A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a)

NCT ID: NCT01585324

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

Brief Summary

This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type: DRUG

180 mcg subcutaneously weekly

ribavirin [Copegus]

Intervention Type: DRUG

1000 mg or 1200 mg orally daily

Interventions

peginterferon alfa-2a [Pegasys]

180 mcg subcutaneously weekly

Intervention Type: DRUG

ribavirin [Copegus]

1000 mg or 1200 mg orally daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Chronic hepatitis C, genotype 1
• Treatment-naïve or patients who relapsed or failed to respond to previous combination therapy with interferon and ribavirin
• Detectable HCV-RNA
• Fertile males and females of child-bearing potential must agree to use two forms of contraception during treatment and for 6 months after treatment end

Exclusion Criteria

• Pregnant or breast-feeding women
• Male partners of pregnant women
• History or evidence of a medical condition associated with chronic liver disease other than HCV
• Co-infection with active hepatitis A, hepatitis B and/or HIV virus
• Hepatocellular carcinoma
• History or evidence of oesophageal varices or other conditions consistent with decompensated liver disease
• Anemia
• Any patient with increased baseline risk for anemia (e.g. thalassemia, spherocyctosis, history of GI bleeding)
• History or evidence of significant cardiovascular disease
• Kidney disease
• Severe retinopathy
• History of severe psychiatric disease, especially depression
• Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) </= 6 months prior to first dose of study drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Most, , Czechia

Countries

Czechia

Other Identifiers

2011-001256-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML25186

Identifier Type: -

Identifier Source: org_study_id