Chronic Hepatitis BEarly Phase 1NCT05523648
Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
A Early Phase 1 study testing Chronic Hepatitis B in people with Chronic Hepatitis B and Nonalcoholic Fatty Liver Disease, run by Sichuan Leshan Traditional Chinese Medicine Hospital at 1 site in China.
Trial summary
The changes in liver function, body mass index, controlled attenuation parameters, liver stiffness and HBV-DNA at different time points in each group before and after treatment were counted to explore the clinical efficacy of Ganshuang granules combined with tenofovir in the treatment of CHB complicated with NAFLD. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease
- What is being tested?
- Chronic Hepatitis B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2020to 21 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic hepatitis B patients not treated with antiviral drugs； Fatty liver was diagnosed by B-ultrasound and imaging； No history of excessive drinking； Good drug compliance and regular medication； Exclusion Criteria： Non chronic hepatitis B patients； Taking other drugs； liver failure, liver cancer and other diseases； patients who refused to sign informed consent；
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The changes in liver function, body mass index, controlled attenuation parameters, liver stiffness and HBV-DNA at different time points in each group before and after treatment were counted to explore the clinical efficacy of Ganshuang granules combined with tenofovir in the treatment of CHB complicated with NAFLD.
Read the detailed description
92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. Both groups of patients received conventional basic treatment such as liver protection. Moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise.
The control group was treated with silymarin glucosamine tablets (Jiangsu Zhongxing Pharmaceutical Co., Ltd.; National medicine permission number: H32026233; Production batch: 200304) and tenofovir (QILU Pharmaceutical Co., Ltd.; National medicine permission number: H20173185; Production batch: 1L0694DF6). The use of silymarin glucosamine tablets was 0.2g/d, 3 times/d for 24 weeks; the use of tenofovir was 300mg/d, 1 time/d for 24 weeks.
The treatment group was treated with Ganshuang granules (Baoding Tianhao Pharmaceutical Co., Ltd.; National medicine permission number: Z20027671; Production batch: 200326 ) combined with silibinin meglumine tablets and tenofovir. Libribin meglumine tablets and tenofovir were used in the same way as in the control group, and Ganshuang granules were used 3 g/time, 3 times/d, and the course of treatment was 24 weeks.
- Being tested
- Chronic Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Hepatitis BDrug
Also called Nonalcoholic Fatty Liver Disease
92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. Both groups of patients received conventional basic treatment such as liver protection. Moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| The control group | Experimental | The control group was treated with silibinin meglumine tablets and tenofovir Receives: Drug: Chronic Hepatitis B |
| The treatment group | Active comparator | The treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir Receives: Drug: Chronic Hepatitis B |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALT, AST and GGT
Alt, AST and GGT were used to evaluate the improvement of liver function before and after treatment
Measured: 12 and 24 weeks
HBV-DNA serum load < 500 IU/ml
To verify the effect of the drug on the clearance of hepatitis B virus, the number of patients with HBV-DNA serum load < 500 IU/ml before and after treatment was counted in this study
Measured: 12 and 24 weeks
liver stiffness
In our study, liver sclerosis index was detected using LSM to compare the improvement of liver stiffness before and after treatment in the two groups
Measured: 12 and 24 weeks
fat attenuation
The LSM was used to detect and compare fat attenuation parameters in this study
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start5 Jan 2020
- Primary completion20 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Leshan Traditional Chinese Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Yang, Sichuan Leshan Traditional Chinese Medicine Hospital
- Investigators
- Qin Yang, MM, Study chair, Sichuan Leshan Traditional Chinese Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523648
- Sponsor's protocol ID
- Qin1651
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Su C, Yang Q. Clinical study of ganshuang granule combined with tenofovir in the treatment of chronic hepatitis B complicated with nonalcoholic fatty liver disease. Front Pharmacol. 2022 Dec 14;13:1032789. doi: 10.3389/fphar.2022.1032789. eCollection 2022.
PubMed 36588741
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
- ClinicalTrials.gov ID
- NCT05523648
- Acronym / sponsor ID
- Qin1651
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Sichuan Leshan Traditional Chinese Medicine HospitalUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 31 Aug 2022 (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.
The changes in liver function, body mass index, controlled attenuation parameters, liver stiffness and HBV-DNA at different time points in each group before and after treatment were counted to explore the clinical efficacy of Ganshuang granules combined with tenofovir in the treatment of CHB complicated with NAFLD.
Detailed description
92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. Both groups of patients received conventional basic treatment such as liver protection. Moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise.
The control group was treated with silymarin glucosamine tablets (Jiangsu Zhongxing Pharmaceutical Co., Ltd.; National medicine permission number: H32026233; Production batch: 200304) and tenofovir (QILU Pharmaceutical Co., Ltd.; National medicine permission number: H20173185; Production batch: 1L0694DF6). The use of silymarin glucosamine tablets was 0.2g/d, 3 times/d for 24 weeks; the use of tenofovir was 300mg/d, 1 time/d for 24 weeks.
The treatment group was treated with Ganshuang granules (Baoding Tianhao Pharmaceutical Co., Ltd.; National medicine permission number: Z20027671; Production batch: 200326 ) combined with silibinin meglumine tablets and tenofovir. Libribin meglumine tablets and tenofovir were used in the same way as in the control group, and Ganshuang granules were used 3 g/time, 3 times/d, and the course of treatment was 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Experimental | Drug: Chronic Hepatitis BThe control group was treated with silibinin meglumine tablets and tenofovir |
| The treatment group | Active comparator | Drug: Chronic Hepatitis BThe treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Chronic hepatitis B patients not treated with antiviral drugs； Fatty liver was diagnosed by B-ultrasound and imaging； No history of excessive drinking； Good drug compliance and regular medication； Exclusion Criteria： Non chronic hepatitis B patients； Taking other drugs； liver failure, liver cancer and other diseases； patients who refused to sign informed consent；
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Hepatitis BAlso: Nonalcoholic Fatty Liver Disease92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. Both groups of patients received conventional basic treatment such as liver protection. Moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise. | Drug | The control group, The treatment group |
Primary outcome
ALT, AST and GGT
Time frame: 12 and 24 weeks
Alt, AST and GGT were used to evaluate the improvement of liver function before and after treatment
HBV-DNA serum load < 500 IU/ml
Time frame: 12 and 24 weeks
To verify the effect of the drug on the clearance of hepatitis B virus, the number of patients with HBV-DNA serum load < 500 IU/ml before and after treatment was counted in this study
liver stiffness
Time frame: 12 and 24 weeks
In our study, liver sclerosis index was detected using LSM to compare the improvement of liver stiffness before and after treatment in the two groups
fat attenuation
Time frame: 12 and 24 weeks
The LSM was used to detect and compare fat attenuation parameters in this study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 36588741Su C, Yang Q. Clinical study of ganshuang granule combined with tenofovir in the treatment of chronic hepatitis B complicated with nonalcoholic fatty liver disease. Front Pharmacol. 2022 Dec 14;13:1032789. doi: 10.3389/fphar.2022.1032789. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Qin Yang, MM study chair
Sichuan Leshan Traditional Chinese Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chronic Hepatitis B in people with Chronic Hepatitis B and Nonalcoholic Fatty Liver Disease, run by Sichuan Leshan Traditional Chinese Medicine Hospital 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 0 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: finished, as of the sponsor's last update on 31 Aug 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ALT, AST and GGT (time frame: 12 and 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523648, which also lists 1 linked publication.
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 31 Aug 2022.