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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01011738
Ethics application status
Date submitted
10/11/2009
Date registered
10/11/2009
Date last updated
10/03/2017

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 - Percentage of participants who became Hepatitis B Virus Surface Antigen (HBsAg) negative by the end of the observation period. A participant was considered to have achieved HBsAg clearance if the HBsAg measurement was reported as: (a) 'Negative' or (b) a quantitative result lower than the reported lower limit of detection. An observational period was upto 3 years post-treatment. The analysis was performed by 2 methods: Analysis A and Analysis B. For analysis A, all participants included in the analyzed population were used (participants with missing measurement for calculation of the endpoint were considered non-responders regarding the endpoint). For analysis B method, only participants in the analyzed population without missing measurements for calculation of the endpoint were used (analysis "as observed").
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 - The probability that the participant who develops an early virological/serological response would achieve Hepatitis B Surface Antigen (HBsAg) clearance 3 years post-treatment is called the positive predictive value (PPV) of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the negative predictive value (NPV) of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg positive participant, HBsAg <1,500 International Units Per Milliliter (IU/mL) and HBsAg <20,000 IU/mL at Weeks 12 and 24.
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 - The probability that the participant who develops an early virological/serological response would achieve HBsAg clearance 3 years post-treatment is called the PPV of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the NPV of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg negative patients, any decline in HBsAg from baseline to Week 12 and 24 and at least a 10% decline in HBsAg from baseline to Weeks 12 and 24.
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 - A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.
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 - HBeAg seroconversion is presented as percentage of participants who become HBeAg negative and anti-HBe positive. A participant was considered to have achieved HBeAg seroconversion if (a) the participant achieved HBeAg loss and (b) the anti-HBe measurement was reported as (i) 'POSITIVE' or (ii) a quantitative result considered 'positive' in the context. HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL: A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL.
Abbreviations for pt=post-treatment.
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 - A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit. This endpoint was measured in the participants with HBeAg positive CHB.
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 - A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL. If a patient received NUCs after end of PEG IFN treatment, then a reported suppression of HBV DNA to < 2,000 IU/mL during or after this NUC treatment were to be ignored, and HBV DNA = 2,000 IU/mL was to be assigned. However, HBV DNA < 2,000 IU/mL was not to be ignored, if the NUC treatment given parallel to PEG IFN was discontinued within the first 8 weeks after end of PEG IFN treatment and prior to the HBV DNA value concerned no further NUCs were administered.
Abbreviations for Seroconversion=sercnvrsn, Analysis A= AnalysA, and Analysis B= AnalysB, pt=post-treatment.
Timepoint [4] 0 0
Up to 276 Weeks
Secondary outcome [5] 0 0
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion - Hepatitis B surface antigen (HBsAg) is a viral protein detectable in the blood in acute and chronic hepatitis B infection. A participant was considered to have achieved HBsAg seroconversion if (a) the participant achieved HBsAg clearance and (b) the last approved anti-HBs measurement in the analyzed time window was reported as i) 'POSITIVE' or (ii) quantitative result and was greater than or equal to the reported lower limit of detection.
Timepoint [5] 0 0
Up to 276 Weeks
Secondary outcome [6] 0 0
Quantitative Hepatitis B Surface Antigen - Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic hepatitis B participants. Last approved quantitative HBsAg measurement in the analyzed time window.
Timepoint [6] 0 0
Up to 276 Weeks
Secondary outcome [7] 0 0
Percentage of Participants With Normalization of Alanine Transaminase - A participant was considered to have achieved normalization of alanine transaminase (ALT) if the ALT measurement was lower or equal to the upper limit of the normal range. Only patients with elevated ALT at baseline were included in any analyses where normalization of ALT was used as endpoint. It was analyzed as last serum ALT in the analyzed time window, divided by the upper limit of the normal range.
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 - ALT ratio was calculated as serum ALT, divided by the upper limit of the normal range.
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 - Number of clinical endpoints associated with CHB reported in the medical record, where data available, are reported. The clinical endpoints included liver transplantation, hepatocellular carcinoma, liver decompensation, development of cirrhosis (in patients without cirrhosis at baseline).
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 - Number of participants with clinical endpoints associated with CHB captured in the medical record, where data available, are reported. The clinical endpoints included development of cirrhosis (in participants without cirrhosis at baseline). The liver cirrhosis assessments were summarized from Week 12 to 3 years post-treatment.
Timepoint [10] 0 0
Up to 276 Weeks
Secondary outcome [11] 0 0
Number of Participants With Serious Adverse Drug Reactions - A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect.
Timepoint [11] 0 0
Up to 276 Weeks
Secondary outcome [12] 0 0
Number of Participants With Non-Serious Adverse Drug Reactions - Non serious adverse drug reactions (NSADRs) are all noxious and unintended responses to a medicinal product related to any dose.
Timepoint [12] 0 0
Up to 276 Weeks
Secondary outcome [13] 0 0
Number of Participants With Adverse Events and Serious Adverse Events - An Adverse Events (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
Timepoint [13] 0 0
Up to 276 Weeks
Secondary outcome [14] 0 0
Number of Deaths During Observation Period - The clinical endpoint of deaths due to any cause during observation period is presented.
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
Gender
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
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 outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
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Austria
State/province [2] 0 0
Innsbruck
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Austria
State/province [3] 0 0
Linz
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Austria
State/province [4] 0 0
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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Bosnia and Herzegovina
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Bihac
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Bosnia and Herzegovina
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Mostar
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Bosnia and Herzegovina
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Sarajevo
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Bosnia and Herzegovina
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Tuzla
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Bosnia and Herzegovina
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Zenica
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Bulgaria
State/province [13] 0 0
Sofia
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Bulgaria
State/province [14] 0 0
Varna
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China
State/province [15] 0 0
Beijing
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China
State/province [16] 0 0
Chengdu
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China
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Chongqing
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China
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Guangzhou
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China
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Hangzhou
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China
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Harbin
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China
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Jinan
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Nanjing
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China
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Shanghai
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China
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Shen Zhen
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China
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ShenYang
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China
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Shi Jiazhuang
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China
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Shijiazhuang
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China
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Urumqi
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China
State/province [29] 0 0
Wenzhou
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China
State/province [30] 0 0
Xi'an
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Egypt
State/province [31] 0 0
Cairo
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Egypt
State/province [32] 0 0
Giza
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Egypt
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Mansoura
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France
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Aix En Provence
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France
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Amiens
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Angers
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Argenteuil
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Avignon
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Besancon
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Bobigny
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Bondy
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Bordeaux
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Bourgoin Jallieu
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Caen
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Clamart
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Clichy
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Creil
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Le Mans
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Lille
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Limoges
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Lyon
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Marseille
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Metz
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Montauban
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Montivilliers
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Montpellier
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Mulhouse
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Nantes
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Nimes
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Niort
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Orleans
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Paris
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Perpignan
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Pessac
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Reims
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Rennes
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Rouen
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Saint Laurent Du Var
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St Maurice
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Toulon
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Toulouse
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Vandoeuvre-les-nancy
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Villejuif
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Germany
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Berlin
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Bonn
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Germany
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Düsseldorf
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Germany
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Erlangen
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Essen
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Germany
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Frankfurt am Main
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Germany
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Freiburg
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Germany
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Giessen
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Germany
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Hamburg
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Germany
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Hamm
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Herne
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Jena
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Kiel
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Lübeck
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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München
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Germany
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Münster
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Germany
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Nürnberg
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Germany
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Offenburg
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Germany
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Salzgitter
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Germany
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Stuttgart
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Germany
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Ulm
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Germany
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Wuerzburg
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Germany
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Wuppertal
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Hong Kong
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Tuen Mun
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India
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Delhi
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India
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Gurgaon
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India
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Guwahati
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India
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Mumbai
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India
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Pune
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India
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Trivandrum
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Indonesia
State/province [119] 0 0
Bandung
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Indonesia
State/province [120] 0 0
Jakarta
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Indonesia
State/province [121] 0 0
Surabaya
Country [122] 0 0
Indonesia
State/province [122] 0 0
Tangerang
Country [123] 0 0
Ireland
State/province [123] 0 0
Dublin
Country [124] 0 0
Jordan
State/province [124] 0 0
Amman
Country [125] 0 0
Jordan
State/province [125] 0 0
Irbid
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Anyang
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Busan
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Chooncheon
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Korea, Republic of
State/province [129] 0 0
Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeollabuk-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Seoungnamsi
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Korea, Republic of
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Ulsan
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Lebanon
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Beirut
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Macedonia, The Former Yugoslav Republic of
State/province [137] 0 0
Skopje
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Morocco
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Casablanca
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Morocco
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Fes
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Morocco
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Rabat
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New Zealand
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Auckland
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New Zealand
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Hamilton
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New Zealand
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Whakatane
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Pakistan
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Faisalabad
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Pakistan
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Islamabad
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Pakistan
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Karachi
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Pakistan
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Lahore
Country [148] 0 0
Pakistan
State/province [148] 0 0
Peshawar
Country [149] 0 0
Pakistan
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Rawalpindi
Country [150] 0 0
Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Chorzow
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Lancut
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Poland
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Lodz
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Poland
State/province [157] 0 0
Warszawa
Country [158] 0 0
Poland
State/province [158] 0 0
Wroclaw
Country [159] 0 0
Poland
State/province [159] 0 0
Zielona Góra
Country [160] 0 0
Portugal
State/province [160] 0 0
Lisboa
Country [161] 0 0
Portugal
State/province [161] 0 0
Porto
Country [162] 0 0
Romania
State/province [162] 0 0
Bucharest
Country [163] 0 0
Romania
State/province [163] 0 0
Craiova
Country [164] 0 0
Saudi Arabia
State/province [164] 0 0
Alkhobar
Country [165] 0 0
Saudi Arabia
State/province [165] 0 0
Riyadh
Country [166] 0 0
Saudi Arabia
State/province [166] 0 0
Tabuk
Country [167] 0 0
Thailand
State/province [167] 0 0
Bangkok
Country [168] 0 0
Thailand
State/province [168] 0 0
Chiang Mai
Country [169] 0 0
Thailand
State/province [169] 0 0
Songkhla
Country [170] 0 0
United Arab Emirates
State/province [170] 0 0
Dubai
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Hull
Country [172] 0 0
United Kingdom
State/province [172] 0 0
London
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Manchester

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/show/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
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