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NCT Number: NCT01033448

A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

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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
  • Chronic hepatitis C, genotype 1, 2, 3
  • Compensated liver disease
  • Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders

Exclusion criteria

  • Decompensated liver disease
  • Signs or symptoms of hepatocellular carcinoma
  • Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus

Treatment and study plan

Copegus

Drug

COPEGUS 800 mg or 1000-1200 mg po for 24 weeks

peginterferon alfa-2a [Pegasys]

Drug

PEGASYS 180 micrograms sc once weekly for 24 weeks

Primary outcomes

  1. End of Treatment Response Rate at Week 72 in Genotype 1

    Time frame: Week 72

    End of treatment response rate at Week 72 was reported for genotype 1.

  2. End of Treatment Response in Genotype 2 and 3

    Time frame: Week 48

    End of treatment response rate at Week 48 was reported for genotype 2 and 3.

  3. Sustained Viral Response (SVR) Rates in CHC Genotype 1

    Time frame: Week 96

    Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.

  4. SVR Rates in Genotype 2 and 3.

    Time frame: Week 72

    Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.

Secondary outcomes

  1. Percentage of Participants With Adverse Event (AE)

    Time frame: Week 96

    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 16, 2009
Registry last updated
Oct 3, 2017

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

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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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