PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Kyushu University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kyushu University
Information provided by:
Kyushu University
ClinicalTrials.gov Identifier:
NCT00956982
First received: August 6, 2009
Last updated: August 10, 2009
Last verified: August 2009
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Purpose
The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old).
| Condition | Intervention |
|---|---|
|
Hepatitis C Virus |
Drug: Pegylated interferon alpha-2b plus ribavirin |
| 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: | Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C |
Resource links provided by NLM:
Drug Information available for:
Interferon
Ribavirin
Interferon Alfa-2a
Interferon Alfa-2b
Peginterferon Alfa-2b
U.S. FDA Resources
Further study details as provided by Kyushu University:
Primary Outcome Measures:
- antiviral effect by PEG-IFN alpha-2b plus RBV treatment [ Time Frame: 24-weeks follow-up after the end of treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment [ Time Frame: during PEG-IFN alpha-2b plus RBV treatment (48 weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1251 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Pegylated interferon alpha-2b plus ribavirin
All patients were treated with a weight-based, 1.5 μg/kg weekly dose of subcutaneous PEG-IFN alpha-2b (PegIntron A, Schering-Plough, Osaka, Japan), in combination with PEG-IFN alpha-2b, RBV (Rebetol; Schering-Plough), which was given orally at a daily dose of 600-1000mg based on bodyweight (600 mg for patients weighing < 60 kg, 800 mg for those weighing 60-80 kg, and 1000 mg for those weighing 80 kg). The length of treatment was 48 weeks for patients with HCV of genotype 1and 24 weeks for patients with genotypes 2, respectively
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.
- All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.
Exclusion Criteria:
- Clinical or biochemical evidence of hepatic decompensation.
- Advanced cirrhosis identified by large esophageal varices (F2 or F3).
- History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.
- Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ.
- Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).
- Excessive active alcohol consumption > 60 g/day or drug abuse.
- Severe psychiatric disease.
- Antiviral or corticosteroid therapy within 12 months prior to the enrollment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956982
Contacts
| Contact: Jun Hayashi | +81-92-642-5909 | hayashij@genmedpr.med.kyushu-u.ac.jp |
Locations
| Japan | |
| Department of General Medicine, Kyushu University Hospital | Recruiting |
| Fukuoka, Japan, 812-8582 | |
| Contact: Mosaburo Kainuma +81-92-642-5909 kainuma@genmedpr.med.kyushu-u.ac.jp | |
| Principal Investigator: Jun Hayashi | |
Sponsors and Collaborators
Kyushu University
Investigators
| Principal Investigator: | Jun Hayashi | Department of General Medicine, Kyushu University Hospital |
More Information
No publications provided
| Responsible Party: | Jun Hayashi, Department of General Medicine, Kyushu University Hospital |
| ClinicalTrials.gov Identifier: | NCT00956982 History of Changes |
| Other Study ID Numbers: | KULDS2009 |
| Study First Received: | August 6, 2009 |
| Last Updated: | August 10, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Kyushu University:
|
Hepatitis C Virus Pegylated Interferon Ribavirin Older |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic Interferon-alpha Interferon Alfa-2a |
Interferon Alfa-2b Interferons Ribavirin Peginterferon alfa-2b Reaferon Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013