New shot combo aims to silence hepatitis b virus
NCT ID NCT07245953
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two experimental injections, HT-101 and HT-102, in 60 adults with chronic hepatitis B who are already on standard antiviral therapy. The goal is to see if the combination can lower hepatitis B virus levels to undetectable and help the immune system control the infection. The trial is double-blind and placebo-controlled, meaning some participants receive dummy shots for comparison.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HT-101 and HT-102 injections
- What this could lead to
- If successful, this combination could offer a new way to control chronic hepatitis B, potentially allowing patients to stop long-term antiviral therapy.
- What could go wrong
- This is an early Phase 2 study with only 60 participants, so results may not apply broadly. The treatment may not work as hoped, and side effects are still being evaluated.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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: * Subjects were eligible for inclusion into the study if they met each of the following criteria: Patient with CHB Male subjects weighed ≥ 45.0 kg, female subjects weighed ≥ 40.0 kg, with a body mass index (BMI) between 19.0 and 30.0 kg/m\^2 (inclusive); Chronic HBV infection for \>/= 6 months; The quantitation level of HBsAg was \> 100 IU/mL and \<3000 IU/mL; The quantitation level of HBV DNA \<LLOQ; · On Nas therapy for \>/= 6 months at the time of screening Subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial; Exclusion Criteria: * Subjects were excluded from the study if one or more of the following criteria were applicable Participants with history of drug allergy or specific allergy; Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems; Participants with history of active pathological bleeding, or bleeding tendency; Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians; Participants with significant liver fibrosis or cirrhosis; Participants with symptoms or a history of hepatic decompensation; Participants with a history or suspected risk of liver cancer;
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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.
Contacts and locations
Locations
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Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, 100015, China
-
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510440, China
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Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000, China
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Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350028, China
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Nanchang Ninth Hospital
Nanchang, Jiangxi, 330022, China
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Nanfang Hospital
Guangzhou, Guangdong, 510515, China
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Qingyuan People's Hospital
Qingyuan, Guangdong, 511518, China
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Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
Nanning, Guangxi, 530011, China
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Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200083, China
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
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The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003, China
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Zhenjiang Third People's Hospital (Zhenjiang Infectious Diseases Hospital)
Zhenjiang, Jiangsu, 212021, China
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Other studies related to the condition(s) this trial covers.
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