Trial of Pegasys® in Patients With Chronic Hepatitis C

NCT00245414 | Completed Phase 4

• 1 other identifier: ML18501
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained viral response as undetectable level of HCV-RNA

  week 24 from the end of treatment

Secondary Outcomes (2)

• Biochemical response as normal level of ALT

  week 24 from the end of treatment

• Viral response as undetectable level of HCV-RNA

  at the end of treatment

Study Arms (4)

1

EXPERIMENTAL

Interferon (IFN)-Treated

Drug: Pegasys®

2

EXPERIMENTAL

Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1

Drug: Pegasys®

3

EXPERIMENTAL

Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1

Drug: Pegasys®

4

EXPERIMENTAL

Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1

Drug: Pegasys®

Interventions

Pegasys® DRUG

180μg for s.c./week for 48 weeks

1; 2; 3

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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."

You may not qualify if:

• 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

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (6)

Kyusyu Region

Fukuoka, Japan

Location

Chugoku Region

Okayama, Japan

Location

Kinki Region

Osaka, Japan

Location

Hokkaido Region

Sapporo, Japan

Location

Kanto Region

Tokyo, Japan

Location

Tokai Region

Yamanashi, Japan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

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

Study Officials

• Ken Kashima

  Chugai Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 28, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 17, 2010

Record last verified: 2010-11

Locations

JP (6)