An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01011738
First received: November 10, 2009
Last updated: December 3, 2012
Last verified: December 2012
| Tracking Information | |||||
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| First Received Date ICMJE | November 10, 2009 | ||||
| Last Updated Date | December 3, 2012 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
HBsAg clearance [ Time Frame: on treatment and up to 5 years follow-up ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01011738 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys | ||||
| Official Title ICMJE | 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) | ||||
| 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 are followed for up to 5 years. Target sample size is <2500. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with chronic hepatitis C receiving treatment with peginterferon alfa-2a 40KD (Pegasys) |
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| Condition ICMJE | Hepatitis B, Chronic | ||||
| Intervention ICMJE | Drug: peginterferon alfa-2a [Pegasys]
As prescribed by physician |
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| Study Group/Cohort (s) | Cohort
Intervention: Drug: peginterferon alfa-2a [Pegasys] |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 1849 | ||||
| Estimated Completion Date | April 2015 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria, Bahrain, Bangladesh, Bosnia and Herzegovina, Bulgaria, China, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Jordan, Korea, Republic of, Lebanon, Macedonia, The Former Yugoslav Republic of, Morocco, New Zealand, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Thailand, United Arab Emirates, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01011738 | ||||
| Other Study ID Numbers ICMJE | MV22009 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Hoffmann-La Roche | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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