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NCT Number: NCT01429792

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)

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haemek Hospital; Gastroenterology, Afula, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

standard treatment, subcutaneously weekly

ribavirin [Copegus]

Drug

standard treatment, orally daily

Primary outcomes

  1. Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment

    Time frame: Week 12

    The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.

  2. Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment

    Time frame: Week 12

    The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment

  3. Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24

    Time frame: Week 24

    The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment

  4. Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

    Time frame: Week 4

    The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.

  5. Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment

    Time frame: Week 4

    The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.

  6. Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24

    Time frame: Week 24

    The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.

Secondary outcomes

  1. Percentage of Participants With pEVR to Study Treatment at Week 12

    Time frame: Week 12

    The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.

  2. Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment

    Time frame: Week 12

    The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.

  3. Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24

    Time frame: Week 24

    The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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)

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 7, 2011
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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