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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01447420
First received: October 4, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Compare Sustained Virological Response in Function of Expression Profile of IL28-b in naïve Patients With Chronic Infection by HCV Genotype 1, With Hepatitis C, Receiving Pegasys and Ribavirin

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Rate of sustained virological response (undetectable HCV RNA 24 weeks after end of treatment) in relation to Interleukin 28B (IL28-b) expression [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Incidence of anemia [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (rapid/early/end of treatment) in relation to IL28-b expression [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Correlation between sustained virological response and anemia (Hb levels) during the first month of treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Correlation between sustained virological response and anemia (Hb levels) after the first month of treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Correlation between viral load (HCV RNA levels) 12 weeks after the end of treatment and sustained virological response [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

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: Single Arm Drug: peginterferon alfa-2a
180 mcg sc weekly, 48 weeks
Drug: ribavirin [Copegus]
1'000 or 1'200 mg orally daily, 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01447420

Locations
Brazil
Salvador, BA, Brazil, 41110-170
Vitoria, ES, Brazil, 29043-260
Juiz de Fora, MG, Brazil, 36038-330
Rio de Janeiro, RJ, Brazil, 20270-004
Rio de Janeiro, RJ, Brazil, 20020-022
Joinville, SC, Brazil, 89202-050
Sao Jose Do Rio Preto, SC, Brazil, 15090-000
Botucatu, SP, Brazil, 18600-400
Campinas, SP, Brazil, 13060-803
Campinas, SP, Brazil, 13026-210
Santos, SP, Brazil, 11015470
Sao Paulo, SP, Brazil, 04266-010
Sao Paulo, SP, Brazil, 04119-001
Sao Paulo, SP, Brazil, 04040-003
Sorocaba, SP, Brazil, 18047-600
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01447420     History of Changes
Other Study ID Numbers: ML25592
Study First Received: October 4, 2011
Last Updated: July 7, 2014
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014