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Tests treatment safety and results for Chronic Hepatitis b
Official title To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment
ClinicalTrials.gov ID: NCT07090759
What this study is testing
What is GST-HG141?
GST-HG141 is an investigational medicine, being studied as a potential treatment for chronic hepatitis b.
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 is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GST-HG141 in patients with chronic hepatitis B who have an inadequate response to antiviral drug treatment.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 70
You may be able to join if
- Male or female individuals aged 18-70 years (inclusive of the boundaries);
- Male weight ≥ 50 kg, female weight ≥ 45 kg, with a body mass index (BMI) within the range of 18-35 kg/m2 (inclusive of the boundaries);
- Have been continuously taking nucleoside analogues (entecavir [ETV], tenofovir disoproxil fumarate [TDF], emivirofavir [TMF], or propivirofavir...
- HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA \> 50 IU/mL;
- At the time of screening, ALT ≤ 5×ULN;
You likely can't join if
- History of life-threatening severe allergic reactions such as anaphylactic shock, or allergy to the active ingredients or excipients of the study...
- Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, or substrates within 28 days prior to screening;
- Systemic use of immunosuppressants, immunomodulators (interferon must be discontinued for more than 12 months), or cytotoxic drugs within 6 months...
- Presence of acute infections requiring treatment prior to randomization;
- Clinically significant acute or chronic liver disease not caused by HBV infection, rendering the subject unsuitable for participating in the study as...
- people with a history of cirrhosis (e.g., people who have undergone pathological examination of liver tissue with a report indicating cirrhosis or...
See the full eligibility criteria
- Male or female individuals aged 18-70 years (inclusive of the boundaries);
- Male weight ≥ 50 kg, female weight ≥ 45 kg, with a body mass index (BMI) within the range of 18-35 kg/m2 (inclusive of the boundaries);
- Have been continuously taking nucleoside analogues (entecavir [ETV], tenofovir disoproxil fumarate [TDF], emivirofavir [TMF], or propivirofavir [TAF]) for more than one year (with a break of less than one month in the...
- HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA \> 50 IU/mL;
- At the time of screening, ALT ≤ 5×ULN;
- Male participants with a fertile female partner or female participants of childbearing age who are willing to voluntarily take effective contraceptive measures from the time of screening until 28 days after the...
- Sign the informed consent form before the trial and be able to complete the study as required by the trial protocol.
- History of life-threatening severe allergic reactions such as anaphylactic shock, or allergy to the active ingredients or excipients of the study drug as suspected by the investigator;
- Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, or substrates within 28 days prior to screening;
- Systemic use of immunosuppressants, immunomodulators (interferon must be discontinued for more than 12 months), or cytotoxic drugs within 6 months prior to screening; or vaccination with live attenuated vaccines within...
- Presence of acute infections requiring treatment prior to randomization;
- Clinically significant acute or chronic liver disease not caused by HBV infection, rendering the subject unsuitable for participating in the study as determined by the investigator;
- people with a history of cirrhosis (e.g., people who have undergone pathological examination of liver tissue with a report indicating cirrhosis or those who have undergone endoscopy indicating esophageal or gastric...
- Primary liver cancer; serum alpha-fetoprotein (AFP) greater than 20 μg/L (or 20 ng/mL) or DCP\>40 mAU/mL or imaging suggesting possible malignant lesions in the liver; concurrent other malignancies or history of other...
- Presence of gastrointestinal impairment or gastrointestinal disease that may affect the absorption of oral medication in the judgment of the investigator, such as severe gastrointestinal diseases (peptic ulcer, erosive...
- Concurrent severe diseases of the circulatory, respiratory, urinary, hematologic, metabolic, immune, psychiatric, neurological, renal, or other systems, rendering the subject unsuitable for participating in the study as...
- people with major trauma or major surgery within 3 months prior to screening; or those who plan to undergo surgery during the study period;
- Laboratory tests:
- Platelet count \< 100 × 109/L;
- White blood cell count \< 3.0 × 109/L;
- Absolute neutrophil count \< 1.3 × 109/L;
- Serum total bilirubin \> 2× ULN;
- Albumin \< 35 g/L;
- GFR ≤ 60 mL min-1 (1.73 m2)-1 (calculated using the CKD-EPI formula);
- International normalized ratio (INR) of prothrombin time \>1.5;
- Positive for hepatitis C antibody, positive for HIV antigen/antibody, or positive for syphilis antibody with a positive RPR or TRUST test result;
- History of sustained alcohol abuse within the past 3 years (weekly alcohol intake \> 14 units, where 1 unit of alcohol equals 1 bottle of 350 mL beer, 120 mL wine, or 30 mL of spirits at 40% alcohol content);
- History of drug dependence or substance abuse;
- Participation in clinical trials involving other investigational drugs or medical devices and receiving the investigational drug or using the medical device within 3 months prior to screening;
- Women who are breastfeeding or tested positive for pregnancy;
- Determined by the investigator to be unsuitable for this trial for any other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. 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.