Chronic Viral Hepatitis B With Delta-AgentNCT06068140
Evaluation of the Effectiveness of the Complex of Carnitine Orotate and Biphenyl Dimethyl Dicarboxylate in the Adjuvant Therapy of Chronic Hepatitis D in Real Clinical Practice: a Prospective Cohort Study
An observational study of Chronic Viral Hepatitis B With Delta-Agent, run by Kazakh Association of Internal Medicine Specialists at 7 sites in Kazakhstan.
Trial summary
The goal of this observational study is to evaluate the effectiveness of the carnitine-orotate complex and biphenyl dimethyl dicarboxylate in the adjuvant therapy of chronic hepatitis D in real clinical practice: a prospective cohort study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Viral Hepatitis B With Delta-Agent
- How many people
- 0 participants
- Where
- 7 sitesKazakhstan
- Study dates
- Dec 2023to Jun 2025
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Persons aged ≥18 to 75 years inclusive with a diagnosis of chronic hepatitis D who are undergoing outpatient monitoring at the place of residence.
Who may be able to join
- Patients of both sexes aged 18 to 75 years who are citizens of the Republic of Kazakhstan;
- An established diagnosis of CGD (chronic viral hepatitis B with the delta agent);
- Patients who have contraindications to taking peg-INF-alpha2a and/or have failed treatment with peg-INF-alpha2a;
- Compensated liver disease ≤ CPT A (6 points);
- Patients without severe concomitant diseases;
- Patients who do not receive other adjuvant therapy (metabolic therapy drugs, essential phospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others);
- Patients who voluntarily signed the informed consent form.
Who cannot join
- Patients taking COC for more than 4 weeks before inclusion in the study;
- Patients with contraindications to the COC;
- Decompensated liver disease severity class > CPT A6;
- Patients taking peg-IFN-alpha 2a;
- Alcohol abuse according to the AUDIT-c questionnaire;
- Pregnancy and lactation;
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- Patients with coinfection with HIV, HCV;
- GFR ≤ 15 ml/min/1.73 m2;
- Exclude patients with significant biochemical activity (ALT, AST more than 10 ULN) and total bilirubin more than 2 norms;
- Patients with other causes of liver damage;
- Drug addict people;
- Malignant formations of the liver and other organs (in history and currently) or a clinically significant increase in alpha-fetoprotein more than 5 times or more;
- Patient takes part in an interventional clinical trial.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Kazakhstan7 sites
LLP "InkarMed"
Aktobe
Hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
Almaty
Medical Center "iClinic"
Astana
State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
Esik, Almaty Region
Karasai interdistrict multidisciplinary hospital
Kaskelen, Almaty Region
State-owned public enterprise with the right of economic management Regional infectious hospital of the state institution "Healthcare Department of the Almaty region"
Taldykorgan, Zhetisu Region
State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region
Turkestan
About this study
The goal of this observational study is to evaluate the effectiveness of the carnitine-orotate complex and biphenyl dimethyl dicarboxylate in the adjuvant therapy of chronic hepatitis D in real clinical practice: a prospective cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Patients taking Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate | |
| Control cohort | Patients who do not take Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Normalization of ALT levels during adjuvant CGD therapy at 12 months among study participants taking and not taking COC and BDD
Measured: at 12 months
Secondary outcomes (7)
Normalization of ALT levels during adjuvant CGD therapy at 6 months among study participants taking and not taking COCs AND BDD
Measured: at 6 months
Dynamics of the level of fibrosis during adjuvant CGD therapy at 6 and 12 months among study participants taking and not taking COCs AND BDD
Measured: at 6 and 12 months
Viral load during adjuvant CGD therapy at 6 and 12 months among study participants taking and not taking COC and BDD
Measured: at 6 and 12 months
Adherence to COC and BDD therapy against the background of adjuvant CGD therapy among study participants taking and not taking COCs and BDD
Measured: up to 12 months since enrollment
Dynamics of changes in the total score of the quality of life questionnaire
Measured: up to 12 months since enrollment
Incidence of adverse and serious unexpected adverse reactions associated with the use of COC and BDD
Measured: up to 12 months since enrollment
Satisfaction of patients with CGD with combination therapy of COCs and BDD
Measured: up to 12 months since enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: Administartive issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Viral Hepatitis B With Delta-AgentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakh Association of Internal Medicine Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068140
- Sponsor's protocol ID
- KAIMS-02
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Complex of Carnitine Orotate and Biphenyl Dimethyl Dicarboxylate in the Adjuvant Therapy of Chronic Hepatitis D in Real Clinical Practice: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06068140
- Acronym / sponsor ID
- KAIMS-02
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Administartive issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kazakh Association of Internal Medicine SpecialistsUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 Oct 2023 (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.
The goal of this observational study is to evaluate the effectiveness of the carnitine-orotate complex and biphenyl dimethyl dicarboxylate in the adjuvant therapy of chronic hepatitis D in real clinical practice: a prospective cohort study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | –Patients taking Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate |
| Control cohort | – | –Patients who do not take Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Persons aged ≥18 to 75 years inclusive with a diagnosis of chronic hepatitis D who are undergoing outpatient monitoring at the place of residence.
Key inclusion criteria (7 listed)
- Patients of both sexes aged 18 to 75 years who are citizens of the Republic of Kazakhstan;
- An established diagnosis of CGD (chronic viral hepatitis B with the delta agent);
- Patients who have contraindications to taking peg-INF-alpha2a and/or have failed treatment with peg-INF-alpha2a;
- Compensated liver disease ≤ CPT A (6 points);
- Patients without severe concomitant diseases;
Key exclusion criteria (13 listed)
- Patients taking COC for more than 4 weeks before inclusion in the study;
- Patients with contraindications to the COC;
- Decompensated liver disease severity class > CPT A6;
- Patients taking peg-IFN-alpha 2a;
- Alcohol abuse according to the AUDIT-c questionnaire;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Normalization of ALT levels during adjuvant CGD therapy at 12 months among study participants taking and not taking COC and BDD
Time frame: at 12 months
7 secondary outcomes
Normalization of ALT levels during adjuvant CGD therapy at 6 months among study participants taking and not taking COCs AND BDD
Time frame: at 6 months
Dynamics of the level of fibrosis during adjuvant CGD therapy at 6 and 12 months among study participants taking and not taking COCs AND BDD
Time frame: at 6 and 12 months
Viral load during adjuvant CGD therapy at 6 and 12 months among study participants taking and not taking COC and BDD
Time frame: at 6 and 12 months
Adherence to COC and BDD therapy against the background of adjuvant CGD therapy among study participants taking and not taking COCs and BDD
Time frame: up to 12 months since enrollment
Dynamics of changes in the total score of the quality of life questionnaire
Time frame: up to 12 months since enrollment
Incidence of adverse and serious unexpected adverse reactions associated with the use of COC and BDD
Time frame: up to 12 months since enrollment
Satisfaction of patients with CGD with combination therapy of COCs and BDD
Time frame: up to 12 months since enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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Hepatitis Delta With Hepatitis B Carrier State, Chronic Hepatitis b
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National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Hepatitis D, Chronic, Hepatitis B, Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Viral Hepatitis B With Delta-Agent, run by Kazakh Association of Internal Medicine Specialists at 7 sites in Kazakhstan.
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 7 inclusion and 13 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: withdrawn, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Kazakhstan. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Normalization of ALT levels during adjuvant CGD therapy at 12 months among study participants taking and not taking COC and BDD (time frame: at 12 months). 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 11 Jul 2024.