A Phase 4 interventional study of Abbreviation of treatment duration in HBV/HCV Co-infection, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-15.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Phase 4, Interventional, and Treatment
This is an open label, randomized-controlled, comparative trial. HBV and HCV dually infected patients with negative hepatitis B e antigen (HBeAg) were enrolled in the study. The definition of HBV and HCV dual infection included seropositivity of HCV antibody (anti-HCV) and HBsAg for more than 6 months, together with positive serum HCV RNA. Eligible subjects were randomized into 2 groups at treatment initiation. Subjects who were randomized into the genotype guided therapy (GGT) group received Peg-IFN and standard dose RBV (1200 mg/day) for 48 weeks in subjects infected with HCV genotype 1 or Peg-IFN and low dose RBV (800 mg/day) for 24 weeks in subjects infected with HCV genotype 2/3; the patients were then followed for 6 months. For subjects who were randomized into the response guided therapy (RGT) group, the duration of Peg-IFN and RBV therapy was abbreviated to 24 weeks in subjects with HCV genotype 1, a pre-treatment low viral load (LVL, \< 400000 IU/mL) and RVR (defined asHCV RNA \<50 IU/mL at 4th week of therapy); the duration was 16 weeks in subjects with HCV genotype 2/3 and RVR.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 203 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
For subjects who were randomized into the RGT group, the duration of Peg-IFN and RBV therapy was abbreviated to 24 weeks in subjects with HCV genotype 1, a pre-treatment low viral load (LVL, \< 400000 IU/mL) and RVR (defined asHCV RNA \<50 IU/mL at 4th week of therapy); the duration was 16 weeks in subjects with HCV genotype 2/3 and RVR.
Other: Abbreviation of treatment duration
Subjects who were randomized into the GGT group received Peg-IFN and standard dose RBV (1200 mg/day) for 48 weeks in subjects infected with HCV genotype 1 or Peg-IFN and low dose RBV (800 mg/day) for 24 weeks in subjects infected with HCV genotype 2/3; the patients were then followed for 6 months.
Other: Abbreviation of treatment duration
Rate of HCV sustained virological response
Time frame: 6 months after completion of therapy
No study locations are listed for this record.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Kaohsiung Medical University Chung-Ho Memorial Hospital