Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine

NCT01005238 | Terminated Phase 4 DMC

• 1 other identifier: SASL28
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.

Conditions

Hepatitis, Chronic

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the rate of viral breakthrough during treatment defined as an increase of the viral titer to > 200 IU/mL.

  The primary efficacy endpoint is the rate of viral breakthrough at week 108.

Study Arms (2)

telbivudine

ACTIVE COMPARATOR

patients in this arm will continue to take telbivudine

Drug: Telbivudine

lamivudine

EXPERIMENTAL

patients in this arm will take lamivudine

Drug: Lamivudine

Interventions

Lamivudine DRUG

lamivudine

Telbivudine DRUG

telbivudine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, \> 18 (having completed their 18th birthday). There is no upper limit of age
• Documented HBeAg negative CHB
• HBsAg positive \> 6 months
• HBV DNA \> 2000 IU/mL
• Patient is willing and able to comply with the study drug regimen and all other study requirements.
• Written informed consent
• Anti-viral HBV treatment naïve or previous treatment with interferon-alpha or pegylated interferon-alpha stopped at least 1 month prior to screening

You may not qualify if:

• Decompensated liver cirrhosis according to the judgment of the local investigator
• Hepatocellular carcinoma
• History of or laboratory signs of co-infection with HIV or HCV, HDV
• History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients
• Any medical condition that requires frequent or prolonged use of systemic corticosteroids (inhaled, topic or intra-articular corticosteroids are allowed)
• Any medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
• Current abuse of alcohol or illicit drugs.
• Use of other investigational drugs at the time of randomization, or within 30 days or 5 half-lives of enrollment, whichever is longer.
• Any other concurrent medical or social condition which is, in the opinion of the investigator, likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
• Any of the following laboratory values during Screening:
• Hemoglobin (HGB) \<11 g/dL for men or \<10 g/dL for women
• Total WBC \<3000/mm3
• Absolute neutrophil count (ANC) \<1,500.mm3
• Platelet count \<50'000/mm3
• Serum amylase or lipase ≥ 1.5 x ULN

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Hepatitis, Chronic

Interventions

Lamivudine; Telbivudine

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Officials

• Markus Heim, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2014
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

CH (1)