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Trial registered on ANZCTR


Registration number
ACTRN12606000381583
Ethics application status
Approved
Date submitted
28/08/2006
Date registered
29/08/2006
Date last updated
29/08/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open-Label Study Evaluating the Antiviral Activity of Tenofovir Disoproxil Fumarate (DF) 300mg in Patients with Chronic Hepatitis B Infection and Persistent Viral Replication after Long-Term Therapy with Adefovir Dipivoxil 10mg Daily
Scientific title
An Open-Label Study Evaluating the Antiviral Activity of Tenofovir Disoproxil Fumarate (DF) 300mg in Patients with Chronic Hepatitis B Infection and Persistent Viral Replication after Long-Term Therapy with Adefovir Dipivoxil 10mg Daily
Universal Trial Number (UTN)
Trial acronym
109
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 1347 0
Condition category
Condition code
Inflammatory and Immune System 1437 1437 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment for patients who are no longer responding to current, registered treatments (lamivudine 100 mgs daily and adefovir 10 mgs daily)
The drug is tenofovir, at 300 mgs orally daily. Treatment is given indefinitely.
Intervention code [1] 1331 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1974 0
To evaluate the antiviral activity of tenofovir 300 mgs
Timepoint [1] 1974 0
At week 12
Secondary outcome [1] 3439 0
To evaluate the safety and efficacy of tenofovir Disoproxil Fumarate (DF) 300mg daily.
Timepoint [1] 3439 0
At Week 48 and every 48 weeks thereafter to end of study (week 144).
Secondary outcome [2] 3440 0
To assess the efficacy of tenofovir DF 300mg in patients with confirmed adefovir dipivoxil resistance (N236T and / or A181V-these are particular areas of the hepatitis B genome ).
Timepoint [2] 3440 0
Secondary outcome [3] 3441 0
Evaluate the incidence of tenofovir Disoproxil Fumarate (TDF) resistant mutations.
Timepoint [3] 3441 0
At Week 48 and at end of every 48 weeks therafter until end of study (Week 144).
Secondary outcome [4] 3442 0
To evaluate the activity of combination therapy (tenofovir DF 300mg + lamivudine 100mg) in patients with with persistent viral replication following switch to tenofovir DF 300mg (defined as hepatitis B virus deoxyribonucleic acid (HBV DNA) ³400 copies/mL confirmed on 2 consecutive visits following at least 24 weeks treatment with tenofovir DF 300mg).
Timepoint [4] 3442 0

Eligibility
Key inclusion criteria
Male and non-pregnant/non-lactating female HBV infected patients. Patients who are currently receiving adefovir dipivoxil 10 mg daily in combination with lamivudine will be eligible for enrollment. Inclusion criteria include:·Chronic hepatitis B infection defined by positive serum hepatitis B surface antigen (HBsAg) for at least 6 months· Failed lamivudine therapy;· Active chronic hepatitis B infection:o hepatitis B E antigen (HBeAg) negative OR HBeAg positiveo Serum HBV DNA greater or equal to 105 (HBeAg positive) or 104 (HBeAg negative) copies/ml at screening while receiving continuous therapy with adefovir dipivoxil 10mg daily for at least 24 weeks.· Written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Female who is pregnant or breastfeeding;· Female of childbearing potential who is unwilling to use effective contraception method while enrolled in the study;· Decompensated liver disease defined as bilirubin > 1.5 times the upper limit of normal (ULN), prothrombin time (PT) > 1.5 times the ULN, platelets < 75,000/mm3, serum albumin < 30g/l or prior history of clinical hepatic decompensation;· Evidence of hepatocellular carcinoma (alpha-fetoprotein > 50mg/l);· Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV);· Significant renal cardiovascular, pulmonary or neurological disease;· The following laboratory values obtained within 30 days prior to study entry:o Creatinine clearance < 70 ml/mino haemoglobin (Hb) < 8g/dlo Leukocytes < 1000mm3.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1568 0
Commercial sector/Industry
Name [1] 1568 0
Gilead
Country [1] 1568 0
Funding source category [2] 1569 0
Hospital
Name [2] 1569 0
Austin Health
Country [2] 1569 0
Australia
Funding source category [3] 1570 0
Hospital
Name [3] 1570 0
Monash Medical Centrre
Country [3] 1570 0
Australia
Funding source category [4] 1571 0
Hospital
Name [4] 1571 0
The Alfred
Country [4] 1571 0
Australia
Funding source category [5] 1572 0
Hospital
Name [5] 1572 0
St Vincent's
Country [5] 1572 0
Australia
Funding source category [6] 1573 0
Hospital
Name [6] 1573 0
Royal Melbourne
Country [6] 1573 0
Australia
Funding source category [7] 1574 0
Hospital
Name [7] 1574 0
The Western hospital
Country [7] 1574 0
Australia
Funding source category [8] 1575 0
Hospital
Name [8] 1575 0
RPA
Country [8] 1575 0
Australia
Primary sponsor type
Hospital
Name
Austin Health (investigator initiated)
Address
Country
Australia
Secondary sponsor category [1] 1383 0
Commercial sector/Industry
Name [1] 1383 0
Gilead is a supporter of the study as they are supplying free drug
Address [1] 1383 0
Country [1] 1383 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3001 0
Austin Health
Ethics committee address [1] 3001 0
Ethics committee country [1] 3001 0
Australia
Date submitted for ethics approval [1] 3001 0
Approval date [1] 3001 0
28/07/2006
Ethics approval number [1] 3001 0
H2006/02552

Summary
Brief summary
The purpose of the protocol is to provide people who not responding to current hepatitis B treatments another option.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27938 0
Address 27938 0
Country 27938 0
Phone 27938 0
Fax 27938 0
Email 27938 0
Contact person for public queries
Name 10520 0
Professor Peter Angus
Address 10520 0
LTU, Austin Health, Studley Rd,
Heidelberg. VIC 3084
Country 10520 0
Australia
Phone 10520 0
03 9496 5582
Fax 10520 0
03 9496 2732
Email 10520 0
peter.angus@austin.org.au
Contact person for scientific queries
Name 1448 0
Professor Peter Angus
Address 1448 0
LTU, Austin Health, Studley Rd,
Heidelberg. 3084
Country 1448 0
Australia
Phone 1448 0
03 9496 5582
Fax 1448 0
03 9496 2732
Email 1448 0
peter.angus@austin.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.