Nonalcoholic Fatty Liver DiseasePhase 4NCT06368882
Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）
A Phase 4 study testing Peg-Interferon α in people with Nonalcoholic Fatty Liver Disease and Chronic Hepatitis b, run by First Affiliated Hospital of Wenzhou Medical University at 5 sites in China.
Trial summary
This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Chronic Hepatitis b
- What is being tested?
- Peg-Interferon α
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2024to 31 Dec 2028
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18-60 years old, male or female (including 18 and 60 years old);
- meet the diagnostic criteria for chronic hepatitis B in the Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition), and meet the imaging diagnostic criteria for fatty liver in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 Update edition).
- serum HBsAg positive >6 months;
- NAs treatment: baseline HBsAg≤1500 IU/ml, HBeAg negative, HBV DNA negative (not detected);
- IHC initial treatment: baseline HBsAg<1000 IU/ml, HBeAg negative, HBV DNA negative (undetectable), ALT and AST persistently normal (ULN: <50 IU/L in men, <40 IU/L in women);
- a negative serum pregnancy test within 24 hours before the first dose (for women of reproductive age);
- willing to receive treatment and signed informed consent.
Who cannot join
- co-infection with active hepatitis A, C, D, E and/or HIV; Or combined with drug-induced liver injury, inherited metabolic liver disease, autoimmune hepatitis, alcoholic liver disease;
- Liver tumor was detected by liver imaging at the time of screening;
- patients diagnosed with hepatitis B cirrhosis, that is, those with liver biopsy pathology consistent with liver cirrhosis, or with two or more of the following five criteria, excluding non-cirrhotic portal hypertension: ① imaging examination showed signs of liver cirrhosis and/or portal hypertension; ② Esophagogastric varices were found by endoscopy; ③ Liver stiffness was consistent with cirrhosis; ④ Blood biochemical examination showed decreased albumin level (< 35 g/L) and/or prolonged prothrombin time (prolonged > 3 seconds compared with the control); ⑤ Blood routine examination showed platelet count < 100×109/L;
- pregnant or lactating women or those who plan to become pregnant and do not want to use contraception during the study period;
- neutrophil count <1.5×109/L or platelet count <90×109/L. Patients with creatinine higher than 1.5 times the upper limit of normal;
- The patients and their close relatives (parents, siblings, etc.) had a history of severe mental illness, especially depression. Severe psychosis is defined as severe depression or psychosis, suicide attempt, hospitalization due to psychosis, or a period of incapacitation due to psychosis;
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- patients with a history of immune-mediated diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies;
- patients with serious diseases of heart, lung, kidney, brain, blood and other important organs, and patients with other malignant tumors;
- history of severe epilepsy or current use of antiepileptic drugs. Control of unstable diabetes, hypertension, thyroid disease, etc. A history of severe retinopathy or other evidence of retinopathy;
- any history of organ transplantation and existing functional graft (except corneal or hair transplantation);
- patients who are allergic to interferon and its drug components, and who are not suitable for interferon according to the investigator's judgment;
- Patients deemed by the investigator to be ineligible for the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Ningbo No.2 Hospital
Ningbo
Hongshan Li, 13738865021
- Recruiting
Ruian People's Hospital
Rui’an
Liang Hong, 13958805550
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou
Chenwei Pan, 13587655994
- Recruiting
Wenzhou People's Hospital
Wenzhou
Ran Ding, 18057788513
- Recruiting
Yueqing People's Hospital
Yueqing
Hui Zhao, 13968713322
About this study
This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.
A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.
Read more
The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.
The security assessment includes adverse events, vital signs, and imaging.
- Being tested
- Peg-Interferon α
- Keywords
- Nonalcoholic Fatty Liver Disease, Chronic Hepatitis B, Peg-Interferon α, nucleo(s)tide analogues
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-Interferon αDrug
Also called nucleo(s)tide analogue
Peg IFN-α injection was subcutaneously injected 180 μg weekly on the first day of the first week, and NAs was administered daily according to the standard dosage of each drug. For example, HBsAg sero-conversion is achieved within 48 weeks of treatment, Peg IFNα combined with NAs or PEG-IFNα monotherapy was continued for 12 weeks, with a maximum of 96 weeks, and follow-up up to 240 weeks after treatment. If HBsAg negative sero-conversion is not achieved within 48 weeks of treatment, the maximum duration of PEG-IFNα is not more than 96 weeks. If Peg IFNα combined NAs regimen is used, NAs can be continued until the drug can be ended (if HBsAg negative conversion is achieved, NAs should be ended after consolidation therapy not less than 24 weeks; if HBsAg negative conversion is not achieved, NAS should be continued), followed up to 240 weeks after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Treatment Group [PEG-IFNα-based antiviral therapy (combined with NAs or PEG-IFNα monotherapy)]: PEG IFNα injection 180 μg is administrated subcutaneously on the first day of the first week, weekly; If HBsAg is negative within 48 weeks of treatment, Peg IFNα combined with NAs or PEG-IFNα monotherapy was continued for 12 weeks, with a maximum of 96 weeks, and the patients are followed up to 240 weeks after the end of treatment. If the patient doesn't achieve HBsAg negative conversion within 48 weeks of treatment, the maximum duration of Peg-IFNα treatment is 96 weeks, and the NAs treatment can be continued until the time of discontinuation where combined treatment programme is used (if HBsAg negative, the consolidation treatment for not less than 24 weeks, and if HBsAg positive still, the treatment with NAs continue). The total of duration of treatment or follow-up is 240 weeks after the end of treatment. Receives: Drug: Peg-Interferon α |
| Control Group | No intervention | Control group (receiving NAs monotherapy) : on the first day of the first week, daily, according to the standard dosage of each drug, until the time when the drug can be stopped (if HBsAg negative conversion is achieved, NAs should be ended after consolidation treatment for not less than 24 weeks; if HBsAg negative conversion is not achieved, NAs therapy should be continued), and follow-up up to 240 weeks after the end of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg clearance
HBsAg clearance at 48 weeks of treatment
Measured: 48 weeks
Secondary outcomes (4)
HBsAg clearance at 96 weeks
HBsAg clearance at 96 weeks of treatment
Measured: 96 weeks
Cumulative HBsAg clearance rate
The cumulative clearance rate of HBsAg in chronic hepatitis B patients with different degrees of hepatic steatosis at different treatment nodes; Stratified analysis was performed according to the CAP baseline at enrollment (mild, moderate and severe fatty liver) to explore the correlation between hepatic steatosis and HBsAg clearance rate under different antiviral treatment regimens.
Measured: week 24、72、120、144、168、192、216、240
Liver Function Tests
the level of ALT and AST
Measured: week 24、48、72、96、120、144、168、192、216、240
The incidence of liver cirrhosis and liver cancer
The incidence of liver cirrhosis and liver cancer
Measured: week 24、48、72、96、120、144、168、192、216、240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368882
- Sponsor's protocol ID
- Yongping _Chen
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）
- ClinicalTrials.gov ID
- NCT06368882
- Acronym / sponsor ID
- Yongping _Chen
- Keywords
- Nonalcoholic Fatty Liver Disease, Chronic Hepatitis B, Peg-Interferon α, nucleo(s)tide analogues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Apr 2024 (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 is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.
A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.
The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.
The security assessment includes adverse events, vital signs, and imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: Peg-Interferon αTreatment Group [PEG-IFNα-based antiviral therapy (combined with NAs or PEG-IFNα monotherapy)]: PEG IFNα injection 180 μg is administrated subcutaneously on the first day of the first week, weekly; If HBsAg is negative within 48 weeks of treatment, Peg IFNα combined with NAs or PEG-IFNα monotherapy was continued for 12 weeks, with a maximum of 96 weeks, and the patients are followed up to 240 weeks after the end of treatment. If the patient doesn't achieve HBsAg negative conversion within 48 weeks of treatment, the maximum duration of Peg-IFNα treatment is 96 weeks, and the NAs treatment can be continued until the time of discontinuation where combined treatment programme is used (if HBsAg negative, the consolidation treatment for not less than 24 weeks, and if HBsAg positive still, the treatment with NAs continue). The total of duration of treatment or follow-up is 240 weeks after the end of treatment. |
| Control Group | No intervention | –Control group (receiving NAs monotherapy) : on the first day of the first week, daily, according to the standard dosage of each drug, until the time when the drug can be stopped (if HBsAg negative conversion is achieved, NAs should be ended after consolidation treatment for not less than 24 weeks; if HBsAg negative conversion is not achieved, NAs therapy should be continued), and follow-up up to 240 weeks after the end of treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age of 18-60 years old, male or female (including 18 and 60 years old);
- meet the diagnostic criteria for chronic hepatitis B in the Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition), and meet the imaging diagnostic criteria for fatty liver in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 Update edition).
- serum HBsAg positive >6 months;
- NAs treatment: baseline HBsAg≤1500 IU/ml, HBeAg negative, HBV DNA negative (not detected);
- IHC initial treatment: baseline HBsAg<1000 IU/ml, HBeAg negative, HBV DNA negative (undetectable), ALT and AST persistently normal (ULN: <50 IU/L in men, <40 IU/L in women);
Key exclusion criteria (12 listed)
- co-infection with active hepatitis A, C, D, E and/or HIV; Or combined with drug-induced liver injury, inherited metabolic liver disease, autoimmune hepatitis, alcoholic liver disease;
- Liver tumor was detected by liver imaging at the time of screening;
- patients diagnosed with hepatitis B cirrhosis, that is, those with liver biopsy pathology consistent with liver cirrhosis, or with two or more of the following five criteria, excluding non-cirrhotic portal hypertension: ① imaging examination showed signs of liver cirrhosis and/or portal hypertension; ② Esophagogastric varices were found by endoscopy; ③ Liver stiffness was consistent with cirrhosis; ④ Blood biochemical examination showed decreased albumin level (< 35 g/L) and/or prolonged prothrombin time (prolonged > 3 seconds compared with the control); ⑤ Blood routine examination showed platelet count < 100×109/L;
- pregnant or lactating women or those who plan to become pregnant and do not want to use contraception during the study period;
- neutrophil count <1.5×109/L or platelet count <90×109/L. Patients with creatinine higher than 1.5 times the upper limit of normal;
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 |
|---|---|---|
| Peg-Interferon αAlso: nucleo(s)tide analoguePeg IFN-α injection was subcutaneously injected 180 μg weekly on the first day of the first week, and NAs was administered daily according to the standard dosage of each drug. For example, HBsAg sero-conversion is achieved within 48 weeks of treatment, Peg IFNα combined with NAs or PEG-IFNα monotherapy was continued for 12 weeks, with a maximum of 96 weeks, and follow-up up to 240 weeks after treatment. If HBsAg negative sero-conversion is not achieved within 48 weeks of treatment, the maximum duration of PEG-IFNα is not more than 96 weeks. If Peg IFNα combined NAs regimen is used, NAs can be continued until the drug can be ended (if HBsAg negative conversion is achieved, NAs should be ended after consolidation therapy not less than 24 weeks; if HBsAg negative conversion is not achieved, NAS should be continued), followed up to 240 weeks after treatment. | Drug | Treatment Group |
Primary outcome
HBsAg clearance
Time frame: 48 weeks
HBsAg clearance at 48 weeks of treatment
4 secondary outcomes
HBsAg clearance at 96 weeks
Time frame: 96 weeks
Cumulative HBsAg clearance rate
Time frame: week 24、72、120、144、168、192、216、240
Liver Function Tests
Time frame: week 24、48、72、96、120、144、168、192、216、240
The incidence of liver cirrhosis and liver cancer
Time frame: week 24、48、72、96、120、144、168、192、216、240
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 16 Apr 2024.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peg-Interferon α in people with Nonalcoholic Fatty Liver Disease and Chronic Hepatitis b, run by First Affiliated Hospital of Wenzhou Medical University at 5 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yongping Chen, Professor (13505777281, 13505777281@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg clearance (time frame: 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 16 Apr 2024.