Trial of Pegasys® in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00245414
First received: October 27, 2005
Last updated: November 16, 2010
Last verified: November 2010

October 27, 2005
November 16, 2010
October 2005
July 2010   (final data collection date for primary outcome measure)
Sustained viral response as undetectable level of HCV-RNA [ Time Frame: week 24 from the end of treatment ] [ Designated as safety issue: No ]
Sustained viral response as undetectable level of HCV-RNA on 24 weeks after the end of treatment.
Complete list of historical versions of study NCT00245414 on ClinicalTrials.gov Archive Site
  • Biochemical response as normal level of ALT [ Time Frame: week 24 from the end of treatment ] [ Designated as safety issue: No ]
  • Viral response as undetectable level of HCV-RNA [ Time Frame: at the end of treatment ] [ Designated as safety issue: No ]
  • 1) Biochemical response as normal level of ALT on 24 weeks after the end of treatment
  • 2) Viral response as undetectable level of HCV-RNA at the end of treatment
Not Provided
Not Provided
 
Trial of Pegasys® in Patients With Chronic Hepatitis C
Post-marketing Clinical Trial of Pegasys® 180μg for Subcutaneous Injection in Patients With Chronic Hepatitis C. General Clinical Study in Interferon (IFN)-Treated and IFN-untreated Chronic Hepatitis C Patients, Except for Those Infected With High Viral Load of Genotype 1b

The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high viral load (≥ 100 KIU/mL).

In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic hepatitis C patients.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Pegasys®
    180μg for s.c./week for 48 weeks
  • Drug: Pegasys®
    180μg for s.c./week for 24 weeks
  • Experimental: 1
    Interferon (IFN)-Treated
    Intervention: Drug: Pegasys®
  • Experimental: 2
    Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1
    Intervention: Drug: Pegasys®
  • Experimental: 3
    Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
    Intervention: Drug: Pegasys®
  • Experimental: 4
    Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
    Intervention: Drug: Pegasys®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Quantitative serum HCV-RNA is positive except for high viral load of genotype 1b (≥ 100 KIU/mL)
  • Observation of serum ALT elevation above upper limit of normal
  • Chronic hepatitis is evaluated as the negative result (< 0) calculated by the method of "formula for discrimination between chronic hepatitis and liver cirrhosis."

Exclusion Criteria:

  • Observation of white blood cells ≦ 3000/mm3; neutrophils ≦ 1500/mm3; platelets ≦ 90,000/mm3; or hemoglobin ≦ 10 g/dL.
  • Observation of the following situations and disease: severe renal disease, hepatitis B co-infection, de-compensated liver disease, liver cirrhosis, hepatocellular carcinoma, poorly controlled psychiatric disease, seizure disorders, immunologically mediated disease, severe cardiac disease, poorly uncontrolled hypertension, poorly controlled diabetes, chronic pulmonary disease, retinopathy, malignant tumor, and organ transplant
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00245414
ML18501
No
Chugai Pharmaceutical
Chugai Pharmaceutical
Not Provided
Study Director: Ken Kashima Chugai Pharmaceutical
Chugai Pharmaceutical
November 2010

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