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Entecavir for Fibrosis Regression in Chronic Hepatitis B
NCT01341106Phase 4
Key facts
- Status
- Terminated
- Start
- Apr 2011
- Primary completion
- Jan 2015
- Countries
- 1
- Sponsor
- RWTH Aachen University
- Modality
- Small Molecules
- Drugs
- entecavir
- Conditions
- hepatitis B (HBV)
01
Overview
Phase 4, open-label, single-arm trial of entecavir in hepatitis B (HBV), sponsored by RWTH Aachen University. Primary endpoints: Changes of liver stiffness measurement (LSM) at 12 months and Changes of hyaluronan measurement in blood at 12 months. Started Apr 2011; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment Arm
Patients treated with entecavir daily.
03
Who it enrols
Patients with chronic hepatitis B infection, detectable HBV-DNA, and relevant liver fibrosis (>= F2) on biopsy. Patients must not have been treated with lamivudine or telbivudine previously.
04
Endpoints
Primary
Changes of liver stiffness measurement (LSM)
Changes of hyaluronan measurement in blood
Secondary
Changes on Pro-Collagen-III-N-Peptid, Tissue Inhibitor of Metalloproteinases (TIMP-1) and Chitinase-3-like protein 1(YKL-40) in serum
Sensitivity and specificity of non-invasive marker at the baseline in comparison to liver biopsy as a gold standard
Changes on FibroScan-measurement (LSM) and serum parameter
Decrease of hepatitis B virus-DNA and quota of patients with non-detectable hepatitis B virus-DNA
Quota of patients with normalization of Alanine transaminase(ALT)-measurement in blood
Quota of patients with hepatitis B viral protein loss, antibodies to the the hepatitis B 'e' antigen seroconversion, surface antigen of the Hepatitis-B-Virus loss and antibodies to the hepatitis B…
Incidence of side effects
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