Trial record 1 of 24 for:
IL28B Polymorphism in
A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01697501
First received: September 28, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B, Chronic |
Other: Interleukin 28B testing |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Cross-sectional Multicenter Study Evaluating the IL28B Polymorphism in Patients With HBeAg-negative Chronic Hepatitis B Treated With Pegylated Interferon Alfa-2a in the Course of Peg.Be.Liver Study |
Resource links provided by NLM:
Drug Information available for:
Peginterferon Alfa-2a
Recombinant Hepatitis B vaccine
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Percentage of patients with sustained virological response (SVR) observed in ML18253 according to IL28B genotypes. SVR is defined as HBV DNA </= 2000 UI/ml at the end of the treatment-free follow-up [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of patients with HBsAg clearance (defined as HBsAg <0.05 UI/ml) according to IL28B genotypes at end of treatment/end of follow-up in ML18253 [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
- Percentage of patients with HBsAg </= 10 IU/ml at end of treatment/end of follow-up according to IL28B genotypes in ML18253 [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
- HBsAg kinetic according to IL28B genotypes during treatment/follow-up in ML18253 [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
- Percentage of patients with virologic response at the end of treatment (HBV DNA </= 200 UI/ml) observed in ML18253 according to IL28B genotype. [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 112 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Chronic hepatitis B patients |
Other: Interleukin 28B testing
Blood sampling for IL28B genotyping
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Chronic hepatitis B
- Previous participation in study ML18253
- Administration of at least one dose of the study drug during ML18253 study
Exclusion Criteria:
- Patients not satisfying the above inclusion criteria will not be enrolled in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697501
Contacts
| Contact: Please reference Study ID Number: ML28470 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Italy | |
| Recruiting | |
| Bari, Italy, 70124 | |
| Not yet recruiting | |
| Bologna, Italy, 40138 | |
| Recruiting | |
| Cagliari, Italy, 09042 | |
| Not yet recruiting | |
| Caserta, Italy, 81100 | |
| Recruiting | |
| Castellana Grotte, Italy, 70013 | |
| Recruiting | |
| Milano, Italy, 20122 | |
| Completed | |
| Milano, Italy, 20122 | |
| Not yet recruiting | |
| Napoli, Italy, 80131 | |
| Recruiting | |
| Napoli, Italy, 80131 | |
| Recruiting | |
| Padova, Italy, 35128 | |
| Recruiting | |
| Palermo, Italy, 90127 | |
| Completed | |
| Parma, Italy, 43100 | |
| Completed | |
| Pisa, Italy, 56124 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01697501 History of Changes |
| Other Study ID Numbers: | ML28470, 2012-002777-56 |
| Study First Received: | September 28, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Italy: Agenzia Italiana del Farmaco (AIFA) |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013