Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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)
Query!
Secondary ID [1]
0
0
MV22009
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Cohort -
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance
Query!
Assessment method [1]
0
0
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").
Query!
Timepoint [1]
0
0
Up to 276 Weeks
Query!
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to 276 Weeks
Query!
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
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Up to 276 Weeks
Query!
Secondary outcome [1]
0
0
Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to 276 Weeks
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to 276 Weeks
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Up to 276 Weeks
Query!
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
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Up to 276 Weeks
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Up to 276 Weeks
Query!
Secondary outcome [6]
0
0
Quantitative Hepatitis B Surface Antigen
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Up to 276 Weeks
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Normalization of Alanine Transaminase
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Up to 276 Weeks
Query!
Secondary outcome [8]
0
0
Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status
Query!
Assessment method [8]
0
0
ALT ratio was calculated as serum ALT, divided by the upper limit of the normal range.
Query!
Timepoint [8]
0
0
Up to 276 Weeks
Query!
Secondary outcome [9]
0
0
Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation
Query!
Assessment method [9]
0
0
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).
Query!
Timepoint [9]
0
0
Up to 276 Weeks
Query!
Secondary outcome [10]
0
0
Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Up to 276 Weeks
Query!
Secondary outcome [11]
0
0
Number of Participants With Serious Adverse Drug Reactions
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Up to 276 Weeks
Query!
Secondary outcome [12]
0
0
Number of Participants With Non-Serious Adverse Drug Reactions
Query!
Assessment method [12]
0
0
Non serious adverse drug reactions (NSADRs) are all noxious and unintended responses to a medicinal product related to any dose.
Query!
Timepoint [12]
0
0
Up to 276 Weeks
Query!
Secondary outcome [13]
0
0
Number of Participants With Adverse Events and Serious Adverse Events
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Up to 276 Weeks
Query!
Secondary outcome [14]
0
0
Number of Deaths During Observation Period
Query!
Assessment method [14]
0
0
The clinical endpoint of deaths due to any cause during observation period is presented.
Query!
Timepoint [14]
0
0
Up to 276 Weeks
Query!
Eligibility
Key inclusion criteria
* adult patient, >/= 18 years of age
* chronic hepatitis B
* treatment with peginterferon alfa-2A
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* coinfection with HAV, HCV and HIV
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/04/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
18/11/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1842
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Graz
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Innsbruck
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Linz
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Wien
Query!
Country [5]
0
0
Bahrain
Query!
State/province [5]
0
0
Manama
Query!
Country [6]
0
0
Bangladesh
Query!
State/province [6]
0
0
Dhaka
Query!
Country [7]
0
0
Bosnia and Herzegovina
Query!
State/province [7]
0
0
Banja Luka
Query!
Country [8]
0
0
Bosnia and Herzegovina
Query!
State/province [8]
0
0
Bihac
Query!
Country [9]
0
0
Bosnia and Herzegovina
Query!
State/province [9]
0
0
Mostar
Query!
Country [10]
0
0
Bosnia and Herzegovina
Query!
State/province [10]
0
0
Sarajevo
Query!
Country [11]
0
0
Bosnia and Herzegovina
Query!
State/province [11]
0
0
Tuzla
Query!
Country [12]
0
0
Bosnia and Herzegovina
Query!
State/province [12]
0
0
Zenica
Query!
Country [13]
0
0
Bulgaria
Query!
State/province [13]
0
0
Sofia
Query!
Country [14]
0
0
Bulgaria
Query!
State/province [14]
0
0
Varna
Query!
Country [15]
0
0
China
Query!
State/province [15]
0
0
Beijing
Query!
Country [16]
0
0
China
Query!
State/province [16]
0
0
Chengdu
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Chongqing
Query!
Country [18]
0
0
China
Query!
State/province [18]
0
0
Guangzhou
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Hangzhou
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Harbin
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Jinan
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Nanjing
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Shanghai
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Shen Zhen
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
ShenYang
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Shi Jiazhuang
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Shijiazhuang
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Urumqi
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Wenzhou
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Xi'an
Query!
Country [31]
0
0
Egypt
Query!
State/province [31]
0
0
Cairo
Query!
Country [32]
0
0
Egypt
Query!
State/province [32]
0
0
Giza
Query!
Country [33]
0
0
Egypt
Query!
State/province [33]
0
0
Mansoura
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Aix En Provence
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Amiens
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Angers
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Argenteuil
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Avignon
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Besancon
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Bobigny
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Bondy
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Bordeaux
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Bourgoin Jallieu
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Caen
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Chambray Les Tours
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Clamart
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Clermont Ferrand
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Clichy
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Corbeil Essonnes
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Creil
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Creteil
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Dijon
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Evry
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Grasse
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
La Tronche
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Lagny Sur Marne
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Le Kremlin Bicetre
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Le Mans
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Lille
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Limoges
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Lyon
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Marseille
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Metz
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Montauban
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Montivilliers
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Montpellier
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Mulhouse
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Nantes
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Nimes
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Niort
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Orleans
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Paris
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Perpignan
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Pessac
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Reims
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Rennes
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Rouen
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Saint Laurent Du Var
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
St Maurice
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Strasbourg
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Toulon
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Toulouse
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Vandoeuvre-les-nancy
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Villejuif
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Berlin
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Bonn
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Düsseldorf
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Erlangen
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Essen
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Frankfurt am Main
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Freiburg
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Giessen
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Hamburg
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Hamm
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Hannover
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Heidelberg
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Herne
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Jena
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Kiel
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Lübeck
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Magdeburg
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Mainz
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
München
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Münster
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Nürnberg
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Offenburg
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Salzgitter
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Stuttgart
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Ulm
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Wuerzburg
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Wuppertal
Query!
Country [112]
0
0
Hong Kong
Query!
State/province [112]
0
0
Tuen Mun
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
Delhi
Query!
Country [114]
0
0
India
Query!
State/province [114]
0
0
Gurgaon
Query!
Country [115]
0
0
India
Query!
State/province [115]
0
0
Guwahati
Query!
Country [116]
0
0
India
Query!
State/province [116]
0
0
Mumbai
Query!
Country [117]
0
0
India
Query!
State/province [117]
0
0
Pune
Query!
Country [118]
0
0
India
Query!
State/province [118]
0
0
Trivandrum
Query!
Country [119]
0
0
Indonesia
Query!
State/province [119]
0
0
Bandung
Query!
Country [120]
0
0
Indonesia
Query!
State/province [120]
0
0
Jakarta
Query!
Country [121]
0
0
Indonesia
Query!
State/province [121]
0
0
Surabaya
Query!
Country [122]
0
0
Indonesia
Query!
State/province [122]
0
0
Tangerang
Query!
Country [123]
0
0
Ireland
Query!
State/province [123]
0
0
Dublin
Query!
Country [124]
0
0
Jordan
Query!
State/province [124]
0
0
Amman
Query!
Country [125]
0
0
Jordan
Query!
State/province [125]
0
0
Irbid
Query!
Country [126]
0
0
Korea, Republic of
Query!
State/province [126]
0
0
Anyang
Query!
Country [127]
0
0
Korea, Republic of
Query!
State/province [127]
0
0
Busan
Query!
Country [128]
0
0
Korea, Republic of
Query!
State/province [128]
0
0
Chooncheon
Query!
Country [129]
0
0
Korea, Republic of
Query!
State/province [129]
0
0
Daegu
Query!
Country [130]
0
0
Korea, Republic of
Query!
State/province [130]
0
0
Daejeon
Query!
Country [131]
0
0
Korea, Republic of
Query!
State/province [131]
0
0
Incheon
Query!
Country [132]
0
0
Korea, Republic of
Query!
State/province [132]
0
0
Jeollabuk-do
Query!
Country [133]
0
0
Korea, Republic of
Query!
State/province [133]
0
0
Seoul
Query!
Country [134]
0
0
Korea, Republic of
Query!
State/province [134]
0
0
Seoungnamsi
Query!
Country [135]
0
0
Korea, Republic of
Query!
State/province [135]
0
0
Ulsan
Query!
Country [136]
0
0
Lebanon
Query!
State/province [136]
0
0
Beirut
Query!
Country [137]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [137]
0
0
Skopje
Query!
Country [138]
0
0
Morocco
Query!
State/province [138]
0
0
Casablanca
Query!
Country [139]
0
0
Morocco
Query!
State/province [139]
0
0
Fes
Query!
Country [140]
0
0
Morocco
Query!
State/province [140]
0
0
Rabat
Query!
Country [141]
0
0
New Zealand
Query!
State/province [141]
0
0
Auckland
Query!
Country [142]
0
0
New Zealand
Query!
State/province [142]
0
0
Hamilton
Query!
Country [143]
0
0
New Zealand
Query!
State/province [143]
0
0
Whakatane
Query!
Country [144]
0
0
Pakistan
Query!
State/province [144]
0
0
Faisalabad
Query!
Country [145]
0
0
Pakistan
Query!
State/province [145]
0
0
Islamabad
Query!
Country [146]
0
0
Pakistan
Query!
State/province [146]
0
0
Karachi
Query!
Country [147]
0
0
Pakistan
Query!
State/province [147]
0
0
Lahore
Query!
Country [148]
0
0
Pakistan
Query!
State/province [148]
0
0
Peshawar
Query!
Country [149]
0
0
Pakistan
Query!
State/province [149]
0
0
Rawalpindi
Query!
Country [150]
0
0
Poland
Query!
State/province [150]
0
0
Bialystok
Query!
Country [151]
0
0
Poland
Query!
State/province [151]
0
0
Bydgoszcz
Query!
Country [152]
0
0
Poland
Query!
State/province [152]
0
0
Chorzow
Query!
Country [153]
0
0
Poland
Query!
State/province [153]
0
0
Gdansk
Query!
Country [154]
0
0
Poland
Query!
State/province [154]
0
0
Krakow
Query!
Country [155]
0
0
Poland
Query!
State/province [155]
0
0
Lancut
Query!
Country [156]
0
0
Poland
Query!
State/province [156]
0
0
Lodz
Query!
Country [157]
0
0
Poland
Query!
State/province [157]
0
0
Warszawa
Query!
Country [158]
0
0
Poland
Query!
State/province [158]
0
0
Wroclaw
Query!
Country [159]
0
0
Poland
Query!
State/province [159]
0
0
Zielona Góra
Query!
Country [160]
0
0
Portugal
Query!
State/province [160]
0
0
Lisboa
Query!
Country [161]
0
0
Portugal
Query!
State/province [161]
0
0
Porto
Query!
Country [162]
0
0
Romania
Query!
State/province [162]
0
0
Bucharest
Query!
Country [163]
0
0
Romania
Query!
State/province [163]
0
0
Craiova
Query!
Country [164]
0
0
Saudi Arabia
Query!
State/province [164]
0
0
Alkhobar
Query!
Country [165]
0
0
Saudi Arabia
Query!
State/province [165]
0
0
Riyadh
Query!
Country [166]
0
0
Saudi Arabia
Query!
State/province [166]
0
0
Tabuk
Query!
Country [167]
0
0
Thailand
Query!
State/province [167]
0
0
Bangkok
Query!
Country [168]
0
0
Thailand
Query!
State/province [168]
0
0
Chiang Mai
Query!
Country [169]
0
0
Thailand
Query!
State/province [169]
0
0
Songkhla
Query!
Country [170]
0
0
United Arab Emirates
Query!
State/province [170]
0
0
Dubai
Query!
Country [171]
0
0
United Kingdom
Query!
State/province [171]
0
0
Hull
Query!
Country [172]
0
0
United Kingdom
Query!
State/province [172]
0
0
London
Query!
Country [173]
0
0
United Kingdom
Query!
State/province [173]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01011738
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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/NCT01011738
Download to PDF