An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

NCT ID: NCT01604291

Last Updated: 2019-03-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

991 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-28

Study Completion Date

2016-02-10

Brief Summary

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This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

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
* Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
* Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
* No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
* Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion Criteria

* Hepatitis A/B co-infection
* Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* Pregnant or breast-feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clalit Health Services

OTHER

Sponsor Role collaborator

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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Rebecca Sieff Medical Center; Liver Unit

Safed, , Israel

Site Status

Haemek Hospital; Gastroenterology

Afula, , Israel

Site Status

Barzilai MC; Gastroenterology

Ashkelon, , Israel

Site Status

Soroka Medical Center; Gastroenterology

Beersheba, , Israel

Site Status

Hillel Yaffe Hospital; Gastroenterology

Hadera, , Israel

Site Status

Rambam Medical Center; Gastroenterology - Liver Unit

Haifa, , Israel

Site Status

Bnei-Zion Medical Center; Gastroenterology

Haifa, , Israel

Site Status

Carmel Hospital; Liver Unit

Haifa, , Israel

Site Status

Wolfson Hospital; Gastroenterology Unit

Holon, , Israel

Site Status

Shaare Zedek Hospital Liver Unit; Liver Unit

Jerusalem, , Israel

Site Status

Hadassah Hospital; Liver Unit

Jerusalem, , Israel

Site Status

Meir Medical Center; Liver Unit

Kfar Saba, , Israel

Site Status

Western Galilee Hospital - Nahariya

Nahariya, , Israel

Site Status

Holy Family Medical Center; Liver Unit

Nazareth, , Israel

Site Status

Beilinson-Rabin Liver Unit; Liver Unit

Petah Tikva, , Israel

Site Status

Hasharon Mc; Gastroenterology

Petah Tikva, , Israel

Site Status

Sheba Medical Center; Tel Hashomer

Ramat Gan, , Israel

Site Status

Kaplan Medical Center; Gastroenterology Unit

Rehovot, , Israel

Site Status

Tel-Aviv Sourasky Medical Center; Liver Unit

Tel Aviv, , Israel

Site Status

Poria Hospital; Gastroenterology

Tiberias, , Israel

Site Status

Assaf Harofeh; Gastroenterology

Ẕerifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ML28268

Identifier Type: -

Identifier Source: org_study_id

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