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Peginterferon Alpha-2b Therapy in Chronic Hepatitis Patients With Normal ALT Level and Low Viremia

Primary Purpose

Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Peginterferon alpha-2b
Nucleotide Analog
pulse peginterferon alpha-2b
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. willing to receive the treatment and sign informed consent;
  2. 18-60 years old (including 18 and 60), both gender;
  3. HBsAg positive for at least 6 months and <1500IU/ml;
  4. ALT≤1xULN and no elevated ALT has been detected in history;
  5. HBV DNA detectable but<2000 IU/ml;
  6. HBeAg negative ;

Exclusion Criteria:

  1. 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 ;
  2. neuropsychiatric diseases, such as depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially with a history of depression or depression tendency);
  3. co-infection of HCV, EBV, other hepatotropic viruses , non-hepatotropic viruses;
  4. alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease;
  5. Patients with moderate to severe steatohepatitis;
  6. possibility of liver cirrhosis that cannot be excluded
  7. hepatocellular carcinoma or AFP level>30ng/ml;
  8. Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, serum creatinine> 1 x ULN at the time of screening;
  9. at screening, the neutrophil count is less than 1.5×10^9/L, and the platelet count is less than 90×10^9/L;
  10. Serum phosphorus level <0.7 mmol/L;
  11. Antinuclear antibody (ANA)>1:100;
  12. Autoimmune diseases, including thyroiditis, psoriasis and systemic lupus erythematosus;
  13. Endocrine system diseases, including thyroid diseases and diabetes mellitus;
  14. Uncontrolled blood pressure: SBP>160 mmHg or DBP >100 mmHg at the time of enrollment;
  15. Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months;
  16. Severe retinopathy or other serious eye diseases;
  17. Organic disease or dysfunction;
  18. plan to receive an organ transplant or have already undergone an organ transplant;
  19. received standardized treatment with interferon or NA products before .
  20. allergic to interferon or pharmaceutical excipients, or meet any of the contraindications in the experimental drug instructions;
  21. Participated in other interventional trials within 3 months before the screening or other conditions deemed unsuitable by the investigator.

Sites / Locations

  • Fuzhou General Hospital, Xiamen UnivRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

monotherapy group

continuous combination therapy group

pulse combination therapy group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

The percentage of patients with undetectable HBV DNA
HBsAg clearance rate
HBsAg conversion rate

Secondary Outcome Measures

The percentage of patients with undetectable HBV DNA
The HBsAg level
The HBV pgRNA level

Full Information

First Posted
December 18, 2021
Last Updated
January 21, 2022
Sponsor
Fuzhou General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05203055
Brief Title
Peginterferon Alpha-2b Therapy in Chronic Hepatitis Patients With Normal ALT Level and Low Viremia
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
December 10, 2022 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuzhou General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
monotherapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
continuous combination therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
pulse combination therapy group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alpha-2b
Intervention Description
180μg/w
Intervention Type
Drug
Intervention Name(s)
Nucleotide Analog
Intervention Description
Etecavir 0.5mg qd or Tenofovir 300mg qd
Intervention Type
Drug
Intervention Name(s)
pulse peginterferon alpha-2b
Intervention Description
180μg/w for 8 consecutive weeks and cessation for 4 weeks
Primary Outcome Measure Information:
Title
The percentage of patients with undetectable HBV DNA
Time Frame
week 24
Title
HBsAg clearance rate
Time Frame
week 48
Title
HBsAg conversion rate
Time Frame
week 48
Secondary Outcome Measure Information:
Title
The percentage of patients with undetectable HBV DNA
Time Frame
week 24 and week 48
Title
The HBsAg level
Time Frame
week 24 and week 48
Title
The HBV pgRNA level
Time Frame
week 24 and week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 ; Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongliang Li, Professor
Phone
008613665052006
Email
dongliangli93@163.com
Facility Information:
Facility Name
Fuzhou General Hospital, Xiamen Univ
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongliang Li, Dr.
Email
dongliangli93@163.com
First Name & Middle Initial & Last Name & Degree
Dongliang Li, Dr.

12. IPD Sharing Statement

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Peginterferon Alpha-2b Therapy in Chronic Hepatitis Patients With Normal ALT Level and Low Viremia

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