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| Name | Class |
|---|---|
| R&G Pharma Studies Co.,Ltd. | INDUSTRY |
| The Affiliated Hospital of Hangzhou Normal University | OTHER |
VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to evaluate the efficacy and safety of treatment with vitamin E softgel in non diabetic adults with NASH compared to treatment with placebo in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Vitamin E softgel,100mg,Tid,orally, 96 weeks. All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise). |
|
| placebo group | Placebo Comparator | A similar appearing placebo softgel , Vitamin E -Placebo, Tid, orally, 96 weeks, All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin E softgel | Drug | All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in hepatic histology | Improvement in hepatic histology after 96 weeks of treatment as determined by liver biopsies compared to baseline. (Independent pathological evaluation committee was charged with interpreting of the histological characteristic and that allows for assessment of changes with therapy). The definition of histologic improvement requires all three of the following criteria: ① either improvement in NAS by at least 2 points or post-treatment NAS of 3 points or less, ② at least 1 point improvement in the score for ballooning or lobular inflammation③ no worsening of fibrosis stages. | after 96 weeks of treatment |
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Inclusion Criteria:
Age: 18 -75, no limitation for ethnic and gender
Body Mass Index(BMI) < 35 kg/m2
Patients with nonalcoholic steatohepatitis (NASH) based on liver biopsy obtained within 6 months before randomization. The histological evidence of NASH was defined as Non - alcoholic fatty liver disease activity score(NAS)≥ 4 (according to Nonalcoholic Steatohepatitis Clinical Research Network, NASH CRN) with a minimum 1 score for steatosis, lobular inflammation, and hepatocyte ballooning respectively.
Fibrosis stage 0-3 according to nonalcoholic steatohepatitis clinical research network(NASH CRN).
Without history of significant alcohol consumption for a period of more than 3 months within 5 years (<10 g/day for female and < 20 g/day for male).
The lab test results should meet the requirements:
① Alanine aminotransferase (ALT) < 5 times of normal upper limit
② Creatinine (Cr)< normal upper limit
③ Albumin (ALB)> 3.5g/L
④ International normalized ratio(INR)= 0.8-1.3
⑤ Fasting plasma glucose(FPG) < 126mg/dL(7mmol/L) and/or 2h postprandial plasma glucose (PPG) < 200mg/dL(11.1mmol/L)and/ or HbA1C < 6.5 %
If a participant with hypertension, he/she was required a stable antihypertensive drug(s) to keep blood pressure stable.(blood pressure < 140/90 mmHg) 3 months prior to randomization.
If a participant using a statin or fibrate, he/she was required on a stable dose to keep lipid stable (triglyceride(TG) < 1.7 mmol/L, total cholesterol (TC) < 5.72 mmol/L, LDL-c < 3.64 mmol/L) 3 months prior to randomization.
Women of childbearing potential: negative pregnancy test during screening or at randomization or willingness to use an effective form of birth control during the trial(at least include one barrier contraceptive method) and not breast feeding
Men must agree to use an effective form of birth control during the trial(at least include one barrier contraceptive method)
All participants are needed to sign the informed consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junping Shi, Phd | The Affiliated Hospital of Hangzhou Normal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Beijin | Beijing Municipality | China | |||
| 302 Military Hospital of China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39970876 | Derived | Song Y, Ni W, Zheng M, Sheng H, Wang J, Xie S, Yang Y, Chi X, Chen J, He F, Fan X, Mi Y, Zhang J, Wang B, Bai L, Xie W, Zhong B, Yeo YH, Rui F, Zang S, Li J, Shi J; Chinese NAFLD Clinical Research Network (CNAFLD CRN). Vitamin E (300 mg) in the treatment of MASH: A multi-center, randomized, double-blind, placebo-controlled study. Cell Rep Med. 2025 Feb 18;6(2):101939. doi: 10.1016/j.xcrm.2025.101939. | |
| 29411270 |
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| Placebo | Drug | All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise). Height and weight, waist-to-hip ratio Review of diet and exercise |
|
| Beijing |
| China |
| Beijing YouAn Hospital Capital Medical Univercity | Beijing | China |
| West China Hospital, Sichuan university | Chengdu | China |
| The first Affiliated Hospital, Sun Yat-sen University | Guangdong | China |
| Guangdong Provincial Chinese Medicine Hospital | Guangzhou | China |
| Nanfang Hospital | Guangzhou | China |
| The Affiliated Hospital of Hangzhou Normal University | Hangzhou | China |
| Southwest Medical University Affiliated | Luzhou | China |
| The Second Hospital of Nanjing | Nanjing | China |
| The First Hospital of China Medical University | Shenyang | China |
| The second people's Hospital of Tianjin | Tianjin | China |
| The First Affiliated Hospital of Medical University | Ürümqi | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhu | China |
| General Hospital Ningxia Medical | Yinchuan | China |
| Derived |
| Zang S, Chen J, Song Y, Bai L, Chen J, Chi X, He F, Sheng H, Wang J, Xie S, Xie W, Yang Y, Zhang J, Zheng M, Zou Z, Wang B, Shi J; Chinese NAFLD Clinical Research Network (CNAFLD CRN). Haptoglobin Genotype and Vitamin E Versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis in China: A Multicenter, Randomized, Placebo-Controlled Trial Design. Adv Ther. 2018 Feb;35(2):218-231. doi: 10.1007/s12325-018-0670-8. Epub 2018 Feb 6. |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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