Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B (EVD)

University of Ulm

Status and phase: Withdrawn; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Telbivudine; Drug: Lamivudine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00710216

EVD-001

Details and patient eligibility

About

This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented compensated HBeAg-positive or negative chronic hepatitis B
• Increased viral load with a concentration of serum HBV-DNA of at least 10^4 copies/ml
• Proof of inflammatory activity in the liver: ALT ≥ 2 x ULN or histological evidence of inflammatory activity ≥ level I or fibrosis of ≥ I degrees (according to the Desmet classification)
• Negative urine pregnancy test with fertile women
• Willingness to use a recognized method of contraception
• Able to comply with study regimen and provide written informed consent

Exclusion criteria

• Current or previous antiviral treatment of chronic hepatitis B with Nucleus(t)id analoga
• Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations
• Pregnant or breastfeeding women or women
• Simultaneous participation in other clinical trials or in the past three months
• Co-infected with HCV, HDV, HIV
• Other non HBV-related chronic liver disease: Autoimmune hepatitis, primary biliary cirrhosis, Hemochromatosis, alpha-1 antitrypsin deficiency, alcoholic hepatitis
• Evidence of hepatocellular carcinoma (alpha-fetoprotein levels> 100 ng/ml)
• Active drug use, including an excessive alcohol consumption during the last 6 months before participating in the clinical trial
• Use of systemic treatment with anti-neoplastic or immunomodulatory medication within the last 6 months before participating in the clinical trial and during the duration of the clinical examination
• Lack of willingness or inability to consent in writing
• Concurrent condition likely to preclude compliance with schedule of evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Lamivudine

B

Experimental group

Treatment:

Drug: Telbivudine