HBsAg Related Response Guided Therapy

A Multi Center, Phase IIIb Study to Evaluate the Efficacy of Response Guided Therapy Using Quantitative HBsAg Measurement in Patient With HBeAg Positive Chronic Hepatitis B:

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456312

Acronym

S-RGT

Enrollment

200

Registered

2011-10-20

Start date

2012-09-30

Completion date

2016-08-31

Last updated

2012-10-31

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

Conditions

Hepatitis B, Chronic

Keywords

Peginterferon alfa 2a, Entecavir, Response Guided Therapy, Chronic Hepatitis B

Brief summary

Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up) Secondary objective : * The changes of HBsAg titer * The rate of combined HBeAg seroconversion and HBV DNA \< 300 copies/mL * The rate of serum HBV DNA \< 300 copies/mL ⅳ. The rate of ALT normalization * The rate of HBsAg loss ⅵ. The rate of serum HBV DNA \< 10,000 copies/mL

Detailed description

After 12w treatment of Pegasys, depends on results of quantitative HBsAg test, Patients will be allocated to one of three groups. * HBsAg \>20,000 : study termination * Group A :1,500\<HBsAg≤ 20,000 * Group B : .HBsAg ≤ 1500 At week 48, according to HbeAg seroconversion, patients will be allocated to one of two sub-groups(A-1, A-2, B-1, B-2) Patients are seen for evaluation at treatment weeks 4,8,12,24,36,48. Post-treatment assessments will be performed at 4,12 and 24 week during off-treatment phase for the assessment of the primary and main secondary endpoints of the study.

Interventions

DRUGPeginterferon alfa-2a

Duration and combination

DRUGEntecavir

combination

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 18 years 2. Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA(patients must have \> 100,000 copies/ml as measured by PCR) and anti-HBs negative 3. Elevated serum ALT \> 2ULN but ≤ 10 × ULN as determined by two abnormal values taken ≥ 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.

Exclusion criteria

1. Patients must not have received antiviral therapy for their chronic hepatitis B. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had less than 6 months treatment of NA(Nucleos(t)ide analog) and more than 1 year wash-out period for systemic antiviral therapy and negative results in the NA resistance test at baseline are not excluded. 2. Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab. 3. Diagnosed hepatic cellular carcinoma 4. Any evidence of decompensated liver disease (Childs B-C)

Design outcomes

Primary

Measure	Time frame
HBeAg seroconversion	24 weeks post treatment follow up

Secondary

Measure	Time frame
The changes of HBsAg titer	baseline and 24weeks post treatment follow up

Countries

South Korea

Contacts

Primary ContactKwansik Lee, professor

leeks519@yuhs.ac+82 11 9636 9935

Outcome results

None listed

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