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    Summary
    EudraCT Number:2011-000947-26
    Sponsor's Protocol Code Number:CLFF571X2201
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-21
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2011-000947-26
    A.3Full title of the trial
    Multi-center, randomized, evaluator-blind,
    active-controlled, parallel-group design to determine safety, tolerability, and efficacy of multiple daily administration of LFF571 for 10 days in patients with moderate Clostridium difficile infections (Cohort 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, tolerability, and efficacy trial of multiple daily administration of LFF571 for 10 days in patients with moderate Clostridium difficile infections
    A.4.1Sponsor's protocol code numberCLFF571X2201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01232595
    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 SponsorNovartis Pharma AG
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41613241111
    B.5.5Fax number+41613248001
    B.5.6E-mailclinicaltrial.enquiries@novartis.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.3.1Product nameLFF571
    D.3.2Product code LFF571
    D.3.4Pharmaceutical form Capsule
    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.3.9.1CAS number 1160959-55-6
    D.3.9.2Current sponsor codeLFF571
    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
    Clostridium difficile infections
    E.1.1.1Medical condition in easily understood language
    Clostridium difficile are bacteria that can cause swelling and irritation of the large intestine, or colon . This inflammation, known as colitis, can cause diarrhea, fever, and abdominal cramps.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the clinical response (clinical cure) rates of patients with mild and moderate C. difficile infections to different LFF571 dose regimens and total daily doses adminisitered orally for 10 days.
    - To characterize the dose-response relationship of different dose regimens and total daily doses of LFF571.
    - To assess the safety and tolerability of different LFF571 dose regimens and total daily doses administered orally for 10 days to C. difficile infected patients.
    - To evaluate the serum concentrations of oral LFF571 following different dose regimens in C. difficile infected patients.
    - To evaluate the fecal concentrations of LFF571 following different oral LFF571 dose regimens in C. difficile infected patients.
    E.2.2Secondary objectives of the trial
    - To evaluate the time to resolution of diarrhea during the treatment period for oral LFF571 in C. difficile infected patients.
    - To evaluate the sustained response (sustained clinical cure) rate and clinical relapse rate within at 30 days following completion of different oral LFF571 dose regimens.
    - To evaluate the microbiological response to different oral LFF571 dose regimens in patients with mild and moderate C. difficile infections.
    - To evaluate the relationship of C. difficile susceptibility to LFF571 and clinical response.
    - To evaluate the relationship of C. difficile susceptibility to LFF571 and tufA or tufB genotype.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Males and females between 18 and 90 years of age
    - Females and males of childbearing potential must agree to use highly effective methods of contraception for the entire study duration, and must not attempt to become pregnant (including in vitro fertilization, sperm donation) for at least 30 days following the last study drug administration
    - Diagnosed with primary episode or first relapse of mild and moderate C. difficile infection.
    - Received ≤24 hours of approved therapy effective for C. difficile infection in the 3 days preceding enrollment.
    - Not expected to require >72 hours of concomitant systemic or orally administered antibiotics for the treatment of other infections during the treatment period.
    - Ability to take oral medications
    E.4Principal exclusion criteria
    - Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment.
    - History of hypersensitivity or intolerance to the study drug or to drugs of similar chemical classes.
    - Other suspected cause of diarrhea.
    - Severe C. difficile infection.
    - More than one prior episode of C. difficile infection within the prior 3 months.
    - Severe underlying disease such that the patient is not expected to survive at least 3 months.
    - Abdominal surgery within 30 days prior to enrollment (major or minor abdominal surgery within 14 to 30 days prior to enrollment is allowed if the investigator determines that it does not impact gastrointestinal transit time or absorption) as well as colostomy, ileostomy, or other similar surgical procedures. Any of the following if the investigator determines it could impact gastrointestinal transit time or absorption:
    • Abdominal surgery more than 30 days prior to enrollment.
    • Chronic intestinal diseases or disorders such as Crohn’s disease, ulcerative colitis, or irritable bowel syndrome.
    - Known to have HIV infection with CD4 count <200 cells/µL (testing not required) or other clinically significant immunosuppressive disease.
    - Chemotherapy or other therapy within the 30 days prior to enrollment or during the study period that is expected to result in neutropenia requiring antimicrobial therapy during the treatment period.
    - Neutropenia (absolute neutrophil count <1000 cells/µL).
    - Renal insufficiency with a calculated creatinine clearance <30 mL/min or the need for hemodialysis or peritoneal dialysis.
    - Evidence of liver disease defined as aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or total bilirubin levels more than five times the upper limit of normal.
    - History of chronic liver disease such as cirrhosis with a Child-Pugh score of B or C.
    - Thrombocytopenia (<50,000 platelets/µL).
    - Anemia (hemoglobin value <8.0 gm/dL).
    - Currently taking or planning to take Saccharomyces boulardii during the study.
    - Expected use of anti-peristaltic drugs, cholestyramine, or colestipol from Day 1 through the end-of-therapy visit on Day 12 or 13.
    - Pregnant or nursing (lactating) women.
    - Prior enrollment in this study, CLFF571X2201.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response (clinical cure)
    E.5.1.1Timepoint(s) of evaluation of this end point
    On Day 12 or 13, the end-of-therapy
    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 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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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
    Adaptive design
    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 trial4
    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 EEA13
    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
    Canada
    Germany
    Hungary
    Iceland
    Portugal
    Spain
    United Kingdom
    United States
    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 patient last visit (LPLV)
    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 months4
    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 months4
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 132
    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)
    Each patient will be required to complete the study in its entirety and thereafter no further study treatment will be made available to them. The Investigator must provide follow-up medical care for all patients who are prematurely withdrawn from the study, or must refer them for appropriate care.
    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 Decision2012-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-08-29
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