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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
 Drug: Pegasys®
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Sustained viral response as undetectable level of HCV-RNA [ Time Frame: week 24 from the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 108
Study Start Date: October 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Interferon (IFN)-Treated
 Drug: Pegasys®
180μg for s.c./week for 48 weeks
Experimental: 2
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1
 Drug: Pegasys®
180μg for s.c./week for 48 weeks
Experimental: 3
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
 Drug: Pegasys®
180μg for s.c./week for 48 weeks
Experimental: 4
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
 Drug: Pegasys®
180μg for s.c./week for 24 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245414

Locations
Japan
Kyusyu Region
Fukuoka, Japan
Chugoku Region
Okayama, Japan
Kinki Region
Osaka, Japan
Hokkaido Region
Sapporo, Japan
Kanto Region
Tokyo, Japan
Tokai Region
Yamanashi, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Ken Kashima Chugai Pharmaceutical
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00245414     History of Changes
Other Study ID Numbers: ML18501
Study First Received: October 27, 2005
Last Updated: November 16, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013