Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to explore the efficacy and safety of boceprevir -based triple therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Collaborator: National Taiwan University Hospital
• Treatments: Ribavirin

Criteria

Inclusion Criteria:

• 1. Patient must be 20 years or older

• 2. Patient must have HCV GT1 infection combined with HBV infection.

• 3. Patients must be serum HCV RNA detectable, anti-HCV positive, HBsAg positive and HBeAg negative.

• 4. Patient has previously failed treatment with PEG-IFN-α 2a or 2b/RBV for minimum of 12 weeks of treatment.

• 5. Patient must have compensated liver disease consistent with CHC and/or CHB, and no other etiology. Note: patients with cirrhosis should have a liver imaging study (e.g. ultrasound, CT scan or MRI) within the preceding 6 months showing no evidence of hepatocellular carcinoma.

• 6. Patient meets all of the requirements and none of the contra-indications for treatment with PEG-IFN alpha-2b/RBV or boceprevir defined in the labels for the PEG-IFN/RBV to be used in combination with boceprevir.

• 7. Patient is able and willing to provide signed informed consent (prepared by and administered by the physician) as required by local country requirements.

Exclusion Criteria:

• 1. Mixed genotypes including HCV genotype other than genotype 1.

• 2. Patient has received boceprevir, narlaprevir, telaprevir, or any other HCV protease inhibitor treatment.

• 3. Patient has evidence of decompensated liver disease including but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.

• 4. Patient meets any of the following exclusionary hematologic and biochemical criteria (documentation required) Hemoglobin <12 gm/dL for females and <13 gm/dL for males Neutrophils <1500/mm3 Platelets <100,000/mm3

• 5. Patient has an organ transplant other than cornea or hair.

• 6. Patient is co-infected with human immunodeficiency virus (HIV)

• 7. Patient requires or is anticipated to require any of the following prohibited medications: midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives

• 8. Patient with clinical diagnosis or evidence of substance abuse involving alcohol, intravenous drugs, inhalational psychotropics, narcotics, cocaine prescription or over-the-counter drugs.

• 9. Patient previously demonstrated clinically significant hypersensitivity or other contraindication to any component of the boceprevir formulation. This drug contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

• 10. Serious illness, including malignancy, active coronary artery disease or cardiac dysfunction within 24 weeks prior to study entry, that in the opinion of the site investigator may preclude completion of the treatment regimen.

• 11. Major hemoglobinopathy (e.g., thalassemia major), coagulopathy or any other cause of or tendency to hemolysis or bleeding