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

NCT05203055 | Unknown Phase 1 DMC

• 1 other identifier: Peginterferon alpha-2b-HBV
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• The percentage of patients with undetectable HBV DNA

  week 24

• HBsAg clearance rate

  week 48

• HBsAg conversion rate

  week 48

Secondary Outcomes (3)

• The percentage of patients with undetectable HBV DNA

  week 24 and week 48

• The HBsAg level

  week 24 and week 48

• The HBV pgRNA level

  week 24 and week 48

Study Arms (3)

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.

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.

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.

Drug: Peginterferon alpha-2b; Drug: pulse peginterferon alpha-2b

Interventions

Peginterferon alpha-2b DRUG

180μg/w

continuous combination therapy group; monotherapy group; pulse combination therapy group

Nucleotide Analog DRUG

Etecavir 0.5mg qd or Tenofovir 300mg qd

continuous combination therapy group

pulse peginterferon alpha-2b DRUG

180μg/w for 8 consecutive weeks and cessation for 4 weeks

pulse combination therapy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• willing to receive the treatment and sign informed consent;
• 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 ;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

Fuzhou General Hospital, Xiamen Univ

Fuzhou, Fujian, 350025, China

RECRUITING

MeSH Terms

Interventions

peginterferon alfa-2b; Nucleotides

Intervention Hierarchy (Ancestors)

Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Dongliang Li, Professor

CONTACT

008613665052006; dongliangli93@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: January 24, 2022
• Study Start: December 10, 2021
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2023
• Last Updated: January 24, 2022

Record last verified: 2021-12

Locations

CN (1)