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A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

NCT ID: NCT01033448

Last Updated: 2017-10-03

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

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-06-30

Brief Summary

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This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

COPEGUS

Intervention Type DRUG

COPEGUS 800 mg or 1000-1200 mg po for 24 weeks

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

PEGASYS 180 micrograms sc once weekly for 24 weeks

Interventions

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COPEGUS

COPEGUS 800 mg or 1000-1200 mg po for 24 weeks

Intervention Type DRUG

peginterferon alfa-2a [Pegasys]

PEGASYS 180 micrograms sc once weekly for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients \>/= 18 years of age
* Chronic hepatitis C, genotype 1, 2, 3
* Compensated liver disease
* Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders

Exclusion Criteria

* Decompensated liver disease
* Signs or symptoms of hepatocellular carcinoma
* Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
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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Haemek Hospital; Gastroenterology

Afula, , Israel

Site Status

Clalit City Ashdod MC; Liver Clinic

Ashdod, , Israel

Site Status

Batyamon; Liver Unit

Bat Yam, , Israel

Site Status

Soroka Medical Center; Gastroenterology

Beersheba, , 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

Hadassah Hospital; Liver Unit

Jerusalem, , Israel

Site Status

Clalit Strauss MC

Jerusalem, , Israel

Site Status

Meir Medical Center; Gastroenterology

Kfar Saba, , Israel

Site Status

Naharyia / Western Galilee MC; Gastro Unit

Nahariya, , Israel

Site Status

Holy Family Medical Center; Gastroenterology

Nazareth, , Israel

Site Status

Rabin Medical Center; Gastroenterology - Liver Unit

Petah Tikva, , Israel

Site Status

Kaplan Medical Center; Gastroenterology Unit

Rehovot, , Israel

Site Status

Clalit Pinsker Rishon; Liver Clinic

Rishon LeZiyyon, , Israel

Site Status

Rebecca Sieff Medical Center; Liver Unit

Safed, , Israel

Site Status

Maccabi Health Services MC

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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ML21778

Identifier Type: -

Identifier Source: org_study_id