A multicentre, randomized, double-blind, placebocontrolled, parallel-group phase II study on the efficacy and safety of DEB025 combined with peg-IFN alfa-2a and ribavirin in chronic hepatitis C genotype 1 patients who are previous peg-IFN alfa-2 plus ribavirin treatment-nonresponders - ND
- Conditions
- chronic hepatitis CMedDRA version: 9.1Level: PTClassification code 10008909MedDRA version: 9.1Level: PTClassification code 10019744
- Registration Number
- EUCTR2010-020033-14-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 258
1. Patients eligible for inclusion in this study have to fulfill all of the following criteria: 2. Written informed consent must be obtained before any assessment is performed. 3. Males or females aged =18 and = 65 years; 4. BMI between = 18 and = 36 kg/m2; 5. HBsAg negative and HIV negative; 6. Chronic hepatitis C viral infection on record and diagnosed by two tests performed at an interval of at least 6 months (the initial diagnosis can be based on positive HCV antibodies or quantitative or qualitative HCV RNA measurement). Furthermore, chronicity needs to be confirmed by a positive HCV RNA test, i.e. qPCR (quantitative polymerase chain reaction); thus the 2nd test may be performed at screening; 7. Plasma HCV RNA level lower limit = 10000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening; no upper limit; 8. HCV genotype 1; 9. Previous non-responders to SOC (with peg-IFNa 2a or 2b and RBV) after full dose treatment for at least 12 weeks with detectable HCV RNA at the end of treatment. A minimum of 3 months must have elapsed since the patient`s last treatment when the patient qualified as a non-responder and recruitment into this study.
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
Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening in the current trial. 2. 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 cytochrome 450 3A, substrates of cytochrome 450 3A, substrates of P-gp, or substrates/inhibitors of OATPs, MRP2 or BSEP, and are mentioned in the list of unauthorized medications. 3. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. Any medical contraindication to treatment with IFN and/or RBV. 4. Patients with evidence of cirrhosis at the time of screening. Confirmation of non-cirrhotic status of a patient needs to be obtained from a liver biopsy result within the past 24 months or by transient elastography (within 6 months prior to screening). Any other means for detection of cirrhosis (e.g. no evidence of portal hypertension) should also be considered to exclude cirrhosis. 5. Active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2 years. Lack of exclusion of hepatocellular carcinoma by any imaging technique within 6 weeks prior to screening and serum Alpha-fetoprotein (AFP) > 100 ng/mL. 6. History of clinical evidence of chronic cardiac disease or ECG with clinically significant abnormalities, such as QTc > 450 msec for males and > 470 msec for females (Fredericia correction) at screening or baseline. Angina pectoris or ischaemic heart disease requiring current medical intervention. 7. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS (1) they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for US only: and estradiol <20 pg/mL], or (2) have passed 6 weeks from surgical bilateral oophorectomy with or without hysterectomy [in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment], or (3) agree to use at least two reliable forms of effective contraception during treatment and during the 7-month post-treatment follow-up period. One method is the male’s use of a condom with spermicide. The other must be one of the following: • Surgical sterilization (e.g., bilateral tubal ligation) • Hormonal contraceptives (any marketed contraceptive agent that includes an estrogen and/or a progestational agent) • Intrauterine device (copper or hormonal) • Diaphragm with spermicide • Sponge 8. Fertile males, defined as all males physiologically capable of conceiving offspring may be enrolled in this study if the patient agrees to use a condom with spermicide and his female partner agrees to use one or more of the acceptable methods of contraception listed above from the date of screening until 7 months after their last dose
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method