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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
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
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)
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
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
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
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
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
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
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
Sex
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
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
551
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
Trial website
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00435825