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    Summary
    EudraCT Number:2008-000495-24
    Sponsor's Protocol Code Number:V-CT-2
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-28
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2008-000495-24
    A.3Full title of the trial
    A Multicenter, Open-Label, Pilot Study to Explore the Safety and Efficacy of Intravenous Bortezomib in Patients with Hepatitis C
    A.3.2Name or abbreviated title of the trial where available
    ViroLogik CT-02
    A.4.1Sponsor's protocol code numberV-CT-2
    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 SponsorViroLogik GmbH
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name VELCADE
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBortezomib
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBortezomib
    D.3.9.1CAS number 179324-69-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.3.11.8Extractive medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    repeated dose treatment with Bortezomib in patients with chronic HCV infection
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002724
    E.1.2Term Anti-HCV positive
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety and tolerability of Bortezomib in patients with HCV infection.
    E.2.2Secondary objectives of the trial
    • To obtain preliminary efficacy data of Bortezomib in patients with chronic HCV infection.
    • To obtain data regarding progression of HCV related liver diseases by Bortezomib in patients with HCV infection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and females aged <18 years
    2. CD4-counts > 250/µl
    3. Documented laboratory diagnosis of HCV infection with detectable viral load
    4. Not tolerating or responding to hepatitis C treatment with interferon and ribavirin
    5. No treatment with a HCV active antiviral therapy such as ribavirin and/or interferon ≤28 days before Baseline
    6. Serum HCV ribonucleic acid (RNA) levels > 100 000 copies/mL
    7. Patients without relevant uncontrolled infections and in good general health
    8. Patients without clinically significant abnormalities at physical examination, vital signs, ECG and laboratory parameters, which may in the judgment of the Investigator/principal Investigator, interfere with the safety of the patient or confound the objectives of the study
    9. Normal renal function defined as renal clearance >= 80 mL/min (according to Cockroft & Gault formula at Screening)
    10. Negative urine pregnancy test (females of childbearing potential only)
    11. Women who are post-menopausal (natural menopause established in retrospect after 12 consecutive months of amenorrhoea without hormone replacement therapy during the last 5 months), surgically sterilized or using a highly effective method of contraception (an implanted or injected hormonal contraceptive, some intrauterine contraceptive devices (IUDs) containing hormones, sexual abstinence, or have a vasectomised partner). Females using combined oral contraceptives should use a different or additional highly effective method of contraception as listed above
    12. Willingness to use highly effective contraception (double barrier method) by both males and females while on study treatment and for 3 months following Bortezomib treatment
    13. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    14. Liver biopsy at any time prior to enrollment with a pathology report confirming the histological diagnosis consistent with chronic hepatitis
    15. HIV test performed at screening day with negative result
    E.4Principal exclusion criteria
    1. Patients with a familiar history of, a known hypersensitivity or multiple allergies toward drugs, especially hypersensitivity to Bortezomib, boron or mannitol
    2. Uncontrolled infection or any chronic infection which requires acute treatment
    3. Patients with clinically significant gastrointestinal, renal, hepatic, respiratory, cardiovascular, metabolic or hormonal disorders
    4. Patient having experienced cerebral seizures in the past
    5. Active or past abnormal function of peripheral nervous system (polyneuropathy)
    6. Patients with a present condition, which may alter the pharmacokinetics of a drug, including but not limited to blockers and inducers of cytochrome P450 3A and 2C19 such as HIV 1 PIs, HIV-1 NNRTIs, rifampicin or carbamazepin.
    7. Renal dysfunction defined as creatinine clearance <80mL/min (acc. to the Cockcroft & Gault formula) at Screening
    8. Hepatic dysfunction defined as follows:
    Alanine aminotransferase (AL(A)T) and aspartate aminotransferase
    AS(A)T) >3 x upper limit of the normal range (ULN)
    Total bilirubin >1.5mg/dL
    9. Abnormal haematologic function (absolute neutrophil count (ANC) <2000/mm3; platelets <150,000/mm3 [±15%] or haemoglobin <12.0g/dL)
    10. Low blood pressure (< 110 mm Hg systolic blood pressure) and patients with history of syncope
    11. Patients receiving ongoing therapy, or therapy within 7 days of study enrolment, with any of the drugs outlined in Section 6.7
    12. Pregnant women or women who are breast-feeding
    13. Positive drug test before administration of study medication for the following: cocaine, amphetamines, opiates, ethanol > 0.5 pro mille
    14. Current alcohol or substance abuse judged by the Investigator to potentially interfere with patient compliance
    15. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements
    16. CD4 counts ≤ 250/µL
    17. Participation in a study of an investigational drug or device concomitantly or within 30 days prior to this study
    18. Patients thought to be unreliable or incapable of complying with the requirements of the protocol
    19. Patient is relative of, or staff directly reporting to the investigator
    20. Patient is employee of the sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Viral load of Hepatitis C
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    repeated dose treatment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    section 8.6.4 of the study protocol
    The end of the study is defined as the last follow up visit of the last patient undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-02-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    section 8.6.2 of the study protocol
    There is no study-specific provision of further treatment and additional medical care of the patients once their participation in the trial has ended. Afterwards the patient will be treated with medication prescribed by his/her general practitioner.
    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 Decision2008-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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