A Pilot Study To Evaluate the Efficacy of Response Guided Therapy of Peginterferon Alfa Plus Ribavirin in the Treatment of Patients With HCV/HBV Co-Infection

NCT ID: NCT02339337

Last Updated: 2015-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30

Brief Summary

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.

Conditions

HBV/HCV Co-infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RGT group

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.

Group Type: EXPERIMENTAL

Abbreviation of treatment duration

Intervention Type: OTHER

GGT group

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.

Group Type: ACTIVE_COMPARATOR

Abbreviation of treatment duration

Intervention Type: OTHER

Interventions

Abbreviation of treatment duration

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• seropositivity of HCV antibody (anti-HCV) and HBsAg for more than 6 months, together with positive serum HCV RNA.
• negative HBeAg
• serum alanine aminotransferase (ALT) levels between 1-10-fold of the upper limit of normal (ULN)
• treatment naive or had previously failed interferon monotherapy.

Exclusion Criteria

• decompensated liver disease (Child-Pugh score ≥ 7)
• Pregnant or breast-feeding women
• serum creatinine ≥ 2 mg/dL
• evidence of alcoholism or drug abuse
• any other known disease that was not suitable for Peg-IFN therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KMUH-IRB-980019

Identifier Type: -

Identifier Source: org_study_id