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HBsAg Related Response Guided Therapy (S-RGT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01456312
Recruitment Status : Unknown
Verified October 2012 by Kwan Sik Lee, Gangnam Severance Hospital.
Recruitment status was:  Recruiting
First Posted : October 20, 2011
Last Update Posted : October 31, 2012
Roche Pharma AG
Information provided by (Responsible Party):
Kwan Sik Lee, Gangnam Severance Hospital

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 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

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Peginterferon alfa-2a Drug: Entecavir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2012
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sham Comparator: HBsAg quantification>20,000 IU/ml
stop peginterferon alfa 2a if patients reach HBsAg quantification>20,000 Iu/ml at 12w
Drug: Peginterferon alfa-2a
Duration and combination
Other Name: Pegasys

Sham Comparator: HBsAg<=1500IU/ml
extend peginterferon alfa 2a until 48weeks
Drug: Peginterferon alfa-2a
Duration and combination
Other Name: Pegasys

Sham Comparator: HBsAg >1500 <=20,000 IU/ML
add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w
Drug: Peginterferon alfa-2a
Duration and combination
Other Name: Pegasys

Drug: Entecavir
Other Name: Baraclude Tab

Primary Outcome Measures :
  1. HBeAg seroconversion [ Time Frame: 24 weeks post treatment follow up ]

Secondary Outcome Measures :
  1. The changes of HBsAg titer [ Time Frame: baseline and 24weeks post treatment follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01456312

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Contact: Kwansik Lee, professor +82 11 9636 9935

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Korea, Republic of
Shinchon Severance Hospital Recruiting
Seoul, Korea, Republic of, 120742
Contact: Sanghoon Ahn, professor    82-2-2228-1936   
Principal Investigator: Sanhoon Ahn, Professor         
Sponsors and Collaborators
Gangnam Severance Hospital
Roche Pharma AG
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Study Chair: Kwansik Lee, professor Gangnam Severance Hospital

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Responsible Party: Kwan Sik Lee, professor, Gangnam Severance Hospital Identifier: NCT01456312    
Other Study ID Numbers: ML25588
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012
Keywords provided by Kwan Sik Lee, Gangnam Severance Hospital:
Peginterferon alfa 2a
Response Guided Therapy
Chronic Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs