Tenofovir in Asian Chronic Hepatitis B Patients

NCT01728935 | Completed

• 2 other identifiers: TDF-HKUUW 11-241
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Tenofovir (TDF) has been demonstrated to have potency antiviral against the hepatitis B virus (HBV) in various multiple-centre trials, with no cases of resistance encountered. However, its efficacy and resistance profile in the Asian population, which constitute the majority of chronic hepatitis B (CHB) patients, is unknown. Compared to other nucleoside analogues, TDF has been associated with relatively high rates of hepatitis B surface antigen (HBsAg) seroclearance. It would be interested to see if this could be reproduced. The investigators plan to report the serologic and virologic results of our 140 nucleoside analogue-experienced patients who were commenced on TDF.

Conditions

Chronic Hepatitis B

Keywords

HBV; Tenofovir; HBV DNA; HBsAg; Resistance

Outcome Measures

Primary Outcomes (1)

• Serum HBV DNA levels

  3 Years

Secondary Outcomes (2)

• Resistance Profile

  3 Years

• HBsAg levels

  3 years

Study Arms (1)

Tenofovir disoproxil

OTHER

Tenofovir disoproxil 300mg daily

Drug: Tenofovir disoproxil

Interventions

Tenofovir disoproxil DRUG

Tenofovir disoproxil 300mg daily

Also known as: Viread

Tenofovir disoproxil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HBsAg-positivity for at least 6 months at presentation
• Commenced on tenofovir for chronic hepatitis B
• Exposure to other nucleoside analogues before starting TDF

You may not qualify if:

• Concomitant liver diseases including chronic hepatitis C and/ or D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
• Significant alcohol intake (\> 20 grams per day)

Sponsors & Collaborators

• The University of Hong Kong: lead
• Gilead Sciences: collaborator

Study Sites (1)

Department of Medicine, The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

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

Study Officials

• Man-Fung Yuen, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 20, 2012
• Study Start: April 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

HK (1)