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New treatment option for NASH
Official title HuHuangLianzonggan Capsule in Subjects With Nonalcoholic Steatohepatitis: a Phase 2 tRial(HHL-HEPAR)
ClinicalTrials.gov ID: NCT05632861
What this study is testing
What is HuHuangLianzonggan capsule?
HuHuangLianzonggan capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nash.
Also referred to as Experimental group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Males and females between 18-75 years of age inclusive(including boundary values).
- Must have had a liver biopsy proven NASH within 6 months or in screening test. The following two requirements must be met at the same time: ① a...
- Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
- No alcohol consumption or history of excessive alcohol consumption: less than 210 g of ethanol per week for men and 140 g for women in the past 12...
- Patients who are taking chronic drugs(including but not limited to antihypertensive drugs, antiatherogenic drugs, oral hypoglycemic drugs, insulin)...
You likely can't join if
- Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying...
- Documented causes of fatty liver disease other than NASH including, but not restricted to: HCV-associated fatty liver (genotype 3), hepatolenticular...
- Model for End-stage Liver Disease (MELD) score \>12.
- Histologically documented liver cirrhosis (fibrosis stage F4), history or current diagnosis of hepatocellular carcinoma HCC.
- History of or planned liver transplant.
- Viral hepatitis：Positive hepatitis A antibody，Positive hepatitis D antibody，Positive hepatitis E antibody，Positive hepatitis B surface antigen...
See the full eligibility criteria
- Males and females between 18-75 years of age inclusive(including boundary values).
- Must have had a liver biopsy proven NASH within 6 months or in screening test. The following two requirements must be met at the same time: ① a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with...
- Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
- No alcohol consumption or history of excessive alcohol consumption: less than 210 g of ethanol per week for men and 140 g for women in the past 12 months.
- Patients who are taking chronic drugs(including but not limited to antihypertensive drugs, antiatherogenic drugs, oral hypoglycemic drugs, insulin) need to have a steady dose for at least 3 months before liver biopsy.
- Weight was stable(the change is no more than 5%) during the 6 months prior to Screening.
- No attempt to change lifestyle (diet and/or exercise) during the 3 months prior to Screening.
- Ability to understand the requirements of the study and willingness to provide written informed consent.
- Have no pregnancy program and take effective contraceptive measures voluntarily.
- Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment.
- Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy (e.g. valproic acid, tamoxifen, methotrexate, amiodarone...
- Documented causes of fatty liver disease other than NASH including, but not restricted to: HCV-associated fatty liver (genotype 3), hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition...
- Model for End-stage Liver Disease (MELD) score \>12.
- Histologically documented liver cirrhosis (fibrosis stage F4), history or current diagnosis of hepatocellular carcinoma HCC.
- History of or planned liver transplant.
- Viral hepatitis：Positive hepatitis A antibody，Positive hepatitis D antibody，Positive hepatitis E antibody，Positive hepatitis B surface antigen (HBsAg) ，Positive hepatitis C antibody.
- Abnormal liver function as defined by Screening central laboratory evaluation of any of the following: ALT or AST \>5 × ULN; Alkaline phosphatase (ALP) \>2 × ULN; albumin below the lower limit of the normal range; total...
- In patients who are not anticoagulated, INR ≥ 1.3 times ULN or other evidence of impaired coagulation.
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value \<30 mL/min/1.73 m2.
- Patient currently receiving any approved treatment for NASH.
- HbA1c ≥9% or fasting blood-glucose\>13.9 mmol/L at Screening.
- Diabetes mellitus other than type 2 (e.g. type 1, diabetes caused by drugs or chemicals, and immune-mediated diabetes).
- Those who are underweight, of normal weight, or severely obese, i.e BMI\<23 kg/m2 or BMI≥40 kg/m2.
- Bariatric surgery or tumor surgery are not allowed within 5 years of the qualifying liver biopsy.
- Uncontrolled hypertension (values ≥160/100 mm Hg) or hypotension（values \<80/50 mmHg）.
- Acute vascular events including ACS, stroke, peripheral vascular disease worsened, or any vascular/cardiac surgery within the 6 months prior to Screening.
- Concomitant mental illness and poor condition control, which affects the signing of informed consent or presentation of adverse events.
- Do not have a liver biopsy within the 6 months prior to Screening and refuse to take liver biopsy at Screening.
- Allergic constitution, or allergic to the test drug or its ingredients.
- Women who are pregnant or lactating.
- Participate in clinical trials of other drugs within 3 months before screening.
- The researchers did not consider it appropriate to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Luoyang, Henan, China
- Wuhan, Hubei, China
- Lianyungang, Jiangsu, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Yinchuan, Ningxia, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Taizhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Luoyang, Henan, China and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.