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HBsAg Related Response Guided Therapy (S-RGT)

Primary Purpose

Hepatitis B, Chronic

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Peginterferon alfa-2a

Entecavir

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Peginterferon alfa 2a, Entecavir, Response Guided Therapy, Chronic Hepatitis B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
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
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:

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.
Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab.
Diagnosed hepatic cellular carcinoma
Any evidence of decompensated liver disease (Childs B-C)

Sites / Locations

Shinchon Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Arm Label

HBsAg quantification>20,000 IU/ml

HBsAg<=1500IU/ml

HBsAg >1500 <=20,000 IU/ML

Arm Description

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

extend peginterferon alfa 2a until 48weeks

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

Outcomes

Primary Outcome Measures

HBeAg seroconversion

Secondary Outcome Measures

The changes of HBsAg titer

Full Information

NCT ID

NCT01456312

First Posted

October 15, 2011

Last Updated

October 29, 2012

Sponsor

Gangnam Severance Hospital

Collaborators

Roche Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT01456312

Brief Title

HBsAg Related Response Guided Therapy

Acronym

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:

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

February 2016 (Anticipated)

Study Completion Date

August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gangnam Severance Hospital

Collaborators

Roche Pharma AG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Chronic

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HBsAg quantification>20,000 IU/ml

Arm Type

Sham Comparator

Arm Description

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

Arm Title

HBsAg<=1500IU/ml

Arm Type

Sham Comparator

Arm Description

extend peginterferon alfa 2a until 48weeks

Arm Title

HBsAg >1500 <=20,000 IU/ML

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Peginterferon alfa-2a

Other Intervention Name(s)

Pegasys

Intervention Description

Duration and combination

Intervention Type

Drug

Intervention Name(s)

Entecavir

Other Intervention Name(s)

Baraclude Tab

Intervention Description

combination

Primary Outcome Measure Information:

Title

HBeAg seroconversion

Time Frame

24 weeks post treatment follow up

Secondary Outcome Measure Information:

Title

The changes of HBsAg titer

Time Frame

baseline and 24weeks post treatment follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years 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 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: 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. Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab. Diagnosed hepatic cellular carcinoma Any evidence of decompensated liver disease (Childs B-C)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kwansik Lee, professor

Phone

+82 11 9636 9935

leeks519@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kwansik Lee, professor

Organizational Affiliation

Gangnam Severance Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Shinchon Severance Hospital

City

Seoul

ZIP/Postal Code

120742

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sanghoon Ahn, professor

Phone

82-2-2228-1936

ahnsh@yuhs.ac

First Name & Middle Initial & Last Name & Degree

Sanhoon Ahn, Professor

12. IPD Sharing Statement

Learn more about this trial

HBsAg Related Response Guided Therapy

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