To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)

NCT00537537 | Completed Phase 4

• 1 other identifier: CLDT600AIN01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

This study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Antiviral efficacy is assessed by hepatitis B virus (HBV) DNA non-detectability (PCR \<300 copies/ml) by week 104 with CHB.

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B, Chronic, Hepatitis B e Antigen positive, Adults, Telbivudine, Adefovir

Outcome Measures

Primary Outcomes (1)

• Antiviral efficacy with adefovir combination assessed by HBV DNA non-detectability (PCR <300 copies/ml) by week 104.

Secondary Outcomes (5)

• Antiviral efficacy with telbivudine alone assessed by HBV DNA non-detectability (PCR <300 copies/ml) at week 24 and 36.

• HBeAg loss & HBeAg seroconversion (defined as a loss of HBeAg and a gain of detectable level of HBeAb).

• Alanine Transaminase (ALT) normalization, in patients with raised levels at baseline.

• Change in HBV DNA level (log10 copies/ml) from baseline to week 4, 8, 12, 24, 36, 52, 76 and 104.

• Viral breakthrough, defined as increase of HBV DNA by 1 log10 copies/ml from treatment nadir, at any point after week 24.

Study Arms (3)

1

ACTIVE COMPARATOR

Telbivudine

Drug: Telbivudine

2

ACTIVE COMPARATOR

Telbivudine

Drug: Telbivudine

3

ACTIVE COMPARATOR

Telbivudine

Drug: Telbivudine

Interventions

Telbivudine DRUG

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigative Site

Hyderabad, India

Location

Novartis Investigative Site

Mumbai, India

Location

Novartis Investigative Site

Vellore, India

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B; Bronchiolitis Obliterans Syndrome

Interventions

Telbivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2011
• Last Updated: June 23, 2017

Record last verified: 2016-04

Locations

IN (3)