Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients

NCT01491295 | Unknown Phase 4

• 1 other identifier: IN-US-174-0194
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Adefovir add-on therapy is superior to switching to adefovir monotherapy or entecavir 1mg monotherapy for chronic hepatitis B (CHB) patients with lamivudine resistance (LAM-R)
2. 2.Long-term adefovir add-on therapy was effective for viral suppression. However, the economic burden for such dual antiviral therapy is heavy because of infinite treatment.
3. 3.Tenofovir disoproxil fumarate (TDF) is a potent antiviral agent. TDF demonstrated potent antiviral efficacy in a subset of lamivudine experienced HBeAg-positive patients. TDF is also superior to ADV in HBeAg-negative and HBeAg-positive treatment-naive patients.
4. 4.Theoretically, TDF can replace LAM/ADV when viral suppression has been achieved by LAM/ADV combination treatment in LAM-R CHB patients.

Conditions

Chronic Hepatitis B

Keywords

Lamivudine; adefovir add on treatment; tenofovir; chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

• Incidence of virological breakthrough (defined as HBV DNA > 100 IU/ml)

  Sustained viral suppression after switching to TDF for 36 months

Secondary Outcomes (2)

• HBeAg seroconversion (for HBeAg-positive patients)

  HBeAg seroconversion rate at 1, 2 and 3 years

• Incidence of HBsAg loss

  Incidence of HBsAg loss at 1-, 2-, and 3 -years

Study Arms (2)

Lamivudine plus adefovir

ACTIVE COMPARATOR

Continue lamivudine/adefovir add on treatment (standard treatment)

Drug: Lamivudine plus adefovir

Tenofovir

EXPERIMENTAL

Switch from lamivudine/adefovir add on threatment to tenofovir monotherapy

Drug: Tenofovir disoproxil fumarate

Interventions

Tenofovir disoproxil fumarate DRUG

Tenofovir disoproxil fumarate 300mg QD for 36 months (adjust dosage according to renal function)

Also known as: Viread

Tenofovir

Lamivudine plus adefovir DRUG

Lamivudine 100mg QD for 36 months (adjust dosage according to renal function) Adefovir 10mg QD for 36 months (adjust dosage according to renal function)

Also known as: Zeffix, Hepsera

Lamivudine plus adefovir

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HBsAg-positive for more than 6 months (HBeAg-positive or HBeAg-negative).
• Age \> 20 y/o.
• Under lamivudine/adefovir treatment for more than 1 year due to previous lamivudine resistance (LAM-R), current HBV DNA is undetectable (\< 20 IU/ml) during enrollment.

You may not qualify if:

• HCV, HIV, HDV coinfection.
• Uncontrolled HCC, malignancy or decompensated liver cirrhosis (CTP score ≥ 7).
• Uremia patients or Creatinine ≥ 2 mg/dl.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• China Medical University Hospital: collaborator
• Chi Mei Medical Hospital: collaborator
• Chiayi Christian Hospital: collaborator

Study Sites (1)

Taipei Veterans General Hospital-Division of Gastroenterology

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir; Lamivudine; 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)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Yi-Hsiang Huang

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Hsiang Huang, MD, PhD

CONTACT

886-2-28712121; yhhuang@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Yi-Hsiang Huang

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: December 13, 2011
• Study Start: September 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

TW (1)