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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00304551
First received: March 5, 2006
Last updated: June 1, 2010
Last verified: June 2010

March 5, 2006
June 1, 2010
June 2006
December 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
Complete list of historical versions of study NCT00304551 on ClinicalTrials.gov Archive Site
  • Biochemical response (normalization of serum alanine aminotransferase activity) [ Time Frame: at the end of treatment and week 24 form the end of treatment ] [ Designated as safety issue: No ]
  • Virological response (HCV-RNA < 50 IU per milliliter) [ Time Frame: at the end of treatment and week 24 form the end of treatment ] [ Designated as safety issue: No ]
  • 1) Biochemical response (normalization of serum alanine aminotransferase activity)
  • 2) Virological response (HCV-RNA <50IU per milliliter) at the end of treatment (week 48).
Not Provided
Not Provided
 
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)
A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Chronic Hepatitis C
  • Drug: peginterferon alfa-2a 180μg
    180μg(s.c.)/week for 48 weeks
  • Drug: peginterferon alfa-2a 90μg
    90μg(s.c.)/week for 48 weeks
  • Drug: ribavirin
    600, 800, or 1,000 mg X 2(p.o.)/day
  • Experimental: 1
    Interventions:
    • Drug: peginterferon alfa-2a 180μg
    • Drug: ribavirin
  • Experimental: 2
    Interventions:
    • Drug: peginterferon alfa-2a 90μg
    • Drug: ribavirin
  • No Intervention: 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
June 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00304551
JV19595
No
Chugai Pharmaceutical
Chugai Pharmaceutical
Not Provided
Study Director: Takehiko Aoshima Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd.
Chugai Pharmaceutical
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP