Phase 3
Completed N=65
Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT00395018 ↗
Enrolled (actual)
65
Serious AEs
55.4%
Results posted
May 2012
Primary outcomePrimary: Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72 — 0 percentage of participants
Summary
The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72 |
— | — |
| PRIMARY Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72 |
3; 0; 0; 0; 0; 0 | — |
| SECONDARY Distribution of ALT Levels Through 72 Weeks: Overall |
158.7; 61.2; 28.4; 28.4; 41.2; 24.9 | — |
| SECONDARY Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up |
— | — |
| SECONDARY Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants) |
100 | — |
| SECONDARY Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants) |
— | — |
| SECONDARY Percentage of Participants With HBsAg Loss at Week 72 |
96.7 | — |
| SECONDARY Percentage of Participants With HBsAg Seroconversion at Week 72 |
80.3 | — |
| SECONDARY Percentage of Participants With HBsAg Recurrence At Week 72 |
3.3 | — |
| SECONDARY Total Bilirubin at Week 72 |
0.79 | — |
| SECONDARY Prothrombin Time (PT) at Week 72 |
13.32 | — |
| SECONDARY Number of Participants With Liver Rejection Through Week 72 |
18 | — |
| SECONDARY Number of Participants With Re-transplantation Through Week 72 |
3 | — |
| SECONDARY Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF]) |
4; 36; 0; 0; 62; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades) |
56; 1; 50; 2; 24; 1 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades) |
54; 0; 56; 0; 34; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA < 172 IU/mL (approximately < 1000 copies/mL) prior to liver transplant
- Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening
Exclusion Criteria
- Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm
- Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV)
Data sourced from ClinicalTrials.gov (NCT00395018). 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.