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    Summary
    EudraCT Number:2015-001535-21
    Sponsor's Protocol Code Number:RG101-02
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-23
    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 ConcernedGreece - EOF
    A.2EudraCT number2015-001535-21
    A.3Full title of the trial
    A Randomized, Multi-Center, Phase 2 Study to Evaluate Safety and Efficacy of Subcutaneous Injections of RG-101 in Combination with Oral Agents in Treatment Naïve, Genotype 1 and 4, Chronic Hepatitis C Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in patients with the liver disease caused by the hepatitis C virus for assessment of safety and efficacy of RG-101 injections (test product) given in combination with other registered drugs that are to be taken by mouth
    A.4.1Sponsor's protocol code numberRG101-02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegulus Therapeutics Inc.
    B.1.3.4CountryUnited States
    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 supportRegulus Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccelsiors CRO and Consultancy Services Ltd
    B.5.2Functional name of contact pointClinical Trials Info
    B.5.3 Address:
    B.5.3.1Street Address50 Miskolci Str
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1147
    B.5.3.4CountryHungary
    B.5.4Telephone number+361299 00 91
    B.5.5Fax number+361299 00 96
    B.5.6E-mailclinicaltrials@accelsiors.com
    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.3.2Product code RG-101
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRG2459
    D.3.9.3Other descriptive nameRG2459
    D.3.9.4EV Substance CodeSUB169722
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Treatment Naïve, Genotype 1 and 4, Chronic Hepatitis C Patients
    E.1.1.1Medical condition in easily understood language
    Liver disease caused by the hepatitis C virus, Genotype 1 and 4
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10076315
    E.1.2Term Hepatitis C virus genotype 4 positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10074391
    E.1.2Term Chronic hepatitis C virus genotype 1
    E.1.2System Organ Class 100000004862
    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 efficacy of 2 mg/kg RG-101 when given in combination with oral agents for 28 days in HCV genotype 1 and 4 subjects in terms of change in viral load at Week 17 (12 weeks post treatment).
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of 2 mg/kg RG-101 when given in combination with oral agents in HCV genotypes 1 and 4 in terms of change in viral load at Week 29 (24 weeks post treatment) and Week 53 (48 weeks post treatment);
    • To assess the safety and tolerability of RG-101 when given in combination with oral agents in HCV genotypes 1 and 4;
    • To assess the time to viral load clearance in each of the genotypes and treatment arms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Both males and females of age 18 to 65 (inclusive) infected with one of the HCV genotype 1 or 4;
    2. BMI: 18.0 – 35.0 kg/m2;
    [BMI (kg/m2) = Body weight (kg) ÷ Height2 (m2)];
    3. Clinical and laboratory findings consistent with a clinical diagnosis of Chronic Hepatitis C (CHC), including:
    • Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment,
    or
    • Positive HCV serology (HCV antibody or HCV RNA) less than 24 weeks with a prior remote risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C
    and
    • Serum HCV RNA ≥ 375,000 copies/mL or ≥ 75,000 IU/mL at Screening;
    4. HCV treatment-naïve;
    5. Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met:
    • Platelets >100x109/L
    • Total white blood cells >3.0x109/L and absolute neutrophil count >1.5x109/L
    • Hemoglobin >10.95 g/dL for females and >11.92 g/dL for males
    • Total and direct bilirubin within normal limits (except for clearly documented Gilbert’s Syndrome)
    • ALAT < 5x ULN
    • Serum creatinine within normal limits or increased up to 1,5 ULN and estimated creatinine clearance rate as calculated by the Cockcroft-Gault formula > 60 mL/min
    6. All women of childbearing potential must have a negative serum pregnancy test at Screening. They should be using or willing to use a highly effective method of birth control: diaphragm, condom (by the partner), copper intrauterine device (or hormonal), sponge, or spermicide, and hormonal contraceptives. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, s.c., intrauterine, or intramuscular agents). Reliable contraception should be maintained from the Screening, throughout the whole study (W53);
    7. Male subjects must agree to use birth control (condoms) from the time of dosing until 90 days after the Treatment Period; male subjects who are surgically sterile need not employ a method of contraception;
    8. Negative results on the screening alcohol saliva test. Subjects should be able and willing to limit the alcohol intake to a maximum of 5 units per week during the whole study period (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits);
    9. Negative results on the following screening laboratory tests: urine drug screen [opiates, cocaine, heroin, amphetamines (including ecstasy), barbiturates, benzodiazepines, tricyclic antidepressants; exceptions are cannabinoids and methadone], HBsAg, and HIV antibody;
    10. Willingness to sign the ICF and obvious ability (mental and physical) to adhere to all study procedures.
    E.4Principal exclusion criteria
    1. Other known cause of liver disease except for CHC;
    2. History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding, fibrosis or other signs of hepatic insufficiency or portal hypertension;
    3. History of hepatocellular carcinoma or current liver mass consistent with malignancy on imaging studies;
    4. Serum alpha-fetoprotein (AFP) >50 ng/mL at Screening;
    5. Concurrent clinically significant medical diagnosis (other than hepatitis C-related conditions) that would potentially interfere with the subjects study compliance or confound study results including but not limited to: cardiac disease (unstable angina, myocardial infarction, congestive heart failure, or ventricular arrhythmia); cancer; uncontrolled seizure disorder; esophageal bleeding; ascites; chronic infection other than HCV (e.g., tuberculosis); uncontrolled diabetes;
    6. Fibrosis scan score > F4 at Screening or within past 6 months;
    7. Concurrent social conditions (e.g., drugs, alcohol) which would potentially interfere with the subject’s study compliance;
    8. Use of anticonvulsants, antimycobacterials, analeptics and herbal supplements that may interact with the bioavailability of the investigational product or oral DAA agents; or other alternative medicines that may have influence on the disease outcome;
    9. Mental handicap or history of or current significant psychiatric disease (which might impair ability to provide informed consent);
    10. Clinically significant illness within 30 days prior to Screening;
    11. Have used an investigational drug or has participated in an investigational study with a licensed drug within 30 days or 5 half-lives, whichever is longer, prior to study drug administration;
    12. History of relevant drug and/or food allergies;
    13. Nursing females;
    14. Any surgical procedure requiring general anesthesia planned to occur during the study period;
    15. Donation of more than 500 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 liters of blood (for men) / more than 1.0 liter of blood (for women) in the 10 months prior to Screening.
    E.5 End points
    E.5.1Primary end point(s)
    For each treatment arm within Cohorts 1 and 2 the proportion of subjects (90% Clopper-Pearson CI) attaining SVR12 will be estimated.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 17 (12 weeks post treatment, SVR12)
    E.5.2Secondary end point(s)
    Viral load related
    • Proportion of subjects with SVR at Week 29 (24 weeks post treatment, SVR24) and Week 53 (48 weeks post treatment, SVR48) in HCV genotypes 1 and 4;
    • Time to viral load clearance in each of the genotypes and treatment arms;
    • Proportion of relapsed subjects in each HCV genotype;
    • Proportion of non-responders and partial responders;
    • Proportion of subjects with viral resistance development at Week 53 (48 weeks post treatment, SVR48) or early termination;
    • Change in viral loads across visits.
    Biochemical response related
    • Changes in liver enzymes during the study course.
    Morphological responses
    • Changes from baseline in fibroscan values at the study end or early termination.
    Exploratory endpoints:
    • Changes from baseline in Patient Reported Outcomes (PRO) as measured through 3 different PRO instruments:
    o Short Form-36 version 2 (SF-36v2)
    o Chronic Liver Disease Questionnaire for Hepatitis (CLDQ-HCV)
    o The Functional Assessment of Chronic Illness (FACIT-F)
    Pharmacokinetic endpoints
    • Trough and other post-distribution phase concentrations of RG-101 related moieties [RG1649 (consisting of RG1649 and/or RG1649A), RG2459 (consisting of RG2459 and/or its GalNAc-on metabolites), and/or a combined concentration of RG1649 and RG2459].
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 29 (24 weeks post treatment, SVR24) and Week 53 (48 weeks post treatment, SVR48), during the study course and at the study end or early termination.
    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 Yes
    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 No
    E.8.1.1Randomised Yes
    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 No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Greece
    Hungary
    Lebanon
    Russian Federation
    Serbia
    E.8.7Trial has a data monitoring committee No
    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
    Last visit of the last subject
    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 months3
    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 months3
    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.1.2.1Number of subjects for this age range: 53
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 54
    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)
    After the end of the study treatment, each patient would be treated according to standard clinical practice.
    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 Decision2015-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-18
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