HBsAg Related Response Guided Therapy (S-RGT)

Yonsei University Health System (YUHS)

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Entecavir; Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01456312

ML25588

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

HBsAg quantification>20,000 IU/ml

Sham Comparator group

Description:

stop peginterferon alfa 2a if patients reach HBsAg quantification\>20,000 Iu/ml at 12w

Treatment:

Drug: Peginterferon alfa-2a

HBsAg<=1500IU/ml

Sham Comparator group

Description:

extend peginterferon alfa 2a until 48weeks

Treatment:

Drug: Peginterferon alfa-2a

HBsAg >1500 <=20,000 IU/ML

Sham Comparator group

Description:

add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w

Treatment:

Drug: Entecavir

Drug: Peginterferon alfa-2a