Status:
COMPLETED
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
16-69 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other dru...
Detailed Description
This is a multicenter, open-label study in Japanese patients with compensated chronic hepatitis B with poor response to other drugs in order to evaluate the efficacy and safety of GSK548470 administer...
Eligibility Criteria
Inclusion
- The ability to understand and sign a written informed consent form
- 16 to 69 years of age at the time of informed consent
- Females of childbearing potential must have a negative pregnancy test and agree to avoidance of pregnancy
- Subject must show QTc \<450 millisecond (msec) or \<480msec with Bundle Branch Block
- Chronic HBV infection, defined as positive serum HBsAg for at least 6 month
- Subjects currently treated with LAM/ADV, ETV or ETV/ADV for greater than 24 weeks
- Chronic hepatitis B ; HBV NDA \>= 4 log10 copies/mL, Chronic hepatitis B with cirrhosis ; HBV NDA \>= 3 log10 copies/mL
- Serum ALT \<= 10 × ULN
- Creatinine clearance \>= 70 mL/min
- Haemoglobin \>= 8 g/dL
- WBC \>= 1,000 /mm3
Exclusion
- Decompensated liver disease
- Co-infection with HIV or HCV
- Autoimmune hepatitis rather than chronic hepatitis B
- Subject with serious complication
- Received or have a plan for solid organ or bone marrow transplantation
- Has proximal tubulopathy
- History of hypersensitivity to nucleoside and/or nucleotide analogues
- Evidence of hepatocellular carcinoma by diagnostic imaging at screening and/or serum α-fetoprotein \> 50 ng/mL at screening
- History of HCC
- Received any interferon or HB vaccine therapy within 24 weeks prior to initiation
- Received overdose NSAIDs, excluding temporary or topical use, within 7 days prior to initiation
- Received drugs for injection containing glycyrrhizin as the main component within 4 weeks prior to initiation
- Received drugs causing renal impairment, competitors of renal excretion, immunosuppressants, chemotherapeutics and/or corticosteroids within 8 weeks prior to initiation
- Participation in another clinical study within 6 months of study entry or planned participation in another clinical study after entry to this study
- Woman who is pregnant, lactating, possibly pregnant or planning a pregnancy during the study period
- Psychiatry disorder or cognitive disorder that may affect the subject ability to give informed consent or to follow specified study procedures
- History of alcohol or drug abuse
- Any condition or situation that may interfere with the subject's participation in the study
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01475851
Start Date
December 1 2011
End Date
October 1 2014
Last Update
June 22 2015
Active Locations (11)
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1
GSK Investigational Site
Aichi, Japan, 466-8560
2
GSK Investigational Site
Aichi, Japan, 467-8602
3
GSK Investigational Site
Chiba, Japan, 260-8677
4
GSK Investigational Site
Fukuoka, Japan, 803-8505