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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002777-56 | EudraCT Number |
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This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the predecessor ML18253 study. The study consists of a single visit where eligible patients will undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic hepatitis B patients | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin 28B testing | Other | Blood sampling for IL28B genotyping |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF) | EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment. | |
| Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF | EoF |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT) | EoT, as defined in the predecessor study, was at Week 48 or Week 96 | |
| Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive | Bari | Apulia | 70124 | Italy | ||
Participants in the full analysis set included 86 previously enrolled in the predecessor study ML18253 (NCT01095835), during which they were treated.
Participants in the safety analysis set included 88 patients with HBeAg-negative chronic hepatitis B enrolled at 12 study centers in Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Hepatitis B Patients | Interleukin 28B testing: Blood sampling for IL28B genotyping |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| EoT |
| Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT and EoF |
| Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT and EoF |
| Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT and EoF |
| Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT and EoF |
| Ospedale de Bellis; Reparto Medicina Generale |
| Castellana Grotte |
| Apulia |
| 70013 |
| Italy |
| Az. Osp. S. Sebastiano; Divisione Malattie Infettive | Caserta | Campania | 81100 | Italy |
| Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia | Naples | Campania | 80131 | Italy |
| UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In | Bologna | Emilia-Romagna | 40138 | Italy |
| Az. Osp. Uni Ria Di Parma; Gastro-Enterology | Parma | Emilia-Romagna | 43100 | Italy |
| Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia | Milan | Lombardy | 20122 | Italy |
| Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale | Milan | Lombardy | 20122 | Italy |
| Uni Di Cagliari; Dept. Di Scienze Mediche | Cagliari | Sardinia | 09042 | Italy |
| Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia | Palermo | Sicily | 90127 | Italy |
| Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia | Pisa | Tuscany | 56124 | Italy |
| Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent. | Padova | Veneto | 35128 | Italy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Hepatitis B Patients | Interleukin 28B testing: Blood sampling for IL28B genotyping |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF) | Full analysis set (FAS), defined as all subjects who completed | Posted | Number | percentage of participants | EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment. |
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| Primary | Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF | FAS | Posted | Number | percentage of participants | EoF |
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| Secondary | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT) | Full analysis set (FAS), defined as all subjects who completed | Posted | Number | percentage of participants | EoT, as defined in the predecessor study, was at Week 48 or Week 96 |
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| Secondary | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT | FAS | Posted | Number | percentage of participants | EoT |
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| Secondary | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | Full analysis set (FAS), defined as all subjects who completed | Posted | Number | percentage of participants | EoT and EoF |
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| Secondary | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | FAS | Posted | Number | percentage of participants | EoT and EoF |
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| Secondary | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | Full analysis set (FAS), defined as all subjects who completed | Posted | Number | percentage of participants | EoT and EoF |
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| Secondary | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | FAS | Posted | Number | percentage of participants | EoT and EoF |
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The study consisted of a single visit where eligible patients undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit. All subjects enrolled are included in the safety analysis set.
Adverse events were to be reported on a per subject basis by severity and relationship to study procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Hepatitis B Patients | Interleukin 28B testing: Blood sampling for IL28B genotyping | 0 | 88 | 0 | 88 |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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