Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments peg-interferon-alfa-2a, nucleosides
Phase phase 3
Sponsor Pusan National University Hospital
Start date May 2013
End date May 2015
Trial size 144 participants
Trial identifier NCT01769833, ML25659

Summary

This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg levels in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients who have an undetectable hepatitis B virus (HBV) viral load at least 1 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
PEG-interferon-alfa 2A
peg-interferon-alfa-2a Pegasys (PEG-interferon-Alfa-2A)
Pegasys ( PEG-interferon-Alfa-2A) 180mcg / subcutaneous / once-weekly
(Placebo Comparator)
Nucleosides
nucleosides

Primary Outcomes

Measure
Change in log10 HBsAg titer during antiviral therapy
time frame: 48 week

Secondary Outcomes

Measure
HBV DNA undetectability and below 400 IU/mL during antiviral therapy and follow-up
time frame: 48 week, 96 week
HBeAg seroconversion and loss during antiviral therapy and at end of treatment and 1 and 2 years following end of treatment
time frame: 48 week, 96 week
HBsAg loss and HBsAg seroconversion at end of treatment and 1 and 2 years following end of treatment
time frame: 48 week, 96 week
Change in log10 HBsAg titer during follow-up
time frame: 48 week, 96 week
Mean change in log10 HBsAg titre over time, as estimated from the area between the baseline value and the curve of log10 HBsAg titre divided by the duration of treatment
time frame: 48 week

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Informed consent - Age over 20 years - HBeAg-positive CHB patients - Patients treated with all available nucleoside analogue monotherapy or combination in Korea except telbivudine ( e.g.entecavir monotherapy or lamivudine/adefovir combination , lamivudine, adefovir monotherapy) for ≥ 18months and patients who have undetectable HBV viral load at least one year HBV DNA undetectable (≤ 400 copies/ml ) Serum alanine transferase: ≤ 10 X upper limit of normal (ULN) Baseline HBsAg: ≥ 102 IU/ml - Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion. - Obtaining written informed consent form Exclusion Criteria: - Decompensated cirrhosis or other contraindications to interferon alfa 2a therapy following local label. - Concomitant or prior use of telbivudine. - Positive test at screening for hepatitis A virus immunoglobulin M Ab, Hepatitis C virus-RNA or hepatitis C virus Ab, hepatitis delta virus Ab or HIV Ab. - Diagnosed hepatic cellular carcinoma - Any evidence of decompensated liver disease (Childs B-C) - History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia). - Women with ongoing pregnancy or who are breast feeding. - Evidence of alcohol and/or drug abuse within one year of entry. - History of major organ transplantation with an existing functional graft. - Inability or unwillingness to provide informed consent or abide by the requirements of the study. - History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study. - Patients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months. - patients having hypersensitivities for peginterferon alfa-2a or NAs

Additional Information

Official title HBsAg Decline and HBeAg Seroconversion Following 48 Weeks Peg-interferon-α Treatment in Patients With e Antigen Positive Chronic Hepatitis B After Nucleoside Analogue Maintenance Therapy Compared to Continuing Nucleoside Analogue Treatment
Principal investigator Jeong Heo, Dr
Description Pegylated interferon after long term NA therapy will potentiate the antiviral efficacy directly via its effect on broad antiviral activities and indirectly via activation of innate and adaptive immune responses leading to HBeAg seroconversion and eventually HBsAg loss and/or seroconversion. This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. NA on HBeAg seroconversion and HBsAg levels in NA controlled HBeAg-positive CHB patients who have an undetectable HBV viral load at least 1 years.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Pusan National University Hospital.