Peg-interferon for Inactive Chronic Hepatitis B Carriers

NCT02992704 | Completed Phase 2

• 1 other identifier: 2014/00205
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Hepatitis B carriers (normal LFTs and viral load \< 2 x 10\^4 IU/ml are not recommended to be treated by guidelines as they are at low risk for complications. However, it is unclear if treatment can enhance HBsAg loss which has been shown to be associated with significantly lower risk of complications compared to those without HBsAg loss. Consequently, this is a proof of concept study to determine the possibility of HBsAg loss in Chronic Hepatitis B carriers in a randomised open label clinical trial comparing no treatment to 24 weeks peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on therapy and matched to an equivalent timepoint in the control arm. The sample size calculation is 30 patients in each arm for a 20% difference between any experimental arm and the control arm.

Conditions

Chronic Hepatitis, B Virus; Carrier of Viral Hepatitis Type B

Outcome Measures

Primary Outcomes (1)

• HBsAg loss

  Qualitative HBsAg assay reads "non-detectable"

  24 weeks after end of therapy

Secondary Outcomes (3)

• HBsAg loss

  At the end of 24 and 48 weeks of peginterferon therapy

• Decline in quantitative HBsAg level

  At week 24, 48 and 24 weeks after completion of therapy

• proportion of patients with undetectable HBV DNA

  At week 24, 48 of therapy, and 24 weeks after end of therapy

Study Arms (3)

PEG 24 weeks

EXPERIMENTAL

peginterferon alpha 2a 180mcg for 24 weeks

Drug: Peginterferon Alfa-2A

PEG 48 weeks

EXPERIMENTAL

peginterferon alpha 2a 180mcg 48 weeks

Drug: Peginterferon Alfa-2A

Control

NO INTERVENTION

No treatment for 72 weeks

Interventions

Peginterferon Alfa-2A DRUG

peginterferon alpha 2a 180mcg weekly for either 24 or 48 weeks

Also known as: pegasys

PEG 24 weeks; PEG 48 weeks

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment naïve
• Documented HBsAg or HBV DNA positive for ≥ 6 months.
• Documented HBeAg negative and anti-HBe positive
• ALT ≤1xULN
• quantitative HBsAg \<1,000 IU/ml
• HBV DNA \<2x104 IU/mL at screening
• Absence of cirrhosis documented by liver biopsy or transient elastography within 6 months (Fibroscan®; Fibrosis stage \>2 (score ≥ 10Kpa) will not be eligible for this study.)
• Patient has agreed not to take any other investigational drug or systemic anti-viral, cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies unless clinically indicated.
• Patient is able to give written consent prior to study start and to comply with the study requirements.
• Women of childbearing age must have a negative urine (ß-HCG) pregnancy test taken within 14 days of starting therapy

You may not qualify if:

• Patients who are currently on treatment with nucleoside/nucleotide analogues or have been treated for Hepatitis B in the past
• Presence of cirrhosis documented by liver biopsy or transient elastography (score ≥ 10kpa)
• Active Co-infection with HIV antibody, HCV antibody or HDV antibody positivity.
• Evidence of decompensated liver disease defined as a direct (conjugated) bilirubin \>1.2x upper limit of normal (ULN), prothrombin time (PT) \>1.5xULN , serum bilirubin \<35g/L, or prior history of clinical hepatic decompensation as illustrated by presence of (eg. ascites, encephalopathy, variceal haemorrhage)
• Evidence of hepatocellular carcinoma
• Absolute neutrophil count \<1.5x10\^9/L or Hemoglobin \<12 g/L for men or \<11 g/L for women, or platelet count \< 90x10\^9/L
• History of depression or psychiatric disease
• Uncontrolled thyroid disease defined as thyroid-stimulating hormone (TSH) \>1.2 ULN or 0.8xLLN or thyroid dysfunction
• Any immunomodulators, systemic cytotoxic agents, or systemic cortiosteriods within 6 months before trial entry
• Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures)
• Malignant disease within 5 years of trial entry
• Women who are pregnant and who are not practicing adequate birth control measures, (defined as two methods of birth control with at least one barrier method) or who are lactating.

Sponsors & Collaborators

• Seng Gee Lim: lead
• Roche Pharma AG: collaborator

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seng Gee Lim, MBBS, FRACP, FRCP, MD

  National University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Hepatology

Model Details: Three arm, parallel open label study

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 14, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)