A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin)

This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: peginterferon alfa-2a; Drug: ribavirin [Copegus]

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • BA
    • Salvador, BA, Brazil, 41110-170
  • ES
    • Vitoria, ES, Brazil, 29043-260
  • MG
    • Juiz de Fora, MG, Brazil, 36038-330
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20020-022
    • Rio de Janeiro, RJ, Brazil, 20270-004
  • SC
    • Joinville, SC, Brazil, 89202-050
    • Sao Jose Do Rio Preto, SC, Brazil, 15090-000
  • SP
    • Botucatu, SP, Brazil, 18600-400
    • Campinas, SP, Brazil, 13026-210
    • Campinas, SP, Brazil, 13060-803
    • Santos, SP, Brazil, 11015470
    • Sao Paulo, SP, Brazil, 04040-003
    • Sao Paulo, SP, Brazil, 04119-001
    • Sao Paulo, SP, Brazil, 04266-010
    • Sorocaba, SP, Brazil, 18047-600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients, >/=18 and <70 years of age at initiation of treatment
• Body weight between 50 kg and 125 kg at baseline
• Chronic hepatitis C, genotype 1
• Chronic liver disease consistent with HCV infection
• Compensated liver disease (Child-Pugh Grade A)

Exclusion Criteria:

• Pregnant or lactating women, and male partners of pregnant women
• Chronic hepatitis C, genotype 2, 3, 4, 5 or 6
• Previous treatment with interferon or ribavirin
• Positive for hepatitis A, hepatitis B or HIV infection
• History or evidence of a medical condition associated with liver disease other than chronic hepatitis C
• Decompensated liver disease and/or liver disease Child-Pugh classification >6
• Hepatocellular carcinoma
• History or evidence of esophageal bleeding
• Hemoglobinopathy, or any other cause for possible hemolysis
• Hb <11 g/dL in women, <12 g/L in males

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peginterferon Alfa-2a Plus Ribavirin	Drug: peginterferon alfa-2a; 180 mcg sc weekly, 48 weeks; Drug: ribavirin [Copegus]; 1'000 or 1'200 mg orally daily, 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression	Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.	At Week 72
Percentage of Participants With Incidence of Anemia	Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb < 11 gram per decilitre (g/dL) for women and Hb < 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.	Up to Week 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression	Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a >= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.	Weeks 4, 12, 24, 48, 60 and 72
Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment	Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.	Up to Week 72
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12	Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: < 1.0 log IU/ml; >= 1.0 and < 2.0 log IU/ml; >= 2.0 and < 3.0 log IU/ml; >= 3.0 and <4.0 log IU/ml; >= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.	From Baseline (Week 0) to Week 12

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: October 4, 2011
• First Submitted That Met QC Criteria: October 4, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: June 24, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin; Peginterferon alfa-2a
• Other Study ID Numbers: ML25592