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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00435825




Registration number
NCT00435825
Ethics application status
Date submitted
15/02/2007
Date registered
16/02/2007
Date last updated
25/06/2013

Titles & IDs
Public title
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
Scientific title
A Randomized, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.
Secondary ID [1] 0 0
WV19432
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - peginterferon alfa-2a [Pegasys]

Experimental: peginterferon alfa-2a 90 µg_24 Weeks - Participants received 90 micrograms (µg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.

Experimental: peginterferon alfa-2a 180 µg_24 Weeks - Participants received 180 µg peginterferon alfa-2a subcutaneous once a week for 24 weeks.

Experimental: peginterferon alfa-2a 90 µg_48 Weeks - Participants received 90 µg peginterferon alfa-2a subcutaneous once a week for 48 weeks.

Experimental: peginterferon alfa-2a 180 µg_48 Weeks - Participants received 180 µg peginterferon alfa-2a subcutaneous once a week for 48 weeks.


Treatment: Drugs: peginterferon alfa-2a [Pegasys]
90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment - Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.
Timepoint [1] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary outcome [1] 0 0
Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 - Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72.
Timepoint [1] 0 0
Week 72
Secondary outcome [2] 0 0
Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment - Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.
Timepoint [2] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary outcome [3] 0 0
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment - HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment.
Timepoint [3] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary outcome [4] 0 0
Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment - Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.
Timepoint [4] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary outcome [5] 0 0
Percentage of Participants With Normal Alanine Aminotransferase (ALT) - Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.
Timepoint [5] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary outcome [6] 0 0
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment - Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of < 20,000 IU/mL (Less than 100,000 copies/mL) is reported.
Timepoint [6] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary outcome [7] 0 0
Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment - Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of < 2,000 IU/mL (Less than 10,000 copies/mL) is reported.
Timepoint [7] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)
Secondary outcome [8] 0 0
Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment - Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.
Timepoint [8] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary outcome [9] 0 0
Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment - Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA <2,000 IU/ml (Less than 10,000 copies/mL).
Timepoint [9] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary outcome [10] 0 0
Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment - Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).
Timepoint [10] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Secondary outcome [11] 0 0
Quantitative HBV-DNA 24 Weeks Following End of Treatment - Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.
Timepoint [11] 0 0
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;

- positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA
>500,000 copies/mL, and anti-HBs negative;

- liver disease consistent with Chronic Hepatitis B.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- antiviral therapy for CHB within previous 6 months;

- co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus
(HDV) or Human immuno deficiency virus (HIV);

- evidence of decompensated liver disease;

- medical condition associated with chronic liver disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Fitzroy
Recruitment hospital [2] 0 0
- Greenslopes
Recruitment hospital [3] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Brazil
State/province [7] 0 0
Campinas
Country [8] 0 0
Brazil
State/province [8] 0 0
Ribeirão Preto
Country [9] 0 0
Brazil
State/province [9] 0 0
Salvador
Country [10] 0 0
Brazil
State/province [10] 0 0
Santo Andre
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Guangzhou
Country [14] 0 0
China
State/province [14] 0 0
Hunan
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
France
State/province [16] 0 0
Clichy
Country [17] 0 0
France
State/province [17] 0 0
Montpellier
Country [18] 0 0
France
State/province [18] 0 0
Nice
Country [19] 0 0
France
State/province [19] 0 0
Strasbourg
Country [20] 0 0
France
State/province [20] 0 0
Toulouse
Country [21] 0 0
France
State/province [21] 0 0
Villejuif
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Frankfurt Am Main
Country [24] 0 0
Germany
State/province [24] 0 0
Freiburg
Country [25] 0 0
Germany
State/province [25] 0 0
Hannover
Country [26] 0 0
Germany
State/province [26] 0 0
Köln
Country [27] 0 0
Hong Kong
State/province [27] 0 0
Hong Kong
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland
Country [30] 0 0
New Zealand
State/province [30] 0 0
Hamilton
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Samara
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Smolensk
Country [33] 0 0
Russian Federation
State/province [33] 0 0
St Petersburg
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Stavropol
Country [35] 0 0
Singapore
State/province [35] 0 0
Singapore
Country [36] 0 0
Taiwan
State/province [36] 0 0
Kaohsiung
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taoyuan
Country [39] 0 0
Thailand
State/province [39] 0 0
Bangkok
Country [40] 0 0
Thailand
State/province [40] 0 0
Chiang Mai
Country [41] 0 0
Thailand
State/province [41] 0 0
Khon Kaen
Country [42] 0 0
Thailand
State/province [42] 0 0
Songkhla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks,
and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with
chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90
micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24
weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly
for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up
in all treatment groups for the primary endpoint. The anticipated time on study treatment is
3-12 months, and the target sample size is 500+ individuals.
Trial website
https://clinicaltrials.gov/show/NCT00435825
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications