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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00927082




Registration number
NCT00927082
Ethics application status
Date submitted
16/06/2009
Date registered
24/06/2009
Date last updated
9/03/2016

Titles & IDs
Public title
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
Scientific title
A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).
Secondary ID [1] 0 0
MV22430
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: PEG-IFN 90mcg 24 Wks - Participants received Pegasys (Pegylated interferon alfa-2a \[PEG-IFN\]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.

Experimental: PEG-IFN 180mcg 24 Wks - Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.

Experimental: PEG-IFN 90mcg 48 Wks - Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.

Experimental: PEG-IFN 180mcg 48 Wks - Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.


Treatment: Drugs: peginterferon alfa-2a [Pegasys]
90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
Timepoint [1] 0 0
Annually, for up to 5 years
Primary outcome [2] 0 0
Percentage of Participants With HBsAg Loss
Timepoint [2] 0 0
Annually, for up to 5 years
Secondary outcome [1] 0 0
Percentage of Participants With HBeAg Loss.
Timepoint [1] 0 0
Annually, for up to 5 years
Secondary outcome [2] 0 0
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
Timepoint [2] 0 0
Annually, for up to 5 years
Secondary outcome [3] 0 0
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
Timepoint [3] 0 0
Annually, for up to 5 years
Secondary outcome [4] 0 0
Percentage of Participants With Presence of Anti-HBs
Timepoint [4] 0 0
Annually, for up to 5 years
Secondary outcome [5] 0 0
Percentage of Participants With Normalised Alanine Transaminase (ALT)
Timepoint [5] 0 0
Annually, for up to 5 years
Secondary outcome [6] 0 0
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
Timepoint [6] 0 0
Annually, for up to 5 years
Secondary outcome [7] 0 0
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
Timepoint [7] 0 0
Annually, for up to 5 years
Secondary outcome [8] 0 0
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
Timepoint [8] 0 0
Annually, for up to 5 years
Secondary outcome [9] 0 0
Quantitative HBsAg
Timepoint [9] 0 0
Annually, for up to 5 years
Secondary outcome [10] 0 0
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Timepoint [10] 0 0
Up to 5-year FU period
Secondary outcome [11] 0 0
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Timepoint [11] 0 0
Up to 5-year FU period
Secondary outcome [12] 0 0
Number of Participants With Marked Laboratory Abnormalities
Timepoint [12] 0 0
Up to 5-year FU period

Eligibility
Key inclusion criteria
* Informed consent for Study WV19432
* Patients who have completed treatment and follow-up on study WV19432
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* As for Study WV19432

Study design
Purpose of the study
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
Open (masking not used)
Who is / are masked / blinded?



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
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
383
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
BA
Country [2] 0 0
Brazil
State/province [2] 0 0
SP
Country [3] 0 0
China
State/province [3] 0 0
Beijing
Country [4] 0 0
China
State/province [4] 0 0
Changsha
Country [5] 0 0
China
State/province [5] 0 0
Guangzhou
Country [6] 0 0
China
State/province [6] 0 0
Shanghai
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Hong Kong
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Hamilton
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Samara
Country [12] 0 0
Russian Federation
State/province [12] 0 0
St Petersburg
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Stavropol
Country [14] 0 0
Singapore
State/province [14] 0 0
Singapore
Country [15] 0 0
Taiwan
State/province [15] 0 0
Kaohsiung
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taipei
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taoyuan
Country [18] 0 0
Thailand
State/province [18] 0 0
Bangkok
Country [19] 0 0
Thailand
State/province [19] 0 0
Chiang Mai
Country [20] 0 0
Thailand
State/province [20] 0 0
Khon Kaen
Country [21] 0 0
Thailand
State/province [21] 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 study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00927082
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00927082