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

HBV/HCV Co-infection Clinical Trial

Official title:

A Randomized-Controlled, Comparative Study, To Evaluate the Efficacy of Tailored Regimen of Peginterferon Alfa Plus Ribavirin According to Rapid Virological Response and Baseline Viral Loads in the Treatment of Patients With Chronic Hepatitis C/Hepatitis B Co-Infection: A Pilot Study (Pioneer)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339337
• Other study ID #: KMUH-IRB-980019
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2015
• Last updated: January 12, 2015
• Start date: June 2010

Study information

• Verified date: January 2015
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coinfection
• HBV/HCV Co-infection
• Infection

Intervention

Other:
• Abbreviation of treatment duration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of HCV sustained virological response		6 months after completion of therapy	No