Hepatitis B, ChronicPhase 2HBVNCT02499562
A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
A Phase 2 study testing Hydronidone and Entecavir in people with Hepatitis B, Chronic, run by Shanghai Genomics, Inc. at 2 sites in China.
Trial summary
To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Hydronidone and Entecavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jun 2015to 20 Nov 2020
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65, all genders.
- History of chronic hepatitis B, HBsAg positive≧six months.
- ALT<eight-fold ULN (maximum).
- Significant liver fibrosis confirmed by liver biopsy.
- HBeAg positive patients, HBV DNA>2.0×104 IU/mL (copies/mL); HBeAg negative patients，HBV DNA>2.0×103 IU/mL (104copies/mL).
- Having not accepted the antiviral therapy with interferon and/or nucleoside analog.
- Having not taken anti-inflammatory drugs to protect liver within 1 month before selection.
- Capable of understanding and signing the informed consent before the study.
Who cannot join
- Failing to meet any one requirement of the inclusion criteria.
- Having suffered massive hemorrhage of gastrointestinal tract within 3 months before selection
- TBiL>three-fold ULN.
- AFP>100 ug/L
- PLT≦60×109/L
- PTA<50%
Show all 18Show fewer
- Having obvious space-occupying lesion in liver as shown by B ultrasound examination.
- With a portal vein ≧1.2cm wide as shown by B ultrasound examination.
- BMI index>30.
- The patient who suffered from liver function decompensation hepatic cirrhosis and liver neoplasms.
- The patient with alcoholic, drug-induced, hereditary, immune and other viral and non- viral chronic hepatitis.
- The patient with angiocarpy, lung, kidney, incretion, nerve and blood system disease and mental disease.
- The patient with active peptic ulcer.
- Gestational and breast feeding women.
- The subject is the legal disabled person according to the Law of the People's Republic of China on the Protection of Disabled Persons of the April 2008 edition.
- The subject who participated in other drug tests within recent 3 months.
- The patient who is suspected with poor compliance or disagrees to participate in the test.
- The patient who is considered by other investigators not to be suitable for participating in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Study site
Beijing
Shanghai General Hospital
Shanghai, Shanghai Municipality
About this study
Official title: Randomed and Double-blinded Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.
Read the detailed description
Primary observation indexes:
Hepatic fibrosis Ishak score after treatment decreases by the proportion not less than 1 compared with that before treatment.
Secondary observation indexes :
- Negative conversion ratio of HBV DNA after treatment (HBV DNA<1×103copies/mL) and falling range.
- The falling proportion of Fibrocan Kpa value after treatment compared with that before treatment.
- The falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment.
- The improvement of ALT of liver function.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Hydronidone, Placebo, Entecavir
- 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.
HydronidoneDrug
Also called F351
The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases.
PlaceboDrug
EntecavirDrug
| Study group | Role | What they receive |
|---|---|---|
| Hydronidone(180mg) & Entecavir & Placebo | Experimental | hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 2 capsules each time; with co-administration of placebo capsule, three times a day, 2 capsules each time, namely the daily dose of the investigational product is 180mg.
The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. Receives: Drug: Hydronidone; Drug: Placebo; Drug: Entecavir |
| Hydronidone(270mg) & Entecavir & Placebo | Experimental | hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 3 capsules each time; with co-administration of placebo capsule, three times a day, 1 capsules each time, namely the daily dose of the investigational product is 270mg.
The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. Receives: Drug: Hydronidone; Drug: Placebo; Drug: Entecavir |
| Hydronidone(360mg) & Entecavir | Experimental | hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 4 capsules each time; namely the daily dose of the investigational product is 360mg.
The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. Receives: Drug: Hydronidone; Drug: Entecavir |
| Entecavir & Placebo(360mg) | Experimental | placebo capsule 30mg/capsule placebo capsule, three times a day, 4 capsules each time. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. Receives: Drug: Placebo; Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hepatic fibrosis in chronic viral hepatitis B
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start25 Jun 2015
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
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 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LunGen Lu, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineJun Cheng, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499562
- Sponsor's protocol ID
- GNI-F351-201402
- Acronym
- HBV
- Status last verified
- Jun 2022
- First submitted
- 26 Jun 2015
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cai X, Liu X, Xie W, Ma A, Tan Y, Shang J, Zhang J, Chen C, Yu Y, Qu Y, Zhang L, Luo Y, Yin P, Cheng J, Lu L. Hydronidone for the Treatment of Liver Fibrosis Related to Chronic Hepatitis B: A Phase 2 Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1893-1901.e7. doi: 10.1016/j.cgh.2022.05.056. Epub 2022 Jul 13.
PubMed 35842120
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomed and Double-blinded Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
- ClinicalTrials.gov ID
- NCT02499562
- Acronym / sponsor ID
- HBV / GNI-F351-201402
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Shanghai Genomics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2015
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 16 Jul 2015 (estimated)
- 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.
To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.
Detailed description
Primary observation indexes:
Hepatic fibrosis Ishak score after treatment decreases by the proportion not less than 1 compared with that before treatment.
Secondary observation indexes :
- Negative conversion ratio of HBV DNA after treatment (HBV DNA<1×103copies/mL) and falling range.
- The falling proportion of Fibrocan Kpa value after treatment compared with that before treatment.
- The falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment.
- The improvement of ALT of liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hydronidone(180mg) & Entecavir & Placebo | Experimental | Drug: Hydronidone, Drug: Placebo, Drug: Entecavirhydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 2 capsules each time; with co-administration of placebo capsule, three times a day, 2 capsules each time, namely the daily dose of the investigational product is 180mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. |
| Hydronidone(270mg) & Entecavir & Placebo | Experimental | Drug: Hydronidone, Drug: Placebo, Drug: Entecavirhydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 3 capsules each time; with co-administration of placebo capsule, three times a day, 1 capsules each time, namely the daily dose of the investigational product is 270mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. |
| Hydronidone(360mg) & Entecavir | Experimental | Drug: Hydronidone, Drug: Entecavirhydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 4 capsules each time; namely the daily dose of the investigational product is 360mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. |
| Entecavir & Placebo(360mg) | Experimental | Drug: Placebo, Drug: Entecavirplacebo capsule 30mg/capsule placebo capsule, three times a day, 4 capsules each time. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-65, all genders.
- History of chronic hepatitis B, HBsAg positive≧six months.
- ALT<eight-fold ULN (maximum).
- Significant liver fibrosis confirmed by liver biopsy.
- HBeAg positive patients, HBV DNA>2.0×104 IU/mL (copies/mL); HBeAg negative patients，HBV DNA>2.0×103 IU/mL (104copies/mL).
Key exclusion criteria (18 listed)
- Failing to meet any one requirement of the inclusion criteria.
- Having suffered massive hemorrhage of gastrointestinal tract within 3 months before selection
- TBiL>three-fold ULN.
- AFP>100 ug/L
- PLT≦60×109/L
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 |
|---|---|---|
| HydronidoneAlso: F351The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases. | Drug | Hydronidone(180mg) & Entecavir & Placebo, Hydronidone(270mg) & Entecavir & Placebo, Hydronidone(360mg) & Entecavir |
| Placebo | Drug | Entecavir & Placebo(360mg), Hydronidone(180mg) & Entecavir & Placebo, Hydronidone(270mg) & Entecavir & Placebo |
| Entecavir | Drug | Entecavir & Placebo(360mg), Hydronidone(180mg) & Entecavir & Placebo, Hydronidone(270mg) & Entecavir & Placebo, Hydronidone(360mg) & Entecavir |
Primary outcome
Changes in hepatic fibrosis in chronic viral hepatitis B
Time frame: one year
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 23 Jun 2022.
- Derived from this study: PubMed 35842120Cai X, Liu X, Xie W, Ma A, Tan Y, Shang J, Zhang J, Chen C, Yu Y, Qu Y, Zhang L, Luo Y, Yin P, Cheng J, Lu L. Hydronidone for the Treatment of Liver Fibrosis Related to Chronic Hepatitis B: A Phase 2 Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1893-1901.e7. doi: 10.1016/j.cgh.2022.05.056. Epub 2022 Jul 13.
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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.
LunGen Lu principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Jun Cheng principal investigator
Beijing Ditan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydronidone and Entecavir in people with Hepatitis B, Chronic, run by Shanghai Genomics, Inc. at 2 sites 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 8 inclusion and 18 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 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in hepatic fibrosis in chronic viral hepatitis B (time frame: one year). 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 NCT02499562, 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 23 Jun 2022.