Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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)

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 4, 2011
Last updated: June 24, 2016
Last verified: June 2016
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.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a
Drug: ribavirin [Copegus]
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression [ Time Frame: At Week 72 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Incidence of Anemia [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression [ Time Frame: Weeks 4, 12, 24, 48, 60 and 72 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 [ Time Frame: From Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
    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.

Enrollment: 129
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01447420

Salvador, BA, Brazil, 41110-170
Vitoria, ES, Brazil, 29043-260
Juiz de Fora, MG, Brazil, 36038-330
Rio de Janeiro, RJ, Brazil, 20020-022
Rio de Janeiro, RJ, Brazil, 20270-004
Joinville, SC, Brazil, 89202-050
Sao Jose Do Rio Preto, SC, Brazil, 15090-000
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
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01447420     History of Changes
Other Study ID Numbers: ML25592 
Study First Received: October 4, 2011
Results First Received: May 18, 2016
Last Updated: June 24, 2016
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016