HBsAg Related Response Guided Therapy (S-RGT)
This study is currently recruiting participants.
Verified October 2012 by Gangnam Severance Hospital
Sponsor:
Gangnam Severance Hospital
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
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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:
- 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)
Contacts and Locations
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, Chronic 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 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 May 23, 2013