A randomized, double-blind, placebo-controlled trial of the efficacy and safety of DEB025/Alisporivir in combination with standard of care in hepatitis C genotype 1 treatmentnaïve patients

• Conditions: hepatitis C; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-022867-37-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1040

Inclusion Criteria

Eligible patients have to fulfill all of the following criteria: 1. Written informed consent obtained before performance of any study-related assessment; 2. Males or females aged =18 and = 70 years; 3. Body Mass Index = 18 and = 36 kg/m2; 4. Chronic hepatitis C virus infection diagnosed : • Positive for anti-HCV antibody, or HCV RNA or an HCV genotype test at least 6 months before screening, with positive HCV RNA and anti-HCV antibody tested at the time of screening, OR • Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy within 3 years before randomization, consistent with chronicity of HCV infection (presence of fibrosis); 5. Serum HCV RNA = 1000 IU/ml (3 log10) assessed by qPCR (quantitative polymerase chain reaction) or equivalent, no upper limit; 6. Infection with HCV genotype 1; mixed infections with other genotypes will not be eligible; 7. No previous treatment for Hepatitis C virus infection – i.e. HCV treatment naïve; 8. One of the following liver evaluation: • A liver biopsy within 3 years prior to baseline. If cirrhosis has been previously diagnosed with a biopsy there is no need to repeat the biopsy. • Transient elastography (FibroScan) within 6 months prior to baseline. 9. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception to be eligible. The contraceptive regimen must be maintained during the treatment period and for 7 months after the last DEB025 or RBV dose. Highly effective contraception is defined as either: 1. Total abstinence: When this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 2. Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment 3. Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study subjects, the vasectomised male partner should be the sole partner for that patient. 4. Use of a combination of two of the following methods (a+b during treatment, a+b or a+c or b+c after discontinuation of DEB025): a. Placement of - an intrauterine device (IUD) or - an intrauterine system (IUS) b. Barrier methods of contraception: - Condom with spermicide or - Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository - c. Only 4 weeks after permanent discontinuation of DEB02/placebo: Use of oral, injected or implanted hormonal methods of contraception. Women are considered not to be of child bearing potential (thus eligible without contraception) if they: • are post menopausal as defined as at least 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms), or PLEASE SEE PROTOCOL
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1040
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients fulfilling any of the following criteria are not eligible for inclusion into this study: 1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of that medication before enrollment, whichever is longer; 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes; 3. Any medical contraindications to peg-IFNa and/or RBV treatment; 4. Active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2 years; 5. HBsAg positive; 6. HIV positive; 7. Elevated (>ULN) total bilirubin level documented on more than one (>1) occasion during the past 6 months 8. Documented history of Gilbert’s disease 9. Presence or history of hepatic decompensation, defined by any of the following: • Grade 3 or 4 esophageal or gastric varices, history of upper gastrointestinal bleeding or patients needing primary prophylaxis for varices bleeding • Ascites • Signs of hepatic encephalopathy • Serum albumin < 35 g/L • Prolonged prothrombin time expressed as international normalized ratio (INR) > 1.5 10. Hepatocellular carcinoma (HCC): • Patients with an alpha-fetoprotein (AFP) level = 5 × ULN are excluded. • A liver imaging assessment not older than 2 months prior to the screening visit, with no evidence for focal lesion(s) suggestive of hepatocellular carcinoma is required. Patients with cirrhosis on biopsy or an elasticity score = 14.8 kPa on FibroScan or an elevated AFP (> ULN) must have either a liver ultrasound with contrast medium, a computed tomographic (CT) scan, or magnetic resonance imaging (MRI) to exclude HCC. • For all other patients a conventional liver ultrasound may be performed to exclude HCC. 11. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) either at screening or baseline; 12. Men whose female partners are pregnant or intends to become pregnant while the male patient is receiving study treatment or within 7 months of the last DEB025 or RBV dose.; 13. Men UNLESS they are using a condom with spermicide during intercourse while on treatment and for 7 months after the last DEB025 or RBV dose. Male patients should not father a child in this period. 14. Use of any other medication (including over the counter medication and herbal products) within 30 days before baseline or within 5 drug half-lives of that medication (whichever is longer) that are known inhibitors/inducers of cytochrome 450 3A, substrates of cytochrome 450 3A, substrates of P-gp, or substrates/inhibitors of OATPs, MRP2 or BSEP, or are mentioned in the list of; prohibited medications PLEASE SEE PROTOCOL

Study & Design

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