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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01011738




Registration number
NCT01011738
Ethics application status
Date submitted
10/11/2009
Date registered
11/11/2009
Date last updated
10/04/2017

Titles & IDs
Public title
An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys
Scientific title
A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating On-Treatment Predictors of Response in Subjects With HBeAg Positive and HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS(R) (Peginterferon Alfa-2a 40KD)
Secondary ID [1] 0 0
MV22009
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cohort -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance
Timepoint [1] 0 0
Up to 276 Weeks
Primary outcome [2] 0 0
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants
Timepoint [2] 0 0
Up to 276 Weeks
Primary outcome [3] 0 0
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants
Timepoint [3] 0 0
Up to 276 Weeks
Secondary outcome [1] 0 0
Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter
Timepoint [1] 0 0
Up to 276 Weeks
Secondary outcome [2] 0 0
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants
Timepoint [2] 0 0
Up to 276 Weeks
Secondary outcome [3] 0 0
Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants
Timepoint [3] 0 0
Up to 276 Weeks
Secondary outcome [4] 0 0
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid <2000IU/mL in Hepatitis B Virus e Antigen Positive Participants
Timepoint [4] 0 0
Up to 276 Weeks
Secondary outcome [5] 0 0
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion
Timepoint [5] 0 0
Up to 276 Weeks
Secondary outcome [6] 0 0
Quantitative Hepatitis B Surface Antigen
Timepoint [6] 0 0
Up to 276 Weeks
Secondary outcome [7] 0 0
Percentage of Participants With Normalization of Alanine Transaminase
Timepoint [7] 0 0
Up to 276 Weeks
Secondary outcome [8] 0 0
Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status
Timepoint [8] 0 0
Up to 276 Weeks
Secondary outcome [9] 0 0
Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation
Timepoint [9] 0 0
Up to 276 Weeks
Secondary outcome [10] 0 0
Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis
Timepoint [10] 0 0
Up to 276 Weeks
Secondary outcome [11] 0 0
Number of Participants With Serious Adverse Drug Reactions
Timepoint [11] 0 0
Up to 276 Weeks
Secondary outcome [12] 0 0
Number of Participants With Non-Serious Adverse Drug Reactions
Timepoint [12] 0 0
Up to 276 Weeks
Secondary outcome [13] 0 0
Number of Participants With Adverse Events and Serious Adverse Events
Timepoint [13] 0 0
Up to 276 Weeks
Secondary outcome [14] 0 0
Number of Deaths During Observation Period
Timepoint [14] 0 0
Up to 276 Weeks

Eligibility
Key inclusion criteria
* adult patient, >/= 18 years of age
* chronic hepatitis B
* treatment with peginterferon alfa-2A
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* coinfection with HAV, HCV and HIV

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/11/2014
Sample size
Target
Accrual to date
Final
1842
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Wien
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Bahrain
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Manama
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Bangladesh
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Dhaka
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Bosnia and Herzegovina
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Banja Luka
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Bihac
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Bosnia and Herzegovina
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Mostar
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Sarajevo
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Tuzla
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Varna
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ShenYang
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Shi Jiazhuang
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Urumqi
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Rawalpindi
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Wroclaw
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Portugal
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Porto
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Romania
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.
Trial website
https://clinicaltrials.gov/study/NCT01011738
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/NCT01011738