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NCT Number: NCT00304551

A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.

Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chugoku, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.

Exclusion criteria

  • Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
  • Thrombocytopenia (fewer than 75,000 platelets per cubic millimeter)
  • Anemia (less than 12 g hemoglobin per deciliter )
  • Hepatitis B co-infection; decompensated liver disease.
  • Organ transplant
  • Creatinine clearance less than 50 milliliters per minute
  • Poorly controlled psychiatric disease
  • Poorly controlled diabetes
  • Malignant neoplastic disease
  • Severe cardiac or chronic pulmonary disease
  • Immunologically mediated disease
  • Retinopathy

Treatment and study plan

peginterferon alfa-2a 180μg

Drug

180μg（s.c.）/week for 48 weeks

peginterferon alfa-2a 90μg

Drug

90μg(s.c.)/week for 48 weeks

Ribavirin

Drug

600, 800, or 1,000 mg X 2(p.o.)/day

Primary outcomes

  1. Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])

    Time frame: week 24 from the end of treatment

Secondary outcomes

  1. Biochemical response (normalization of serum alanine aminotransferase activity)

    Time frame: at the end of treatment and week 24 form the end of treatment

  2. Virological response (HCV-RNA < 50 IU per milliliter)

    Time frame: at the end of treatment and week 24 form the end of treatment

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Mar 20, 2006
Registry last updated
Jun 3, 2010

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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