Clinical Trials

MainTitle

Tenofovir in Asian Chronic Hepatitis B Patients

This study has been completed
Sponsor
The University of Hong Kong

Collaborator
Gilead Sciences

Information provided by (Responsible Party)
The University of Hong Kong
ClinicalTrials.gov Identifier
NCT01728935

First received: November 8, 2012
Last updated: December 29, 2014
Last Verified: December 2014
History of Changes
Purpose

Purpose

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.

Condition Intervention
Chronic Hepatitis B

Drug : Tenofovir disoproxil

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Serologic and Virologic Outcomes of Tenofovir in Asian Chronic Hepatitis B Patients With Prior Nucleoside Analogue Exposure

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures

  • Serum HBV DNA levels [ Time Frame: 3 Years ]
Secondary Outcome Measures:
  • Resistance Profile [ Time Frame: 3 Years ]
    Performed using a Line Probe Assay (LiPA)
  • HBsAg levels [ Time Frame: 3 years ]

Enrollment: 141
Study Start Date: April 2008
Study Completion Date: March 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Tenofovir disoproxil
Tenofovir disoproxil 300mg daily
Drug: Tenofovir disoproxil

Tenofovir disoproxil 300mg daily

Other Name: Viread

Detailed Description:

Recent multi-center trials have shown tenofovir disoprovil fumarate (TDF) demonstrating potent antiviral efficacy in both nucleoside-naive and -experienced chronic hepatitis B (CHB) patients. At present, there has been no identifiable amino acid substitutions associated with resistance to TDF.
Since TDF and adefovir (ADV), another licensed drug for CHB, belong to same molecular group, acyclic phosphonate, there had been various studies investigating the efficacy of TDF in ADV-resistant patients. The efficacy of tenofovir in this group of patients is conflicting. While several studies have shown TDF achieving similar viral suppression when compared to CHB patients without ADV-resistance , another study found that patients with the signature ADV mutations of rtA181V/T and /or rtN236T responded suboptimally to TDF. For all published studies, the number of patients with documented genotypic resistance to adefovir is actually small (n = 17-40), and therefore, further studies in this area are required.
Another interesting point to note was the relatively high rate of hepatitis B surface antigen (HBsAg) seroclearance found in patients taking TDF. The cumulative rate of HBsAg seroclearance up in hepatitis B e antigen (HBeAg)-positive was 10% after 4 years . However, the same study did not find any HBeAg-negative patients achieving HBsAg seroclearance. In addition, studies on TDF were mainly performed in Caucasian patients, the majority being genotypes A and D. A preliminary study performed in Asian patients, predominantly genotypes B and C, did not discover any cases of HBsAg seroclearance . Given the majority of the CHB population is found in Asia, further studies are needed to clarify if HBsAg seroclearance by nucleoside / nucleotide analogues is potentially achievable using TDF.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 75 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

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


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

contacts and locations

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01728935

Locations

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

Sponsors and Collaborators

The University of Hong Kong
Gilead Sciences

Investigators

Principal Investigator: Man-Fung Yuen, MD The University of Hong Kong
More Information

More Information


Responsible Party: The University of Hong Kong  
ClinicalTrials.gov Identifier: NCT01728935   History of Changes  
Other Study ID Numbers: TDF-HKU  
  UW 11-241  
Study First Received: November 8, 2012  
Last Updated: December 29, 2014  

Keywords provided by The University of Hong Kong:

HBV
Tenofovir
HBV DNA
HBsAg
Resistance

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Tenofovir

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.