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An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

NCT ID: NCT02118597

Last Updated: 2016-12-12

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

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-05-31

Brief Summary

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This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.

Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Triple Combination Therapy

Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.

Boceprevir

Intervention Type DRUG

Boceprevir administered according to corresponding summary of product characteristics (SmPC).

Simeprevir

Intervention Type DRUG

Simeprevir administered according to corresponding summary of product characteristics (SmPC).

Pegylated Interferon (Peginterferon) Alfa-2a

Intervention Type DRUG

Pegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC).

Ribavirin

Intervention Type DRUG

Ribavirin according to corresponding summary of product characteristics (SmPC).

Interventions

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Boceprevir

Boceprevir administered according to corresponding summary of product characteristics (SmPC).

Intervention Type DRUG

Simeprevir

Simeprevir administered according to corresponding summary of product characteristics (SmPC).

Intervention Type DRUG

Pegylated Interferon (Peginterferon) Alfa-2a

Pegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC).

Intervention Type DRUG

Ribavirin

Ribavirin according to corresponding summary of product characteristics (SmPC).

Intervention Type DRUG

Other Intervention Names

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Victrelis Olysio Pegasys Copegus

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or over
* Genotype 1 CHC infection
* Prior unsuccessful treatment with peginterferon alfa plus ribavirin (null-response, partial response and relapsed participants)
* Receiving triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin according to standard of care and in line with local labeling
* Enrollment in the study no later than 4 weeks after start of triple combination therapy (including peginterferon alfa-2a and ribavirin lead-in phase)

Exclusion Criteria

* Naïve participants not responding to peginterferon alfa plus ribavirin at week 4 (HCV RNA drop \< 1 log10) or at week 12 (HCV RNA \>/= 15 international units/milliliter \[IU/mL\]) and switching to triple combination therapy with boceprevir
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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Békéscsaba, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Debrecen, , Hungary

Site Status

Eger, , Hungary

Site Status

Kaposvár, , Hungary

Site Status

Szombathely, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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ML29278

Identifier Type: -

Identifier Source: org_study_id