Table 3. Schedule for observations, tests and assessments.
| Perioditem | Screening period | Administration period | Follow-up period | |||||||
| −91st to date of registration | 0 weekStart date of administration | 4 weeks | 8 weeks | 12 weeks | 24 weeks | 36 weeks | 48 weeks(the time of discontinuation)*† | 6 weeks after completion of administration | ||
| Tolerance (days) | – | – | ±7 | ±7 | ±14 | ±14 | ±14 | ±14 | ±14 | |
| Visit | Visit 1 | Visit 2‡ | Visit 3 | Visit 4¶¶ | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 | |
| Obtainment of consent | 〇 | |||||||||
| Registration | 〇 | |||||||||
| Study drug administration§ |
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| Patient background check | 〇 | |||||||||
| Survey of alcohol consumption and smoking status | 〇 | |||||||||
| Weight, BMI¶, abdominal circumference | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | ||||
| Vital signs | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | |
| ECG | Ο** | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | |
| Clinical examination†† | Haematologic test | Ο** | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 |
| Blood chemistry test‡‡ | Ο** | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | |
| Measurement of liver fat content and fibrosis (MRE or USE) | Ο**§§ | Ο§§ | ||||||||
| Liver disease-related events |
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| Cardiovascular eventspresence of carcinogenesis in other organs |
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| Investigation of concomitant medications |
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| Observation of disease, etc and adverse events |
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At the time of discontinuation, only tests that can be performed will be conducted, and the data will be submitted.
In the discontinuation test, liver fat content and fibrosis measurements (MRE or USE) were not performed.
Visits 1 and 2 may occur on the same day. Blood collection at visit 2 may be substituted with that at visit 1, but missing values are compensated for separately.
The study drug should be prescribed every 4 weeks up to week 12 and every 12 weeks after week 12.
Body mass index was calculated based on height and weight.
Blood collection, ECG and imaging tests within 3 months prior to obtaining consent can be substituted for screening tests.
Fasting blood samples should be obtained (fasting for >8 hours).
Type IV collagen 7s, enhanced liver fibrosis and Mac-2 binding protein glycosylation isomer were measured only after 0 and 48 weeks.
MRE or USE should only be performed at facilities where they are available. The tolerable date range of liver fat content and fibrosis measurement (MRE or USE) after 48 weeks of administration is ±14 days.
At visit 4 (8 weeks after administration), an in-person visit is not required; however, a telephone safety confirmation should always be made.
MREMR elastographyUSEultrasound elastography