Clinical trial NCT01456312: HBsAg Related Response Guided Therapy
Official title: 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:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Peginterferon alfa 2a
Entecavir
Response Guided Therapy
Chronic Hepatitis B
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2011-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: HBeAg seroconversion
timeFrame: 24 weeks post treatment follow up
Secondary outcomes:
measure: The changes of HBsAg titer
timeFrame: baseline and 24weeks post treatment follow up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Shinchon Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Kwansik Lee, professor
role: STUDY_CHAIR
References: