Status:
UNKNOWN
A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Fatty Liver
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief Summary
This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. T...
Eligibility Criteria
Inclusion
- Inclusion criteria
- For inclusion in the study patients should fulfil the following criteria:
- Provision of informed consent prior to the time of registration.
- Aged 20-74 years male or female who are diagnosed with NAFLD and FibroScan shows CAP score ≥ 252 dB/m (≥Steatosis grade 2).
- 30 or more mL/min/1.73 m2 of estimated glomerular filtration rate 4.Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study (from the time they sign consent) and for 1 month after the last dose of IP to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
- Subjects who are blood donors should not donate blood during the study and for 1 month following their last dose of IP.
- Exclusion criteria
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Viral hepatitis or other types of liver disorder (e.g. drug-induced or autoimmune hepatitis).
- Alcohol consumption above recommended limits (male: more than 30g/ day; female: more than 20g/day converting to ethanol).
- Serious liver dysfunction (Child-Pugh B or C).
- History of any other malignancy within 1 years (with the exception of successfully treated non-melanoma skin cancers).
- Patients with a known hypersensitivity to investigator product (IP).
- Participation in another clinical trial within the previous 30 days or involvement in the planning and/or conduct of the study.
- Previous enrolment or randomisation in the present study.
- Active gallbladder diseases
- For women is currently pregnant (confirmed with positive pregnancy test) or breast feeding.
Exclusion
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05308160
Start Date
June 28 2021
End Date
April 30 2024
Last Update
April 1 2022
Active Locations (1)
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1
NTUH
Taipei, Zhongzheng Dist., Taiwan, 100229