Entecavir Plus Adefovir in Lamivudine-Resistant Patients

NCT00986778 | Withdrawn Phase 4

• 1 other identifier: AI463-195
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with HBV DNA < 50 IU/mL at W48

  Week 48

Secondary Outcomes (6)

• The proportion of patient with HBV DNA < 50 IU/mL at W 96

  Week 96

• Mean reduction of HBV DNA at W 48 & 96

  Week 48 and 96

• The proportion of subjects with ALT normalization at W 48 & 96

  Week 48 & Week 96

• The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96

  Week 48 & 96

• Safety

  Week 48 and Week 96

Study Arms (3)

Lamivudine plus Adefovir

ACTIVE COMPARATOR

Drug: Lamivudine; Drug: Adefovir

Entecavir

ACTIVE COMPARATOR

Drug: Entecavir

Entecavir plus Adefovir

EXPERIMENTAL

Drug: Entecavir; Drug: Adefovir

Interventions

Lamivudine DRUG

Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response

Also known as: Heptotin

Lamivudine plus Adefovir

Entecavir DRUG

Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response

Also known as: Baraclude

Entecavir; Entecavir plus Adefovir

Adefovir DRUG

Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response

Also known as: Hepsera

Entecavir plus Adefovir; Lamivudine plus Adefovir

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
• Naïve to nucleoside/nucleotide analogues except for LVD
• HBV DNA \> 17,200 IU/mL
• Compensated liver function
• Serum ALT \<10 × ULN

You may not qualify if:

• Women who are pregnant or breastfeeding
• Evidence of decompensated cirrhosis
• Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Lamivudine; entecavir; adefovir; adefovir dipivoxil

Condition Hierarchy (Ancestors)

Hepatitis B; 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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2014
• Last Updated: September 1, 2015

Record last verified: 2009-12