An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

NCT ID: NCT01392742

Last Updated: 2017-04-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

443 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-07-31

Brief Summary

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This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.

Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Serologically confirmed chronic hepatitis C (all genotypes)
* Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Exclusion Criteria

* Coinfection with HIV and/or hepatitis B
* Contraindications according to the SPC for Pegasys/ribavirin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Mhat - Pleven; Clinic of Gastroenterology

Pleven, , Bulgaria

Site Status

Umhat St. Georgi; Clinical of Gastroenterology

Plovdiv, , Bulgaria

Site Status

MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases

Sofia, , Bulgaria

Site Status

UMHAT Alexandrovska EAD; Gastroenterology

Sofia, , Bulgaria

Site Status

Mhat Queenjoanna; Clinic of Gastroenterology

Sofia, , Bulgaria

Site Status

Military Medical Academy; Gastroenterology

Sofia, , Bulgaria

Site Status

Mhat St. Ivan Rilski; Clinic of Gastroenterology

Sofia, , Bulgaria

Site Status

Mhat St. Zagora; Clinical of Gastroenterology

Stara Zagora, , Bulgaria

Site Status

Mhat Sveta Marina; Clinic of Gastroenterology

Varna, , Bulgaria

Site Status

Countries

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Bulgaria

Other Identifiers

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ML25670

Identifier Type: -

Identifier Source: org_study_id

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