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    Summary
    EudraCT Number:2006-002695-17
    Sponsor's Protocol Code Number:DEB-025-HCV-203
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-002695-17
    A.3Full title of the trial
    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
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberDEB-025-HCV-203
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDEBIOPHARM S.A.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDEBIO-025
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVARI
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name PEGASYS*SC SIR 0,5ML 180MCG+AG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 76543-88-9
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    treatment na ve patients with chronic hepatitis C
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal 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.
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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 .
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 90
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
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