treatment na ve patients with chronic hepatitis C MedDRA version: 8.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Interventions
Product Name: DEBIO-025
Pharmaceutical Form: Oral solution
INN or Proposed INN: VARI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the
Sponsors
DEBIOPHARM S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Male or female patients 2 Age 8805;18 years and 8804;70 years; 3 Weight 8805;50 kg for women and 8805;60 kg for men; 4 Body mass index BMI between 8805;18 and 8804;29 5 HBs-Ag negative, HIV negative 6 Plasma HCV lower limit 8805;1000 IU/mL, no upper limit 7 Patients must be anti-HCV treatment na ve 8 White blood cell count 8805;3000/ L, Neutrophil count 8805;1500/ L, Hemoglobin 8805;100g/L, Platelets 8805;150 000/ L 9 Normal or compensated liver function as documented by the following a No history of esophageal varices bleeding, absence on physical examination of signs compatible with decompensated liver disease, such as ascites, jaundice, hepatic encephalopathy. b Albumin 8805; 35 g/L c Total Bilirubin 8804;1.2 mg/dL 8804;20 mol/L d Prothrombin INR 8804;1.2 e Aspartate aminotransferase ASAT , alanine aminotransferase ALAT 8804; 6 times the upper limit of normal ULN 10 All patients should be advised on the possible effects on foetotoxicity of DEBIO-025 and therefore restrain from reproductive activity a Females may participate if they are surgically sterile or postmenopausal. Pre-menopausal women may participate if they are abstinent or are compliant with a reliable contraceptive regimen. Abstinence or contraceptive regimen must be maintained during the treatment period and for 8 weeks after discontinuation of therapy. b Male patients must be surgically sterile, abstinent, or utilizing a barrier contraceptive method. Abstinence or contraceptive regimen must be maintained during the treatment period and for 8 weeks after discontinuation of therapy. 11 Signed informed consent before entry into the study 12 Negative pregnancy test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Ongoing or recent use of any anti-viral medication within one month before study start or within five drug half-lives of the investigational drug whichever is the longer 2 Ongoing or recent use of any other medication within 2 weeks before study start or within five drug half-lives of the investigational drug whichever is the longer 3 Presence of any severe concomitant disease cardiac, respiratory, gastrointestinal, renal, neurologic, psychiatric, infectious, bone, endocrine 4 For patients having in their previous history a documented liver biopsy, the presence of advanced inflammation, necrosis and fibrosis as expressed by one of the validated grading histology scores e.g. Scheuer Grade 4 for Necroinflammation and Fibrosis, Metavir Score A3F3 or superior, or equivalent score 5 Ultrasound or CT or MRI findings at screening with evidence of liver carcinoma or advanced liver fibrosis or biliary disease 6 Alfa fetoprotein exceeding 50 ng/mL; patients with values 20-50 ng/mL should have appropriate exclusion of liver carcinoma by US, CT or MR imaging 7 Arterial hypertension, i.e. patients with systolic blood pressure 8805;160 mmHg and/or diastolic blood pressure 8805;100 mmHg 8 Significant kidney impairment serum creatinine 8805; 2 times the ULN 9 Liver transplant recipient 10 Any concomitant disorder or resultant therapy that is likely to interfere with patient compliance or with the study procedures 11 Participation in another study with an experimental drug within three months before study start or within five drug half-lives of the investigational drug whichever is the longer 12 Known hypersensitivity to any of the test materials or related compounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the minimum effective dose MED of DEBIO-025 in a 4 week treatment course of daily oral DEBIO-025 combined with once weekly 180 g PEGASYS pegylated interferon alfa-2a injections in chronically HCV infected treatment na ve patients that shows an additive anti-HCV effect when compared to PEGASYS 180 g weekly monotherapy.;Secondary Objective: To demonstrate that an effective and well tolerated dose of oral DEBIO-025 combined with 180 g weekly PEGASYS has an additive effect on HCV viral load reduction compared to the same dose of DEBIO-025 monotherapy. To evaluate the safety of the daily oral DEBIO-025 and weekly injected 180 g PEGASYS combination therapy. To establish in a subset of patients at least n 6/treatment group, minimum total 30 patients the pharmacokinetic PK profile of DEBIO-025 and PEGASYS as single agents and in combination to explore potential drug interactions.;Primary end point(s): - Maximum log10 viral load reduction HCV RNA IU/mL from pre-treatment Day 1 to any on-treatment Day 2 to Day 29 or post-treatment value Day 30 to Day 50. -Incidence of adverse events, change in vital signs, haematology, coagulation, biochemistry, urinalysis, 12-lead ECG parameters RR, PR, QRS, QT, and QTCB intervals . | — |
Countries
Italy
Outcome results
None listed