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    Summary
    EudraCT Number:2010-018361-33
    Sponsor's Protocol Code Number:HCV689-201
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-17
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2010-018361-33
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AZD7295 in Combination with Pegylated Interferon alpha-2a and Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1b Infection with Compensated Liver Disease
    A.4.1Sponsor's protocol code numberHCV689-201
    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 SponsorArrow Therapeutics Ltd. (a member of the AstraZeneca group of companies)
    B.1.3.4CountrySweden
    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 nameAZD7295
    D.3.2Product code AZD7295
    D.3.4Pharmaceutical form Capsule*
    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.3.9.1CAS number 929890-64-2
    D.3.9.2Current sponsor codeAZD7295
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number65
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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
    Chronic hepatitis C virus (genotype 1b) infection
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10019751
    E.1.2Term Hepatitis C virus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10047457
    E.1.2Term Viral 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 Rapid Virologic Response (RVR) of multiple oral doses of AZD7295 in conjunction with standard of care (SoC) in patients with chronic hepatitis C virus genotype 1b infection.
    E.2.2Secondary objectives of the trial
    1. To determine the viral load reduction of multiple oral doses of AZD7295 in conjunction with SoC in patients with chronic hepatitis C virus genotype 1b infection.

    2. To determine the safety and tolerability of multiple oral doses of AZD7295 in conjunction with SoC in patients with chronic hepatitis C virus genotype 1b infection.

    3. To determine the pharmacokinetics of multiple oral doses of AZD7295, PEG and RBV in patients with chronic hepatitis C virus genotype 1b infection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient has confirmed chronic HCV (genotype 1b) infection (diagnosis at least six months before screening), with no signs of decompensated liver cirrhosis (Child-Pugh A is acceptable).
    2. The patient’s plasma HCV RNA load is above 100,000 IU/mL.
    3. The patient (male or female) is aged 18–65 years (inclusive).
    4. The patient's BMI is in the range 18–34 kg/m2 (inclusive).
    5. The patient shows no clinically significant abnormalities in ECG.
    6. The patient is HCV treatment-naïve (this includes investigational HCV treatments).
    7. The patient is HIV- and HBV-negative.
    8. Female patients of child-bearing potential must agree to use at least 2 methods of contraception if they are not abstinent, one being a condom, for the duration of the study and for four months following the last RBV dose. In addition, during treatment with AZD7295, if females are using the oral contraceptive pill they must have been taking the same oral contraceptive for 3 months before screening and throughout the study.
    9. Male patients must agree that they and their female partners (if of child bearing potential) will use at least 2 methods of contraception (one being a condom) for the duration of the study and for 7 months following the last RBV dose (unless the patient is abstinent).
    10. The patients thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels show adequately controlled thyroid function.
    E.4Principal exclusion criteria
    1. The patient has received any investigational drug within the three months (90 days) preceding Day 1 of the study.
    2. The patient has decompensated liver disease or portal hypertension (patients with Child-Pugh A cirrhosis are acceptable).
    3. The patient shows any evidence of hepatocellular carcinoma or has a serum alpha-fetoprotein level of >500 ng/mL.
    4. The patient has had any surgery of the gastro-intestinal tract that is likely to affect drug absorption. [Note: Patients with cholecystectomy are acceptable and are not excluded by this criterion.]
    5. In the opinion of the patient’s general practitioner or hepatologist or the Investigator, the patient should not participate in the study.
    6. The patient has a history of chronic retinopathy or shows other evidence of chronic retinopathy on physical examination (history or fundoscopic evidence of retinal haemorrhage, retinal artery obstruction or retinal vein obstruction).
    7. The patient has diabetes mellitus (type I or II). [Note: Patients on stable oral medication with adequately controlled blood sugar levels are acceptable and are not excluded by this criterion.]
    8. The patient shows any evidence of chronic cardiac or pulmonary disease associated with ongoing functional limitation (e.g. NYHA grade > 1).
    9. The patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids (e.g. severe asthma, severe arthritis or autoimmune conditions, organ transplantation, adrenal insufficiency, etc.).
    10. The patient has one or more additional known primary or secondary causes of liver disease other than hepatitis C (e.g. alcoholism, malignancy with hepatic involvement, haemochromatosis, alpha 1 antitrypsin deficiency, Wilson’s disease, other congenital or metabolic conditions affecting the liver, severe cardiopulmonary disease, etc.). [Note: Gilbert’s syndrome and Dubin-Johnson syndrome (two benign disorders associated with low grade hyperbilirubinaemia, to be confirmed by laboratory tests) and Child–Pugh A cirrhosis will not exclude patients from participation in this trial.]
    11. The patient has any other concurrent medical condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study (e.g. concurrent malignancies, alcoholism, history of unstable angina, repeated myocardial infarction or congestive heart failure, haemoglobinopathies, active rheumatoid arthritis requiring chronic drug treatment, renal insufficiency, or other significant hormonal conditions, active tuberculosis under current treatment, etc.). [Note: Controlled haemophilia or hypertension are acceptable.]
    12. The patient has a history of severe psychiatric illness, including severe depression, history of suicide attempt or suicidal ideation, or psychosis requiring medication or psychotherapy. [Note: Patients with anxiety on stable medications are acceptable.]
    13. The patient has a history of a severe seizure disorder or current anticonvulsant use for control of seizures.
    14. The patient has any concurrent medical condition or laboratory abnormality that would constitute a contraindication for the use of pegylated interferon.
    15. The patient has any concurrent medical condition or laboratory abnormality that would constitute a contraindication for the use of ribavirin.
    16.The patient is currently using, and is unable to discontinue the use of any herbal medication or pharmaceutical agent that is known to be associated with hepatotoxicity
    17. The patient (if female) is pregnant or breast-feeding or (if male) has a female partner who is pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the Rapid Virologic Response (RVR) of multiple oral doses of AZD7295 in conjunction with standard of care (SoC) in patients with chronic hepatitis C virus genotype 1b infection.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    dose-finding
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    A Dose Review Group will meet at specified times throughout the trial (see protocol), to review available data from each treatment group, in order to determine the dose of study drug to be administered to subsequent treatment groups in the trial. Four treatment groups have been planned for this trial, where Groups 3 and 4 are optional. Hence, the end of the trial may occur after the completion of the Group 2 (36 patients treated) or Group 3 (50 patients) or Group 4 (64 patients).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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) Yes
    F.1.3Elderly (>=65 years) No
    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 No
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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)
    At the end of the study, all patients will continue to receive treatment with standard of care for HCV genotype 1 (pegylated interferon alpha-2a 180 mcg s.c. once weekly and ribavirin 1000 mg or 1200 mg by mouth daily). Patients will receive standard of care for 24 or 48 weeks, as determined by their viral load levels at baseline, 4 and 12 weeks, at the discretion of the physician.
    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 Decision2010-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
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