Status:
COMPLETED
Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4
Lead Sponsor:
Ain Shams University
Collaborating Sponsors:
Schering-Plough
Fulbright
Conditions:
Hepatitis C
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interfer...
Detailed Description
Hepatitis C virus (HCV) genotype 4 is the most frequent cause of chronic hepatitis C in Middle East, North Africa and sub-Saharan Africa. In countries like Egypt, 73 to 90% of cases of chronic hepatit...
Eligibility Criteria
Inclusion
- Adult males and females, 18 to 50 years of age; with documented chronic hepatitis C according to the following criteria: elevated serum alanine aminotransferase (ALT) above the upper limit of normal (40 U/l) on two occasions during the preceding six months; anti-HCV positive anti-body status assessed by second generation enzyme linked immunosorbent assay (Roche Diagnostics, Branchburg, New Jersey, USA); positive polymerase chain reaction for HCV RNA (Cobas Amplicor HCV Monitor v2.0; lower limit of quantitation 50 IU/mL); genotype 4; and criteria for chronic hepatitis C in liver biopsy performed within the preceding year with no signs of cirrhosis or bridging fibrosis on pretreatment liver biopsy.
- \-
Exclusion
- Previous IFN-alpha therapy; other liver diseases such as hepatitis A, hepatitis B, schistosomiasis, autoimmune hepatitis, alcoholic liver disease, drug induced hepatitis, or decompensated liver disease; coinfection with schistosomiasis or human immunodeficiency virus; neutro¬penia (,1 500/mm3); thrombocytopenia (,90 000/mm3); creatinine concentration .1.5 times the upper limit of normal; serum a fetoprotein concentration .25 ng/ml; organ transplant; neoplastic disease; severe cardiac or pulmonary disease; unstable thyroid dysfunction; psychiatric disorder; current pregnancy or breast feeding; or therapy with immunomodulatory agents within the last six months.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00277862
Start Date
April 1 2002
End Date
April 1 2007
Last Update
February 26 2008
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
AUS Specialized Hospital,
Cairo, Cairo Governorate, Egypt, 11351,
2
DIACSERA
Cairo, Egypt
3
MISR Welding
Cairo, Egypt
4
ELectricity Auth
Mynia and Cairo, Egypt