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HBsAg Related Response Guided Therapy (S-RGT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Gangnam Severance Hospital
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Kwan Sik Lee, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT01456312
First received: October 15, 2011
Last updated: October 29, 2012
Last verified: October 2012

October 15, 2011
October 29, 2012
September 2012
February 2016   (final data collection date for primary outcome measure)
HBeAg seroconversion [ Time Frame: 24 weeks post treatment follow up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01456312 on ClinicalTrials.gov Archive Site
The changes of HBsAg titer [ Time Frame: baseline and 24weeks post treatment follow up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HBsAg Related Response Guided Therapy
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:

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

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
  • Drug: Peginterferon alfa-2a
    Duration and combination
    Other Name: Pegasys
  • Drug: Entecavir
    combination
    Other Name: Baraclude Tab
  • Sham Comparator: HBsAg quantification>20,000 IU/ml
    stop peginterferon alfa 2a if patients reach HBsAg quantification>20,000 Iu/ml at 12w
    Intervention: Drug: Peginterferon alfa-2a
  • Sham Comparator: HBsAg<=1500IU/ml
    extend peginterferon alfa 2a until 48weeks
    Intervention: Drug: Peginterferon alfa-2a
  • Sham Comparator: HBsAg >1500 <=20,000 IU/ML
    add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w
    Interventions:
    • Drug: Peginterferon alfa-2a
    • Drug: Entecavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2016
February 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Kwansik Lee, professor +82 11 9636 9935 leeks519@yuhs.ac
Korea, Republic of
 
NCT01456312
ML25588
No
Kwan Sik Lee, Gangnam Severance Hospital
Gangnam Severance Hospital
Roche Pharma AG
Study Chair: Kwansik Lee, professor Gangnam Severance Hospital
Gangnam Severance Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP