HBsAg Related Response Guided Therapy

Hepatitis B, Chronic Clinical Trial

— S-RGT  

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:

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01456312
• Other study ID #: ML25588
• Status: Recruiting
• Phase: Phase 4
• First received: October 15, 2011
• Last updated: October 29, 2012
• Start date: September 2012
• Est. completion date: August 2016

Study information

• Verified date: October 2012
• Source: Gangnam Severance Hospital
• Contact: Kwansik Lee, professor
• Phone: +82 11 9636 9935
• Email: leeks519[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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 ⅲ. The rate of serum HBV DNA < 300 copies/mL

• The rate of ALT normalization ⅴ. The rate of HBsAg loss ⅵ. The rate of serum HBV DNA < 10,000 copies/mL

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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Peginterferon alfa-2a
Duration and combination
• Entecavir
combination

Locations

Country	Name	City	State
Korea, Republic of	Shinchon Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Gangnam Severance Hospital	Roche Pharma AG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBeAg seroconversion		24 weeks post treatment follow up	No
Secondary	The changes of HBsAg titer		baseline and 24weeks post treatment follow up	No