chronic hepatitis C infection MedDRA version: 11.0 Level: LLT Classification code 10008912 Term:
Conditions
Interventions
Product Name: Debio 025
Pharmaceutical Form: Capsule, soft
CAS Number: 25443509505
Current Sponsor code: Debio 025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
Debiopharm S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females aged =18 and =65 years; 2. BMI between =18 and = 32 kg/m2; 3. HbsAg negative and HIV-1 negative; 4. Serological diagnosis of chronic hepatitis C viral infection genotype 1 for > 6 months; 5. Chronic liver disease consistent with chronic hepatitis C infection on a biopsy or FibroScan® obtained within the past 24 months (36 months for patients with incomplete/transition to cirrhosis) 6. Previously untreated for HCV infection (approved or investigational drug); 7. Plasma HCV RNA level lower limit =100 IU/ml assessed by qPCR or equivalent; no upper limit; 8. Neutrophil count =1500/µL; Hb =12g/dL for females and =13g/dL for males; platelets = 90 000/µL 9. Patients with incomplete/transition to cirrhosis must have an US, CT scan, or MRI scan without evidence of hepatocellular carcinoma (within 2 months prior to randomization) and a serum AFP 50 mL/min; 13. TSH within normal range; 14. All patients should be advised on Debio 025 and ribavirin foetotoxicity: a. Females may participate if they are surgically sterile or post-menopausal. Pre-menopausal females may participate if they use 2 reliable contraceptive methods (oral contraceptive + barrier method). The contraceptive regimen must be maintained during the treatment period and for 4 months after the last Debio 025 or ribavirin dose. b. Male patients must be surgically sterile or use 2 reliable contraceptive methods (oral contraceptive + barrier method). The contraceptive regimen must be maintained during the treatment period and for 7 months after the last Debio 025 or ribavirin dose. 15. Signed informed consent before any study procedures; 16. Negative pregnancy test within one week of first investigational product administration for female patients of child bearing potential. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with any investigational drug within 6 months prior to the first dose of investigational product; 2. HCV genotype different from genotype 1; 3. Any previous HCV treatment (approved or investigational); 4. Histologic evidence of complete hepatic cirrhosis (including compensated cirrhosis) based on a previous liver biopsy (if available); 5. Ongoing or recent use of any other medication (including over the counter medication and herbal products) within 2 weeks before study start or within 5 drug half-lives of that medication (whichever is longer) that are known inhibitors/inducers of CYP450 3A, substrates of P-gP, or substrates/inhibitors of OATPs, MRP2, or BSEP and are mentioned in the list of unauthorised medications; 6. Any medical contraindications to peg-IFNa2a and/or ribavirin treatment; 7. Any other cause of relevant liver disease other than HCV including but not limited to HBV, drug- or alcohol-related cirrhosis, autoimmune hepatitis, haemochromatosis, Wilson’s disease, NASH, PSC, or PBC; 8. Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment or could interfere with the patient participating in and completing the study. Patients with risk factors (hypertension or diabetes) need to have an ophthalmologic investigation (including fundoscopy) 9. History of moderate, severe, or uncontrolled psychiatric disease, especially depression, including a history of hospitalisation or prior suicidal attempt; 10. Uncontrolled arterial hypertension, i.e. patients with systolic BP =160 mmHg and/or diastolic BP =100 mmHg; 11. History of pancreatitis, uncontrolled diabetes mellitus or retinopathy; 12. ANA titre >1:640 at screening and/or evidence of autoimmune hepatitis on liver biopsy; 13. Alcohol consumption > 20 g/day for females and > 30 g/day for males; 14. History of major organ transplantation with an existing functional graft; 15. Pregnancy or lactation; 16. Haemoglobinopathies (thalassaemia major, sickle cell anaemia or drepanocytosis); 17. Familial history of severe neonatal cholestasis or pregnancy cholestasis; 18. Evidence of an active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Proportion of patients achieving SVR 24 (HCV RNA < 10 IU/mL 24 weeks after treatment end). ;Main Objective: To evaluate whether 48-week triple therapy peg-IFNa2a 180 µg once weekly + ribavirin 1000 or 1200 mg/day + Debio 025 600 mg significantly increases the proportion of patients who achieve SVR (HCV RNA < 10 IU/mL 24 weeks after treatment end) compared with standard 48-week peg IFNa2a 180 µg once weekly + ribavirin 1000 or 1200 mg/day therapy (SOC) in treatment naïve chronic hepatitis C genotype 1 patients. ;Secondary Objective: 1. To evaluate whether 24-week triple therapy peg-IFNa2a 180 µg once weekly + ribavirin 1000 or 1200 mg/day + Debio 025 600 mg significantly increases the proportion of patients who achieve SVR 24 (HCV RNA < 10 IU/mL 24 weeks after treatment end) compared to SOC treatment. 2. To evaluate whether the 24-/48-week response-guided triple therapy peg-IFNa2a 180 µg once weekly + ribavirin 1000 or 1200 mg/day + Debio 025 600 mg significantly increases the proportion of patients who achieve SVR 24 (HCV RNA < 10 IU/mL 24 weeks after treatment end) compared to SOC treatment. 3. To evaluate whether any of the different peg-IFNa2a 180 µg once weekly + ribavirin 1000 or 1200 mg/day + Debio 025 600 mg triple therapies significantly increases the proportion of patients who achieve SVR 12 (HCV RNA < 10 IU/mL 12 weeks after treatment end) compared to SOC treatment. | — |
Countries
Belgium, France, Germany, Italy, Poland, Spain
Outcome results
None listed