Sponsor study identifier
observational
264
1 country
7
Study Start
February 8, 2023
Actual (reported)Primary Completion
February 8, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 8, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this observational study is to learn the effectiveness and safety of the use of Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate in the pathogenetic therapy of metabolic-associated fatty liver disease (MAFLD)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 8, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2023
Actual (reported)September 25, 2023
Actual (reported)October 12, 2023
Actual (reported)February 8, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 8, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Normalization of ALT levels during pathogenetic therapy for MAFLD at 12 months among study participants taking and not taking carnitine-orotate complex(COC) and biphenyl dimethyl dicarboxylate(BDD)
at 12 months
Normalization of ALT levels during pathogenetic therapy for MAFLD at 6 months among study participants taking and not taking COC and BDD
at 6 months
Fibrosis level during pathogenetic therapy for MAFLD at 6 and 12 months among study participants taking and not taking COC and BDD
at 6 and 12 months
Steatosis level during pathogenetic therapy for MAFLD at 6 and 12 months among study participants taking and not taking COC and BDD
at 6 and 12 months
Assessment of adherence to COC and BDD therapy against the background of pathogenetic therapy for MAFLD in a cohort taking COC and BDD
up to 12 months since enrollment
Assessment of the impact of COC and BDD against the background of pathogenetic therapy for MAFLD on the quality of life of study participants taking and not taking COC and BDD
up to 12 months since enrollment
Patients taking Carnitine-Orotate Complex and BDD regardless of study participation. The duration of observation for taking COCs and BDD is 6 months, and the duration of follow-up is 6 months.
Patients who do not take Carnitine-Orotate Complex and BDD, regardless of study participation. Duration of patient observation - 12 months.
Persons aged ≥18 to 75 years inclusive with a diagnosis of metabolic-associated fatty liver disease who are undergoing outpatient monitoring at the place of residence.
State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
Esik, Almaty Region, Kazakhstan
LLP "InkarMed"
Aktobe, Kazakhstan
First Submitted
September 25, 2023
First Posted
October 12, 2023
Study Start
February 8, 2023
Actual (reported)Primary Completion
February 8, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
Almaty, Kazakhstan
Medical Center "iClinic"
Astana, Kazakhstan
Non-profit joint-stock company "Semey Medical University"
Semey, Kazakhstan
Medical center "Gatromed"
Shymkent, Kazakhstan
State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region
Turkestan, Kazakhstan
Study Completion
February 8, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 12, 2023
Record last verified: 2023-09
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Source: ClinicalTrials.gov.
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