Individual Study / Zang et al.; Adv Ther. 2018

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

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

Initiatives -
This clinical trial of vitamin E versus placebo for the treatment of nondiabetic patients with nonalcoholic steatohepatitis (VENS) is conducted to evaluate (a) the efficacy and safety of treatment with vitamin E softgel (300 mg/day) determined from standardized histologic scoring of liver biopsies, (b) whether treatment with vitamin E improves biochemical parameters, cytokines, anthropometric parameters, controlled attenuation parameter (CAP), and transient elastography (TE) values determined by Fibroscan and health-related quality of life (SF-36), (c) whether the efficacy of vitamin E treatment is associated with the Hp genotype in nondiabetic adults with NASH. Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
Start Year
2016
Funding
Zhejiang Medicine Co

Design

Study design
Clinical trial cohort

Marker Paper

Zang S, Chen J, Song Y, et al. 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;35(2):218‐231. doi:10.1007/s12325-018-0670-8 Forma

PUBMED 29411270

Recruitment

Sources of Recruitment
  • Individuals

Number of participants

Number of participants
120
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

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.
Selection Criteria
Minimum age
19
Maximum age
75
Newborns
Twins
Countries
  • China
Territory
Beijing
Ethnic Origin
Health Status
  • 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.

Recruitment

Sources of recruitment
  • General population

Number of participants

Number of participants
120
Number of participants with biosamples
Data Collection Event
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.
Start Date
2016-12
End Date
2021-05
Data sources
  • Mobile data collection
    • Mobile phone
    • Smartphone
    • Smartphone apps