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Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
Plain-language guide to NCT03604016: phase 4 randomized trial of L-Carnitine, fatty liver & elevated liver enzymes, 76 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03604016
- Phase
- phase 4
- Status
- status unknown
- Start
- 2018-09-23
- Completion (planned or actual)
- 2020-07-30
- Participants
- 76 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Hepatitis B
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test L-Carnitine for fatty liver & elevated liver enzymes.
It had two arms (groups): Besifovir dipivoxil+L-carnitine (experimental) and Tenofovir Alafenamide (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 76 planned participants were the target.
It was open to people of any sex aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 20 years of age and older, Male or female patients. Chronic hepatitis B patients with Nonalcoholic fatty liver. Patients who have been explained about the trial and agreed to the consent. Patients who agree with the approved method of contraception during the clinical trial.
The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: patients with hepatitis c virus, hepatitis d virus or human immunodeficiency virus; patients who has a history of liver transplantation or child-pugh score \>=8; alpha-fetoprotein (afp) \> 50 ng/ml or hepatocellular carcinoma (hcc) patients.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The L-Carnitine group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label L-Carnitine study: the fatty liver & elevated liver enzymes participants and staff both knew the treatment.
It started in 2018-09-23 with completion listed for 2020-07-30.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of L-Carnitine in 76 people with fatty liver & elevated liver enzymes.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the L-Carnitine compound page, Fatty liver & elevated liver enzymes research.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.