Chronic Hepatitis C MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Maviret
Product Name: Maviret
Product Code: J05AX
Pharmaceutical Form: Tablet
INN or Proposed INN: GLECAPREVIR
Other descriptive name: Maviret
Concentration unit: mg milligram(s)
Concentra
Sponsors
Department of infectious Diseases, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Chronic hepatitis C defined as two positive HCV tests >6 month apart. First test can be anti-HCV, second test must be HCV-RNA • Age 18-49 • Liver biopsy with F0 or F1 (Metavir score) with in a year of screening. If no liverbiopsy available, a Fibroscan =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Risk of noncompliance • Clinical signs of cirrhosis (liver biopsy not required), or cirrhosis suspected by blood tests. (INR >1,3 or platelets <130*109/L) • Contraindication to treatment with study drugs o Pregnancy o Breastfeeding o Refusal to use contraceptives o Allergy to study drug or components. • Hemoglobin <7.0 mmol/l • Severe cardiac or pulmonary disease where anemia could be a significant problem • Receiving medication that have important interactions with study drugs • Significant liver disease • Renal impairment (eGFR<60ml/min) • Unable to understand Danish • Co-infection with Hepatitis B or HIV • Any other significant clinical illness deemed to interfere with response to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): HCV RNA in serum measured by PCR by intention to treat (ITT) analysis;Timepoint(s) of evaluation of this end point: at 12 weeks post treatment ;Main Objective: To compare the percentage of subjects achieving a 12-week sustained virological response, SVR 12 (HCV RNA below lower limit of quantification at week 12 after end of treatment) after 4 weeks of treatment (including forward moving arm from phase 1) compared to 8 weeks of treatment in the intention to treat population including all subjects taking at least one dose of study medication.;Secondary Objective: To compare the percentage of subjects achieving a 12 week sustained virological response after 4 weeks of treatment with glecaprevir/pibrentasvir with or without ribavirin (phase 1 patients). Porportion of patients achieving SVR12 by ITT analysis for patients in Phase 1. To compare the percentage of subjects achieving SVR 12 after 4 weeks of treatment (including forward moving arm from phase 1) compared to 8 weeks of treatment in the per protocol population To compare the percentage of subjects achieving a 24-week sustained virological response, SVR 24 after 4 weeks of treatment (including forward moving arm from phase 1) compared to 8 weeks of treatment in the intention to treat population and per protocol population Difference in patient related outcomes between treatment arms at treatment week 2 and 4 or 8 and at post treatment week 4, 12, 24 and 48. Difference in hemoglobin levels between treatment arms at treatment week 2 and 4 and at post treatment week 4 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HCV RNA in serum measured by PCR by intention to treat (PP) analysis HCV RNA in serum measured by PCR by intention to treat (ITT) analysis(24 weeks Patient related outcomes as measured by SF-36v2, FSS and ISI at treatment week 2 and 4 or 8 and at post treatment week 4, 12, 24 and 48. Hemoglobin measured in serum at treatment week 2 and 4 and at post treatment week 4 and 12;Timepoint(s) of evaluation of this end point: at 12 weeks post treatment for PP at 24 weeks post treatment for ITT and PP Patient related outcomes as measured by SF-36v2, FSS and ISI at treatment week 2 and 4 or 8 and at post treatment week 4, 12, 24 and 48. | — |
Countries
Denmark
Contacts
Public ContactDeparment of infectious Diseases
Odense University Hospital
Outcome results
None listed