric acid (GABA).
Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.
Meclofenoxate is a cholinergic nootropic drug used clinically to improve memory, mental function and general cognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients with liver cirrhosis and frequent hepatic encephalopathy (HE)
| Arm | Type | Receives |
|---|---|---|
| case group | Active comparator | Drug: Coenzyme Q10, Drug: MECLOFENOXATEpatients with liver cirrhosis and frequent hepatic encephalopathy received coenzyme Q10 and Meclofenoxate in addition to usual hepatic support |
| control group | No intervention | –patients with liver cirrhosis and frequent hepatic encephalopathy received usual hepatic support only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All the patients diagnosed as having liver cirrhosis Exclusion Criteria
- recent alcohol intake;
- Infection, recent antibiotic use or gastrointestinal bleeding;
- use of drugs affecting psychometric Performances like benzodiazepines, antiepileptics, psychotropic drugs
- History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Coenzyme Q10Also: coQ10Coenzyme Q10 will be given twice | Drug | case group |
| MECLOFENOXATEAlso: LUCIDRELMECLOFENOXATE will be given as 500 mg once daily. | Drug | case group |
Primary outcome
hepatic encephalopathy
Time frame: 6 months
Change in the number of episodes
health related quality of life
Time frame: 6 months
health related quality of life questionnaire
hepatic detoxifying function
Time frame: 6 months
reduction of serum ammonia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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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.
Amr S Hanafy, M.D principal investigator
Assistant prof of medicine-Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 and MECLOFENOXATE in people with Hepatic Encephalopathy and Coenzyme Q10, run by Zagazig University at 1 site in Egypt.
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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr S Hanafy, M.D. (+201100061861, DR_AMR_HANAFY@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hepatic encephalopathy (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2019.