New pill could help hepatitis b patients who Don't respond to standard care
NCT ID NCT07090759
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether adding GST-HG141 (Neracorvir) to standard antiviral therapy can better suppress the hepatitis B virus in patients who haven't responded adequately to current drugs. About 526 adults with chronic hepatitis B will receive either the experimental drug or a placebo, alongside their usual medication. The main goal is to see if the virus levels become undetectable during treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GST-HG141 (Neracorvir) – an experimental drug taken as a pill
- What this could lead to
- If successful, this could offer a new combination treatment option for people with chronic hepatitis B who don't respond well enough to current antiviral drugs.
- What could go wrong
- This is a Phase 3 trial, but it's still experimental. The drug may not work better than placebo, and side effects are possible. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 526 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2025
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female individuals aged 18-70 years (inclusive of the boundaries); 2. 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); 3. 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 past year), and are receiving treatment at the time of screening and agree to accept the treatment plan provided by this study during the study period; \* Have maintained the same NA monotherapy for more than 3 months before screening 4. HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA \> 50 IU/mL; 5. At the time of screening, ALT ≤ 5×ULN; 6. 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 completion of the study ; 7. Sign the informed consent form before the trial and be able to complete the study as required by the trial protocol. Exclusion Criteria: 1. 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; 2. Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, or substrates within 28 days prior to screening; 3. 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 1 month prior to screening; 4. Presence of acute infections requiring treatment prior to randomization; 5. 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; 6. Subjects with a history of cirrhosis (e.g., subjects who have undergone pathological examination of liver tissue with a report indicating cirrhosis or those who have undergone endoscopy indicating esophageal or gastric varices); or subjects with currently diagnosed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal or gastric varices, splenomegaly, and ascites; or subjects with significant progression of liver fibrosis; 7. 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 malignancies within the past 5 years (except for cured basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ); 8. 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 or atrophic gastritis), partial gastrectomy, Grade \> 2 gastrointestinal symptoms at screening (e.g., nausea, vomiting, or diarrhea), etc.; 9. 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 determined by the investigator. 10. Subjects with major trauma or major surgery within 3 months prior to screening; or those who plan to undergo surgery during the study period; 11. Laboratory tests: 1. Platelet count \< 100 × 109/L; 2. White blood cell count \< 3.0 × 109/L; 3. Absolute neutrophil count \< 1.3 × 109/L; 4. Serum total bilirubin \> 2× ULN; 5. Albumin \< 35 g/L; 6. GFR ≤ 60 mL·min-1·(1.73 m2)-1 (calculated using the CKD-EPI formula); 7. International normalized ratio (INR) of prothrombin time \>1.5; 12. Positive for hepatitis C antibody, positive for HIV antigen/antibody, or positive for syphilis antibody with a positive RPR or TRUST test result; 13. 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); 14. History of drug dependence or substance abuse; 15. 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; 16. Women who are breastfeeding or tested positive for pregnancy; 17. Determined by the investigator to be unsuitable for this trial for any other reasons.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic hepatitis B are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Shulan(Hangzhou) Hospital
RECRUITINGHangzhou, Zhejiang, 310011, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Safety and efficacy of sequential treatment with a PD-1 antibody and pegylated interferon-α in Nucleos(t)Ide Analogue-Suppressed patients with chronic hepatitis b
- Can a new pill push hepatitis b virus to undetectable levels?
- Can a newer hepatitis b drug protect babies while being gentler on their bones?
- CRISPR 'Brake Release' may reawaken immune cells to beat hepatitis b
- Can a vaccine teach the immune system to fight hepatitis b?
- Could a simple scan and blood test outsmart liver cancer?