Chronic Hepatitis B Patients With a Normal ALT Level and Low ViremiaPhase 1/2NCT05203055
Peginterferon Alpha-2b Therapy in Chronic Hepatitis Patients With Normal ALT Level and Low Viremia
A Phase 1/2 study testing Peginterferon alpha-2b, Nucleotide Analog and pulse peginterferon alpha-2b in people with Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia, run by Fuzhou General Hospital at 1 site in China.
Trial summary
To date, antiviral treatment is not recommended for chronic hepatitis B patients with a normal ALT level and low viremia. The strategy is to closely monitor the patients. However, evidence suggests that these group are at risk of gradual disease progression and development of hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia
- What is being tested?
- Peginterferon alpha-2b, Nucleotide Analog and pulse peginterferon alpha-2b
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2021to 10 Dec 2023
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- willing to receive the treatment and sign informed consent;
- 18-60 years old (including 18 and 60), both gender;
- HBsAg positive for at least 6 months and <1500IU/ml;
- ALT≤1xULN and no elevated ALT has been detected in history;
- HBV DNA detectable but<2000 IU/ml;
- HBeAg negative ;
Who cannot join
- For female participants: positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. For male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of the contraception ;
- neuropsychiatric diseases, such as depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially with a history of depression or depression tendency);
- co-infection of HCV, EBV, other hepatotropic viruses , non-hepatotropic viruses;
- alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease;
- Patients with moderate to severe steatohepatitis;
- possibility of liver cirrhosis that cannot be excluded
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- hepatocellular carcinoma or AFP level>30ng/ml;
- Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, serum creatinine> 1 x ULN at the time of screening;
- at screening, the neutrophil count is less than 1.5×10^9/L, and the platelet count is less than 90×10^9/L;
- Serum phosphorus level <0.7 mmol/L;
- Antinuclear antibody (ANA)>1:100;
- Autoimmune diseases, including thyroiditis, psoriasis and systemic lupus erythematosus;
- Endocrine system diseases, including thyroid diseases and diabetes mellitus;
- Uncontrolled blood pressure: SBP>160 mmHg or DBP >100 mmHg at the time of enrollment;
- Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months;
- Severe retinopathy or other serious eye diseases;
- Organic disease or dysfunction;
- plan to receive an organ transplant or have already undergone an organ transplant;
- received standardized treatment with interferon or NA products before .
- allergic to interferon or pharmaceutical excipients, or meet any of the contraindications in the experimental drug instructions;
- Participated in other interventional trials within 3 months before the screening or other conditions deemed unsuitable by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, 350025
Dongliang Li, Dr., dongliangli93@163.com
Dongliang Li, Dr.
About this study
Official title: A Multi-center, Open-label Study to Elucidate the Efficacy and Safety of Peginterferon Alpha-2b Therapy in the Initial Treatment of Chronic Hepatitis Patients With Normal ALT Level and Low Viremia
To date, antiviral treatment is not recommended for chronic hepatitis B patients with a normal ALT level and low viremia. The strategy is to closely monitor the patients. However, evidence suggests that these group are at risk of gradual disease progression and development of hepatocellular carcinoma. Peginterferon eliminates the hepatitis B virus through immune regulation and induction of antiviral protein expression. For patients with low viral load, the clinical cure rate is potentially promising. In this study, we aim to investigate the efficacy and safety of peginterferon alpha-2b therapy in selected chronic hepatitis B patients with normal ALT level and low viremia. It is expected to obtain a satisfactory curative effect. Peginterferon is a marketed drug available in Chinese clinics with indications of anti-hepatitis B virus.
- Being tested
- Peginterferon alpha-2b, Nucleotide Analog, pulse peginterferon alpha-2b
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alpha-2bDrug
180μg/w
Nucleotide AnalogDrug
Etecavir 0.5mg qd or Tenofovir 300mg qd
pulse peginterferon alpha-2bDrug
180μg/w for 8 consecutive weeks and cessation for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| monotherapy group | Experimental | Peginterferon alpha-2b injection is given subcutaneously at a dosage of 180μg/w for 48 consecutive weeks. Patients will stop the treatment whenever HBsAg is eliminated, and those without HBsAg elimination after 48 dosages will enter the group of best treatment. The patients will be followed up for another 24 weeks after treatment. Receives: Drug: Peginterferon alpha-2b |
| continuous combination therapy group | Experimental | Peginterferon alpha-2b injection is given subcutaneously at a dosage of 180μg/w for 48 consecutive weeks, plus continuous oral NA. Patients will stop the treatment whenever HBsAg is eliminated, and those without HBsAg elimination after 48 dosages will enter the group of best treatment. The patients will be followed up for another 24 weeks after treatment. Receives: Drug: Peginterferon alpha-2b; Drug: Nucleotide Analog |
| pulse combination therapy group | Experimental | Peginterferon alpha-2b injection is given subcutaneously at a dosage of 180μg/w for 8 consecutive weeks and cessation for 4 weeks,plus continuous oral NA. Patients will discontinue the treatment at any time if they are recovery, and those without HBsAg elimination after 48 dosages will enter the group of best treatment.The patients will be followed up for another 24 weeks after treatment. Receives: Drug: Peginterferon alpha-2b; Drug: pulse peginterferon alpha-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with undetectable HBV DNA
Measured: week 24
HBsAg clearance rate
Measured: week 48
HBsAg conversion rate
Measured: week 48
Secondary outcomes (3)
The percentage of patients with undetectable HBV DNA
Measured: week 24 and week 48
The HBsAg level
Measured: week 24 and week 48
The HBV pgRNA level
Measured: week 24 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start10 Dec 2021
- Primary completion10 Dec 2022 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Patients With a Normal ALT Level and Low ViremiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203055
- Sponsor's protocol ID
- Peginterferon alpha-2b-HBV
- Status last verified
- Dec 2021
- First submitted
- 18 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Study to Elucidate the Efficacy and Safety of Peginterferon Alpha-2b Therapy in the Initial Treatment of Chronic Hepatitis Patients With Normal ALT Level and Low Viremia
- ClinicalTrials.gov ID
- NCT05203055
- Acronym / sponsor ID
- Peginterferon alpha-2b-HBV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 24 Jan 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.
To date, antiviral treatment is not recommended for chronic hepatitis B patients with a normal ALT level and low viremia. The strategy is to closely monitor the patients. However, evidence suggests that these group are at risk of gradual disease progression and development of hepatocellular carcinoma. Peginterferon eliminates the hepatitis B virus through immune regulation and induction of antiviral protein expression. For patients with low viral load, the clinical cure rate is potentially promising. In this study, we aim to investigate the efficacy and safety of peginterferon alpha-2b therapy in selected chronic hepatitis B patients with normal ALT level and low viremia. It is expected to obtain a satisfactory curative effect. Peginterferon is a marketed drug available in Chinese clinics with indications of anti-hepatitis B virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| monotherapy group | Experimental | Drug: Peginterferon alpha-2bPeginterferon alpha-2b injection is given subcutaneously at a dosage of 180μg/w for 48 consecutive weeks. Patients will stop the treatment whenever HBsAg is eliminated, and those without HBsAg elimination after 48 dosages will enter the group of best treatment. The patients will be followed up for another 24 weeks after treatment. |
| continuous combination therapy group | Experimental | Drug: Peginterferon alpha-2b, Drug: Nucleotide AnalogPeginterferon alpha-2b injection is given subcutaneously at a dosage of 180μg/w for 48 consecutive weeks, plus continuous oral NA. Patients will stop the treatment whenever HBsAg is eliminated, and those without HBsAg elimination after 48 dosages will enter the group of best treatment. The patients will be followed up for another 24 weeks after treatment. |
| pulse combination therapy group | Experimental | Drug: Peginterferon alpha-2b, Drug: pulse peginterferon alpha-2bPeginterferon alpha-2b injection is given subcutaneously at a dosage of 180μg/w for 8 consecutive weeks and cessation for 4 weeks,plus continuous oral NA. Patients will discontinue the treatment at any time if they are recovery, and those without HBsAg elimination after 48 dosages will enter the group of best treatment.The patients will be followed up for another 24 weeks after treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- willing to receive the treatment and sign informed consent;
- 18-60 years old (including 18 and 60), both gender;
- HBsAg positive for at least 6 months and <1500IU/ml;
- ALT≤1xULN and no elevated ALT has been detected in history;
- HBV DNA detectable but<2000 IU/ml;
Key exclusion criteria (21 listed)
- For female participants: positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. For male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of the contraception ;
- neuropsychiatric diseases, such as depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially with a history of depression or depression tendency);
- co-infection of HCV, EBV, other hepatotropic viruses , non-hepatotropic viruses;
- alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease;
- Patients with moderate to severe steatohepatitis;
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 |
|---|---|---|
| Peginterferon alpha-2b180μg/w | Drug | continuous combination therapy group, monotherapy group, pulse combination therapy group |
| Nucleotide AnalogEtecavir 0.5mg qd or Tenofovir 300mg qd | Drug | continuous combination therapy group |
| pulse peginterferon alpha-2b180μg/w for 8 consecutive weeks and cessation for 4 weeks | Drug | pulse combination therapy group |
Primary outcome
The percentage of patients with undetectable HBV DNA
Time frame: week 24
HBsAg clearance rate
Time frame: week 48
HBsAg conversion rate
Time frame: week 48
3 secondary outcomes
The percentage of patients with undetectable HBV DNA
Time frame: week 24 and week 48
The HBsAg level
Time frame: week 24 and week 48
The HBV pgRNA level
Time frame: week 24 and week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Peginterferon alpha-2b, Nucleotide Analog and pulse peginterferon alpha-2b in people with Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia, run by Fuzhou General 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 6 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 24 Jan 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongliang Li, Professor (008613665052006, dongliangli93@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with undetectable HBV DNA (time frame: week 24). The study lists 3 primary outcomes in all. 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 24 Jan 2022.