The Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC

NCT03084250 | Unknown Phase 4

• 1 other identifier: High risk of HCC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The CHB subjects who are cirrhosis, will be randomized to two groups. The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks. The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Number of subjects who develop to hepatocellular carcinoma during 5 years

  The number of subjects develop to hepatocellular carcinoma during 5 years will be measured

  5 years

Secondary Outcomes (3)

• Number of participants who achieve HBeAg loss and HBeAg seroconversion

  year 1,2,3,4,5

• Number of participants who achieve HBsAg loss and HBsAg seroconversion

  year 1,2,3,4,5

• The factor such as HBsAg level related to the incidence of HCC development

  year 1

Study Arms (2)

Combination

EXPERIMENTAL

The subjects will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a

Drug: Peginterferon Alfa-2A

nucleotide analogue

ACTIVE COMPARATOR

The subjects will be treated by nucleotide analogue (NA) only

Drug: Adefovir, entecavir,tenofovir, either of them

Interventions

Peginterferon Alfa-2A DRUG

180μg/week, 48 weeks; 135μg/week,48weeks

Also known as: Pegasys

Combination

Adefovir, entecavir,tenofovir, either of them DRUG

Adefovir, entecavir,tenofovir, either of them is ok

nucleotide analogue

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with age ≥18 and ≤65 years;
• There should be evidences that HBsAg has been positive for more than 6 months with HBsAb and HBeAb negative; HBV-related cirrhosis
• Women without ongoing pregnancy or breast feeding and both women and men willing to take an effective contraceptive measure during the treatment;
• Agree to participate in the study and sign the patient informed consent form.

You may not qualify if:

• Treated by immunosuppressant,immunomodulator,Systemic cytotoxic drug,herbs or HBIg within 6 months prior to the first dose of treatment;
• ALT≥10 X ULN or total bilirubin ≥2 X ULN;
• Allergic history to interferon;
• Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
• Child-Pugh scores \>7;
• History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
• Pregnant or breast-feeding Women;
• Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment or drug taking history;
• ANC(absolute neutrophil count)\<1.5x 10\^9/L or PLT(platelet count)\<90x 10\^9/L
• Creatinine over upper limit of normal;
• History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis that treated with antidepressant medication or a major tranquilizer at therapeutic doses respectively at any time prior to 3 months or any history of the following: a suicidal attempt hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease;
• History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
• History of esophageal varices bleeding or other evidence of esophageal varices bleeding or other symptoms consistent with decompensated liver disease;
• History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases);
• Hemodialysis patients or patients with renal insufficiency;

Sponsors & Collaborators

• Shanghai Nanhui Nanhua Hospital: lead

Study Sites (1)

Nanhua Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

peginterferon alfa-2a; adefovir; entecavir; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chenbo Hu

  Nanhua Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Chenbo Hu

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: March 10, 2017
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

CN (1)