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A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)

NCT01429792•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
•Documented pre-treatment HCV RNA quantitative result
•Compensated liver disease (Child-Pugh Grade A)
•Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)

Exclusion Criteria

•Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
•Co-infection with active hepatitis A and/or hepatitis B
•History or evidence of a medical condition associated with liver disease other than HCV
•Signs and symptoms of hepatocellular carcinoma
•History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
•Therapy with antineoplastic treatment \</= 6 months prior to study day
•Diabetes mellitus in subjects receiving an insulin therapy
•Evidence of severe retinopathy
•Pregnant or breast-feeding women, and male partners of women who are pregnant

Locations (26)

Haemek Hospital; Gastroenterology

Afula, Israel

Clalit City Ashdod MC; Liver Clinic

Ashdod, Israel

Barzilai MC; Gastroenterology

Ashkelon, Israel

Batyamon; Liver Unit

Bat Yam, Israel

Soroka Medical Center; Liver Unit

Beersheba, Israel

Soroka Medical Center; Gastroenterology

Beersheba, Israel

Rambam Medical Center; Gastroenterology - Liver Unit

Haifa, Israel

Bnei-Zion Medical Center; Gastroenterology

Haifa, Israel

Carmel Hospital; Liver Unit

Haifa, Israel

Wolfson Hospital; Gastroenterology Unit

Holon, Israel

Key Dates

Start Date

September 25, 2008

Primary Completion Date

June 10, 2013

Completion Date

June 10, 2013

Last Updated

October 23, 2018

Enrollment

1,013

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a [Pegasys]

DRUG

ribavirin [Copegus]

DRUG

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Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection