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The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02745704
Enrollment
200
Registered
2016-04-20
Start date
2016-04-30
Completion date
2019-04-30
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B, peginterferon alfa

Brief summary

As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

Detailed description

In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 weeks.

Interventions

DRUGPeginterferon alfa

peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week

Sponsors

Peking University
CollaboratorOTHER
Huazhong University of Science and Technology
CollaboratorOTHER
Nanchang University
CollaboratorOTHER
Huizhou Municipal Central Hospital
CollaboratorOTHER
First People's Hospital, Shunde China
CollaboratorOTHER
Shenzhen Third People's Hospital
CollaboratorOTHER
First People's Hospital of Foshan
CollaboratorOTHER
Tang-Du Hospital
CollaboratorOTHER
First Affiliated Hospital of Kunming Medical University
CollaboratorOTHER
Yuebei People's Hospital
CollaboratorOTHER
Third Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. CHB patients who had received NAs for more than 12 months. 2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive. 3. Hepatitis B surface antigen (HBsAg) positive and \<1500 IU/mL. 4. Hepatitis B virus DNA not detectable(Roche Cobas).

Exclusion criteria

1. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies. 2. Patients with other factors causing liver diseases. 3. Pregnant and lactating women. 4. Patients with concomitant HIV infection or congenital immune deficiency diseases. 5. Patients with diabetes, autoimmune diseases. 6. Patients with important organ dysfunctions. 7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.) 8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months. 9. Patients who can't come back to clinic for follow-up on schedule.

Design outcomes

Primary

MeasureTime frameDescription
HBsAg Clearance72 weeksPercentage of Participants with HBsAg negative.
HBsAg Seroconversion72 weeksPercentage of Participants with HBsAg negative and anti-HBsAg positive.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026