Actively Recruiting
HuHuangLianzonggan Capsule in Subjects With Nonalcoholic Steatohepatitis: a Phase 2 tRial(HHL-HEPAR)
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2024-08-29
76
Participants Needed
20
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.
CONDITIONS
Official Title
HuHuangLianzonggan Capsule in Subjects With Nonalcoholic Steatohepatitis: a Phase 2 tRial(HHL-HEPAR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 75 years inclusive.
- Liver biopsy proven NASH within 6 months or at screening with a non-alcoholic fatty liver disease activity score (NAS) of 4 or higher, including at least 1 point in steatosis, lobular inflammation, and ballooning degeneration.
- Fibrosis stage between 1 and 3.
- Confirmation of 8% or higher liver fat content on MRI-PDFF at screening.
- No alcohol consumption exceeding 210 g per week for men or 140 g per week for women in the past 12 months.
- Stable dose of any chronic drugs for at least 3 months before liver biopsy.
- Weight stable within 5% during the 6 months before screening.
- No lifestyle changes (diet or exercise) during the 3 months before screening.
- Ability to understand study requirements and provide written informed consent.
- No pregnancy plans and voluntary use of effective contraception.
- Willingness to follow the study protocol and cooperate with data collection as judged by the researcher.
You will not qualify if you...
- Use of drugs causing NAFLD within 12 months before qualifying liver biopsy (e.g., valproic acid, tamoxifen, methotrexate, amiodarone, oral corticosteroids over 5 mg/day prednisone equivalent, or high-dose estrogens).
- Other causes of fatty liver disease besides NASH, including certain infections, autoimmune diseases, genetic conditions, and drug-induced liver disease.
- MELD score over 12.
- Liver cirrhosis (fibrosis stage F4) or current/history of hepatocellular carcinoma.
- History of or planned liver transplant.
- Positive tests for hepatitis A, B, C, D, or E.
- Abnormal liver function tests beyond specified limits.
- Impaired blood coagulation in patients not on anticoagulants.
- Severe kidney impairment (eGFR below 30 mL/min/1.73 m2).
- Currently receiving any approved treatment for NASH.
- HbA1c 9% or higher or fasting blood glucose above 13.9 mmol/L.
- Diabetes other than type 2.
- BMI below 23 kg/m2 or 40 kg/m2 and above.
- Bariatric or tumor surgery within 5 years before liver biopsy.
- Uncontrolled high or low blood pressure.
- Recent acute vascular events or surgeries within 6 months.
- Mental illness impairing consent or adverse event reporting.
- No liver biopsy within 6 months before screening and refusal to biopsy at screening.
- Allergic to the study drug or its ingredients.
- Pregnant or breastfeeding women.
- Participation in other drug trials within 3 months before screening.
- Investigator judgment deeming participation inappropriate.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Not Yet Recruiting
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
The first affiliated hospital of Fujian medical university
Fuzhou, Fujian, China
Not Yet Recruiting
5
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
6
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Actively Recruiting
7
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Actively Recruiting
8
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
9
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Actively Recruiting
10
The Affiliated Hospital of Nanjing University medical school，Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
11
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Actively Recruiting
12
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
13
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Not Yet Recruiting
14
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Actively Recruiting
15
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
16
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
Actively Recruiting
17
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang, China
Actively Recruiting
18
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Actively Recruiting
19
Taizhou Municipal Hospital
Taizhou, Zhejiang, China
Actively Recruiting
20
Rui'an People's Hospital
Wenzhou, Zhejiang, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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