A multi-centre, randomised, double-blind, placebo-controlled escalating dose ranging phase II study on the efficacy of DEBIO-025 to reduce HCV viral load in combination with PEGASYS 180 g/week in treatment na ve patients with chronic hepatitis C and on the safety of this combination therapy - ND

• Conditions: treatment na ve patients with chronic hepatitis C; MedDRA version: 8.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2006-002695-17-IT
• Lead Sponsor: DEBIOPHARM S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified