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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
Sponsor:
Information provided by:
Kyushu University
ClinicalTrials.gov Identifier:
NCT00956982
First received: August 6, 2009
Last updated: August 10, 2009
Last verified: August 2009
History of Changes

August 6, 2009
August 10, 2009
December 2004
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00956982 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C

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).
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C Virus
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1251
December 2012
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Jun Hayashi +81-92-642-5909 hayashij@genmedpr.med.kyushu-u.ac.jp
Japan
 
NCT00956982
KULDS2009
Yes
Jun Hayashi, Department of General Medicine, Kyushu University Hospital
Kyushu University
Not Provided
Principal Investigator: Jun Hayashi Department of General Medicine, Kyushu University Hospital
Kyushu University
August 2009

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