HEPATITIS B CHRONICNCT07555340
A Real-World Study on the Efficacy and Safety of Pradefovir Mesylate Tablets in the Treatment of Chronic Hepatitis B
An observational study of HEPATITIS B CHRONIC, run by Juan Li at 1 site in China.
Trial summary
This study is a multicenter, ambidirectional cohort real-world study initiated by the First Affiliated Hospital of Zhengzhou University, aiming to evaluate the efficacy and safety of Pradefovir Mesylate Tablets in the treatment of chronic hepatitis B (CHB). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HEPATITIS B CHRONIC
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to Jun 2028
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: treatment-naive/treatment-experienced patients with chronic hepatitis B
Who may be able to join
- (1) Aged 18 to 65 years (inclusive), regardless of gender; (2)Meet the diagnostic criteria for chronic hepatitis B (with documented HBsAg or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy) and test positive for HBsAg, HBeAg, and anti-HBc simultaneously; (3)Fulfill the indications for antiviral therapy as per the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)": ① Serum HBV DNA positive, with persistently abnormal ALT (> ULN), and other causes ruled out; ② Serum HBV DNA positive individuals, regardless of ALT levels, are recommended for antiviral therapy if they meet any of the following criteria: I. Family history of hepatitis B-related cirrhosis or HCC; II. Age >30 years; III. Non-invasive indicators or histologic examination suggesting significant liver inflammation (G≥2) or fibrosis (F≥2); IV. HBV-related extrahepatic manifestations (e.g., HBV-associated glomerulonephritis); ③ Clinically diagnosed compensated hepatitis B cirrhosis patients. (4)No restriction on treatment-naïve or treatment-experienced patients; (5)Agreement to use effective non-pharmacological contraceptive measures during the trial; (6)Agreement to participate in this clinical trial and voluntary signing of the informed consent form.
Who cannot join
- (1) Evidence suggestive of hepatocellular carcinoma (HCC) or serum alpha-fetoprotein (AFP) >100 μg/L; (2)Presence of signs indicating significant hepatic decompensation, such as ascites, hepatic encephalopathy, or esophageal/gastric variceal bleeding; (3)Platelet count (PLT) <30×10⁹/L, or hemoglobin (Hb) <100 g/L, or albumin (ALB) <30 g/L, or total bilirubin (TBIL) >2.5×upper limit of normal (ULN); (4)Co-infection with hepatitis C or D virus, HIV, autoimmune hepatitis, or other causes of active hepatitis; (5)History of allergy to nucleos(t)ide analogues, or documented resistance to nucleos(t)ide analogues; (6)Severe cardiopulmonary dysfunction, advanced malignancy, central nervous system disorders (e.g., history of epilepsy), or other systemic diseases; (7)Neurological or psychiatric disorders that preclude cooperation or willingness to cooperate; (8)Pregnancy, lactation, or planning pregnancy in the near future; (9)Inability or unlikelihood to complete the 2-year follow-up after enrollment; (10)Use of strong or moderate CYP3A4 or P-gp inhibitors (e.g., ketoconazole, erythromycin, itraconazole) or strong CYP3A4 or P-gp inducers (e.g., rifampicin, phenytoin sodium) within the past 3 months or currently taking such medications; (11)Other reasons deemed by the investigator as unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
Official title: A Real-World Study on the Efficacy and Safety of Pradefovir Mesylate Tablets in the Treatment of Chronic Hepatitis B: A Multicenter, Ambispective Cohort Study
This study is a multicenter, ambidirectional cohort real-world study initiated by the First Affiliated Hospital of Zhengzhou University, aiming to evaluate the efficacy and safety of Pradefovir Mesylate Tablets in the treatment of chronic hepatitis B (CHB).
- Conditions
- HEPATITIS B CHRONIC
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Pradefovir Mesylate Tablet was administered orally at a dose of 45 mg once daily. | |
| Control Group | Orally administered other NAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatitis B virus DNA levels
virological response (VR): Undetectable hepatitis B virus DNA levels,
Measured: From enrollment to the end of treatment at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start30 Dec 2024
- Primary completionMay 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS B CHRONICStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- Juan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Li, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555340
- Sponsor's protocol ID
- JHSPLFW2506
- Status last verified
- Oct 2025
- First submitted
- 21 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study on the Efficacy and Safety of Pradefovir Mesylate Tablets in the Treatment of Chronic Hepatitis B: A Multicenter, Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT07555340
- Acronym / sponsor ID
- JHSPLFW2506
- Conditions
- HEPATITIS B CHRONIC
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Juan LiUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, ambidirectional cohort real-world study initiated by the First Affiliated Hospital of Zhengzhou University, aiming to evaluate the efficacy and safety of Pradefovir Mesylate Tablets in the treatment of chronic hepatitis B (CHB).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 48 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –Pradefovir Mesylate Tablet was administered orally at a dose of 45 mg once daily. |
| Control Group | – | –Orally administered other NAs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- treatment-naive/treatment-experienced patients with chronic hepatitis B
Key inclusion criteria (1 listed)
- (1) Aged 18 to 65 years (inclusive), regardless of gender; (2)Meet the diagnostic criteria for chronic hepatitis B (with documented HBsAg or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy) and test positive for HBsAg, HBeAg, and anti-HBc simultaneously; (3)Fulfill the indications for antiviral therapy as per the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)": ① Serum HBV DNA positive, with persistently abnormal ALT (> ULN), and other causes ruled out; ② Serum HBV DNA positive individuals, regardless of ALT levels, are recommended for antiviral therapy if they meet any of the following criteria: I. Family history of hepatitis B-related cirrhosis or HCC; II. Age >30 years; III. Non-invasive indicators or histologic examination suggesting significant liver inflammation (G≥2) or fibrosis (F≥2); IV. HBV-related extrahepatic manifestations (e.g., HBV-associated glomerulonephritis); ③ Clinically diagnosed compensated hepatitis B cirrhosis patients. (4)No restriction on treatment-naïve or treatment-experienced patients; (5)Agreement to use effective non-pharmacological contraceptive measures during the trial; (6)Agreement to participate in this clinical trial and voluntary signing of the informed consent form.
Key exclusion criteria (1 listed)
- (1) Evidence suggestive of hepatocellular carcinoma (HCC) or serum alpha-fetoprotein (AFP) >100 μg/L; (2)Presence of signs indicating significant hepatic decompensation, such as ascites, hepatic encephalopathy, or esophageal/gastric variceal bleeding; (3)Platelet count (PLT) <30×10⁹/L, or hemoglobin (Hb) <100 g/L, or albumin (ALB) <30 g/L, or total bilirubin (TBIL) >2.5×upper limit of normal (ULN); (4)Co-infection with hepatitis C or D virus, HIV, autoimmune hepatitis, or other causes of active hepatitis; (5)History of allergy to nucleos(t)ide analogues, or documented resistance to nucleos(t)ide analogues; (6)Severe cardiopulmonary dysfunction, advanced malignancy, central nervous system disorders (e.g., history of epilepsy), or other systemic diseases; (7)Neurological or psychiatric disorders that preclude cooperation or willingness to cooperate; (8)Pregnancy, lactation, or planning pregnancy in the near future; (9)Inability or unlikelihood to complete the 2-year follow-up after enrollment; (10)Use of strong or moderate CYP3A4 or P-gp inhibitors (e.g., ketoconazole, erythromycin, itraconazole) or strong CYP3A4 or P-gp inducers (e.g., rifampicin, phenytoin sodium) within the past 3 months or currently taking such medications; (11)Other reasons deemed by the investigator as unsuitable for participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hepatitis B virus DNA levels
Time frame: From enrollment to the end of treatment at 48 weeks
virological response (VR): Undetectable hepatitis B virus DNA levels,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HEPATITIS B CHRONIC, run by Juan Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hepatitis B virus DNA levels (time frame: From enrollment to the end of treatment at 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.