Phase 3
Completed N=34
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT01475851 ↗
Enrolled (actual)
34
Serious AEs
8.8%
Results posted
Nov 2013
Primary outcomePrimary: Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24 — 8; 12 participants
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 drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24 |
8; 12 | — |
| SECONDARY Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96 |
-2.72; -3.33; -2.88; -3.50; -3.02; -3.50 | — |
| SECONDARY Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96 |
9; 12; 10; 14 | — |
| SECONDARY Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 |
3; 6; 3; 5; 3; 6 | — |
| SECONDARY Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 |
0; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Virological Breakthrough and Resistance-related Mutations |
0; 1; 11; 17; 4; 0 | — |
| SECONDARY Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 |
0; 0; 1; 0; 6; 12 | — |
| SECONDARY Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96 |
0; 0; 0; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 = 4 log10 copies/mL, Chronic hepatitis B with cirrhosis ; HBV NDA >= 3 log10 copies/mL
- Serum ALT = 70 mL/min
- Haemoglobin >= 8 g/dL
- WBC >= 1,000 /mm3
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01475851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.