Clinical Trials Logo
  1. Home
  2. Chronic Hepatitis B
  3. NCT00057265
  4. Details
NCT00057265 Clinical Trial

A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00057265
Other study ID # NV-02B-007
Secondary ID
Status Completed
Phase Phase 3
First received March 28, 2003
Last updated March 19, 2015
Start date February 2003

Study information
Verified date March 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date April 2006
Accepts healthy volunteers
Gender Both
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria:

- Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Patient is pregnant or breastfeeding

- Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2.

- Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time

- Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study

Other protocol defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• telbivudine or lamivudine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Spain,  Thailand,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.
Secondary Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.
See also
  Status Clinical Trial Phase
Recruiting NCT04496882 - Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue Phase 4
Completed NCT04083716 - A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults Phase 1
Not yet recruiting NCT03038802 - A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection Phase 1/Phase 2
Completed NCT05310487 - Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects Phase 1
Recruiting NCT06070051 - Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy Phase 1
Terminated NCT05001022 - A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects Phase 1
Recruiting NCT04139850 - The Establishment of Korean Hepatitis B Patients Cohort
Recruiting NCT05343481 - Efficacy of VTP-300 in Chronic Hepatitis B Infection Phase 2
Not yet recruiting NCT05490836 - Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients N/A
Recruiting NCT04543565 - Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study Phase 3
Active, not recruiting NCT02894918 - A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs Phase 4
Not yet recruiting NCT02793791 - Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients N/A
Recruiting NCT02287857 - Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B N/A
Recruiting NCT01965418 - A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial Phase 4
Recruiting NCT01491295 - Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients Phase 4
Terminated NCT01872988 - Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma Phase 3
Recruiting NCT01487876 - Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients Phase 2
Completed NCT01531166 - A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon N/A
Not yet recruiting NCT01436539 - Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients Phase 4
Recruiting NCT01360879 - Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease N/A

External Links