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
  Purpose

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 Intervention Phase
Hepatitis B, Chronic
Drug: Peginterferon alfa-2a
Drug: Entecavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Resource links provided by NLM:


Further study details as provided by Gangnam Severance Hospital:

Primary Outcome Measures:
  • HBeAg seroconversion [ Time Frame: 24 weeks post treatment follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The changes of HBsAg titer [ Time Frame: baseline and 24weeks post treatment follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
combination
Other Name: Baraclude Tab

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456312

Contacts
Contact: Kwansik Lee, professor +82 11 9636 9935 leeks519@yuhs.ac

Locations
Korea, Republic of
Shinchon Severance Hospital Recruiting
Seoul, Korea, Republic of, 120742
Contact: Sanghoon Ahn, professor    82-2-2228-1936    ahnsh@yuhs.ac   
Principal Investigator: Sanhoon Ahn, Professor         
Sponsors and Collaborators
Gangnam Severance Hospital
Roche Pharma AG
Investigators
Study Chair: Kwansik Lee, professor Gangnam Severance Hospital
  More Information

No publications provided

Responsible Party: Kwan Sik Lee, professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT01456312     History of Changes
Other Study ID Numbers: ML25588
Study First Received: October 15, 2011
Last Updated: October 29, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Gangnam Severance Hospital:
Peginterferon alfa 2a
Entecavir
Response Guided Therapy
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014