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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41198   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2016-003525-42
    Sponsor's Protocol Code Number:ACH471-201
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-003525-42
    A.3Full title of the trial
    A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
    A.4.1Sponsor's protocol code numberACH471-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03124368
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1203-9016
    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 SponsorAchillion Pharmaceuticals, 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 supportAchillion Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTI Clinical Trial and Consulting Services Europe GmbH
    B.5.2Functional name of contact pointProject Manager Europe
    B.5.3 Address:
    B.5.3.1Street AddressSchillerstrasse 1/15
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89077
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 4532 2689602
    B.5.5Fax number+49 731 4000 84 29
    B.5.6E-mailrreyes@ctifacts.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 ACH-0144471
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNNot available
    D.3.9.1CAS number 1903768-17-1
    D.3.9.2Current sponsor codeACH-0144471
    D.3.9.3Other descriptive nameACH-0144471
    D.3.9.4EV Substance CodeSUB189885
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 ACH-0144471
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNNot available
    D.3.9.1CAS number 1903768-17-1
    D.3.9.2Current sponsor codeACH-0144471
    D.3.9.3Other descriptive nameACH-0144471
    D.3.9.4EV Substance CodeSUB189885
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 3
    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 ACH-0144471
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNNot available
    D.3.9.1CAS number 1903768-17-1
    D.3.9.2Current sponsor codeACH-0144471
    D.3.9.3Other descriptive nameACH-0144471
    D.3.9.4EV Substance CodeSUB189885
    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) 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
    biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level
    E.1.1.1Medical condition in easily understood language
    low C3 blood levels due to either C3G or IC-MPGN
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10077827
    E.1.2Term C3 glomerulopathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the administration of ACH-0144471 can increase C3 levels in patients with low C3 levels due to either C3G or IC-MPGN
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of ACH-0144471 in patients with C3G or IC-MPGN
    • To evaluate the pharmacokinetic (PK) profile of ACH-0144471 in patients with C3G or IC-MPGN
    • To evaluate the effect of ACH-0144471 on biomarkers of alternative pathway activity (AP) in patients with C3G or IC-MPGN
    • To explore the relationship between study drug exposure and changes in C3 levels and other biomarkers of alternative pathway activity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must be between the ages of 16 and 65 years, inclusive
    2. Must have a clinical diagnosis of C3G (C3 glomerulonephritis [C3GN] or dense deposit disease [DDD], the 2 types of C3G) or idiopathic immune-complex membranoproliferative glomerulonephritis (IC-MPGN) by renal biopsy for at least 3 months prior to dosing, with the pathologic diagnosis verified by review of the renal biopsy by the study central pathologist
    3. C3 must be <50% of the lower limit of normal (LLN)
    4. C4 must be >90% of the LLN
    5. Female patients of childbearing potential must either agree to abstinence or to use two effective methods of contraception as defined in Section 5.5.5 from screening through 3 months after the last dose of ACH-0144471. Females who are of non-childbearing potential as defined in Section 5.5.5 need not employ a method of contraception.
    6. Male patients must either agree to abstinence or to use two effective methods of contraception as defined in Section 5.5.5 throughout the dosing period and for at least 3 months after the last dose of ACH-0144471. Males who are surgically sterile need not employ additional contraception. Males must agree to not donate sperm throughout the dosing period and for at least 3 months following the last dose of ACH-0144471.
    7. Must be capable of providing written informed consent, must be willing and able to comply with the requirements and restrictions listed in the consent form and with the visit schedule, treatment plan, laboratory tests, pharmacokinetic sampling schedule, and other study procedures, and must be willing and able to return for all study visits
    8. Must be up-to-date on routine vaccinations, or be willing to be brought up-to-date, based on local guidelines
    9. Must be willing to comply with study-specific vaccination requirements for Haemophilus influenzae, Streptococcus pneumoniae, and Neisseria meningitidis strains A, C, W, and Y
    10. Must be willing, at all times for the duration of study participation, to have transportation and telephone access, and to be within one hour of an emergency medical center
    E.4Principal exclusion criteria
    1. History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. Individuals receiving renal replacement therapy are also excluded
    2. History or presence of any clinically relevant co-morbidities that would make the patient inappropriate for the study (for example, is likely to result in deterioration of the patient’s condition, affect the patient’s safety during the study, or confound the results of the study), in the opinion of the Principal Investigator
    3. Evidence of monoclonal gammopathy of unclear significance (MGUS), infections,malignancy, autoimmune diseases, or other conditions to which C3 glomerulopathy or IC-MPGN may be secondary
    4. Patients with other renal diseases that would interfere with interpretation of the study
    5. Presence or evidence of hepatobiliary cholestasis
    6. Known Gilbert’s syndrome and/or patients with a history suggestive of Gilbert’s syndrome
    7. Females who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration, or patients with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration
    8. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 at the time of screening or at any time over the preceding four-weeks
    9. History of febrile illness, a body temperature >38°C, or other evidence of a clinically significant active infection, within 14 days prior to study drug administration
    10. Patients with evidence of human immunodeficiency virus, hepatitis B or hepatitis C infection (positive serology for HIV-1 antibody, positive hepatitis B surface antigen, or positive anti-HCV antibody at Screening or historically)
    11. History of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection
    12. Contraindication to one or more of the required vaccinations
    13. History of hypersensitivity reactions to commonly used antibacterial agents, including beta-lactams, penicillin, aminopenicillins, fluoroquinolones, cephalosporins, and carbapenems, which, in the opinion of the investigator and/or an appropriately qualified immunology or infectious disease expert, would make it difficult to properly provide either empiric antibiotic therapy or treat an active infection
    14. Participation in a clinical study in which an investigational drug was given within 30 days, or within 5 half-lives of the investigational drug, whichever is longer, prior to study drug administration
    15. Receipt of eculizumab at any dose or interval within the past 75 days prior to dosing
    16. Use of tacrolimus or cyclosporine within 2 weeks of the first dose of ACH-0144471
    17. 12-lead electrocardiogram with a QTcF >500 msec or findings which, in the opinion of the PI, could put the patient at undue risk
    18. Any of the following laboratory abnormalities at screening:
    • Alanine transaminase > ULN
    • Aspartate aminotransferase > ULN
    • Alkaline phosphatase > ULN
    • Absolute neutrophil counts <1,000/μL
    • Total bilirubin >1.5× ULN
    • Indirect bilirubin > ULN
    • Any laboratory abnormality that, in the opinion of the PI, would make the patient inappropriate for the study, or put the patient at undue risk
    19. Donation of blood or blood products in excess of 500 mL within a 60 day period prior to the first dose of the current study
    20. Receipt of blood or blood products within 30 days of screening
    21. Clinically significant history of drug allergy as determined by the Investigator
    22. Unwilling or unable to comply with the study protocol for any reason
    E.5 End points
    E.5.1Primary end point(s)
    Increase in C3 levels relative to baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    E.5.2Secondary end point(s)
    2. Serious Adverse Events (SAEs), Grade 3 or higher Adverse Events (AEs), and AEs leading to discontinuation [Day 49]
    3. Time (in days) to achieving peak C3 levels from the first day of dosing
    4. Profile of Pharmacokinetics: Area under the curve (AUC)
    5. Profile of Pharmacokinetics: Maximum plasma concentration (Cmax)
    6. Profile of Pharmacokinetics: Time to maximum concentration (Tmax)
    7. Change in biomarkers of alternative pathway activity (AP) relative to baseline (AP Wieslab, factor D, and Bb)
    8. Relationship between ACH-0144471 exposure and changes in C3 levels and other biomarkers of alternative pathway activity (AP Wieslab, factor D, and Bb)
    E.5.2.1Timepoint(s) of evaluation of this end point
    2. Serious Adverse Events (SAEs), Grade 3 or higher Adverse Events (AEs), and AEs leading to discontinuation [Day 49]
    3. Time (in days) to achieving peak C3 levels from the first day of dosing [Day 14]
    4. Profile of Pharmacokinetics: Area under the curve (AUC) [Days 1 & 7]
    5. Profile of Pharmacokinetics: Maximum plasma concentration (Cmax) [Days 1 & 7]
    6. Profile of Pharmacokinetics: Time to maximum concentration (Tmax) [Days 1 & 7]
    7. Change in biomarkers of alternative pathway activity (AP) relative to baseline (AP Wieslab, factor D, and Bb) [Day 14]
    8. Relationship between ACH-0144471 exposure and changes in C3 levels and other biomarkers of alternative pathway activity (AP Wieslab, factor D, and Bb) [Day 14]
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Assessment of Biomarkers
    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 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 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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Australia
    Belgium
    Netherlands
    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
    LVLS Day 49 - + long term follow up
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    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)
    After the patient has finished the trial, they will have the option to participate in a 1 year therapeutic trial.
    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 Decision2018-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-09
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