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    Summary
    EudraCT Number:2010-020484-20
    Sponsor's Protocol Code Number:20621-200
    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:2011-05-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-020484-20
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO ASSESS THE SAFETY AND EFFICACY OF VP 20621 FOR PREVENTION OF RECURRENCE OF CLOSTRIDIUM DIFFICILE INFECTION (CDI) IN ADULTS PREVIOUSLY TREATED FOR CDI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to determine if VP 20621 can prevent another episode of Clostridium difficile infection (CDI) in adults who were already treated for CDI
    A.4.1Sponsor's protocol code number20621-200
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01259726
    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 SponsorViroPharma Incorporated
    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 supportViroPharma Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViroPharma Incorporated
    B.5.2Functional name of contact point20621-200 Study Team
    B.5.3 Address:
    B.5.3.1Street Address730 Stockton Drive
    B.5.3.2Town/ cityExton, Pennsylvania
    B.5.3.3Post code19341
    B.5.3.4CountryUnited States
    B.5.4Telephone number1610321 6215
    B.5.5Fax number1610458 7300
    B.5.6E-mailVP20621-200@viropharma.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 nameVP 20621 Oral Liquid
    D.3.2Product code NTCD M3
    D.3.4Pharmaceutical form Oral liquid
    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.3.9.2Current sponsor codeVP 20621
    D.3.9.3Other descriptive nameNTCD M3
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeNon-toxigenic strain (M3) of Clostridium difficile
    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.3.1Product nameVP 20621 Oral Liquid
    D.3.2Product code NTCD M3
    D.3.4Pharmaceutical form Oral liquid
    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.3.9.2Current sponsor codeVP 20621
    D.3.9.3Other descriptive nameNTCD M3
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeNon-toxigenic strain (M3) of Clostridium difficile
    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 placeboOral liquid
    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
    Clostridium difficile infection
    E.1.1.1Medical condition in easily understood language
    Clostridium difficile infection: Infection of the intestines, which can be severe, by types of C difficile that make chemicals (toxins). Mostly affects people given antibiotics, bacteria killing drugs
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054236
    E.1.2Term Clostridium difficile infection
    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
    The objectives of this study are to: (1) evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4) select a dose regimen of VP 20621 to be used in future studies.
    E.2.2Secondary objectives of the trial
    None.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for this protocol, subjects must:
    1. Be ≥18 years of age.
    2. Have been diagnosed with a qualifying episode of CDI, defined as ALL of the following:
    • ≥3 unformed (loose or watery) stools within a 24-hour period.
    • A documented positive C. difficile toxin assay (enzyme immunoassay [EIA] or cellular cytotoxicity assay) or DNA PCR assay for toxigenic C. difficile from a stool sample collected while the subject was symptomatic; or documented colonic pseudomembranes on endoscopy.
    • The diarrhea must have been considered unlikely to have another etiology.
    3. Have a qualifying episode of CDI with symptoms that started within 28 days (inclusive) prior to the day of randomization.
    4. Have a qualifying episode of CDI that is either a primary episode or a first recurrence of a prior episode.
    • Primary episode: the subject had no episodes of CDI (other than the qualifying episode) within 6 months before the day of randomization.
    • First recurrence: the subject had only one episode of CDI (other than the qualifying episode) within 6 months before the day of randomization; the prior episode of CDI was diagnosed within 8 weeks before the onset of symptoms of the qualifying episode of CDI, and subsequently resolved (in the opinion of the investigator) at least 2 days before the onset of the qualifying episode of CDI.
    5. At the time of randomization, have been treated for the qualifying episode of CDI with a single course of metronidazole or oral vancomycin for a total of at least 10 and no more than 21 days. [The treatment may have switched between metronidazole (oral or intravenous) and oral vancomycin, provided that the total treatment course was of 10 21 days duration (inclusive).]
    6. Have recovered from the qualifying episode of CDI, defined as ALL of the following:
    • <3 unformed (loose or watery) stools per day for at least 2 consecutive days prior to and continuing to the time of randomization.
    • Abdominal discomfort must be absent or only mild for at least 2 consecutive days prior to and continuing to the time of randomization.
    7. Be randomized such that the first dose of study drug is administered 1 calendar day (or at most 2 calendar days) after the end of the course of metronidazole or oral vancomycin.
    8. Be willing and able to follow study procedures (e.g., study visits, provide stool samples according to the study schedule, and reliably record information in a study diary), or have a caregiver who can ensure that study procedures are followed.
    9. If female, be post-menopausal (cessation of menses greater than or equal to 1 year), surgically sterile or following an acceptable non-hormonal method of birth control such as abstinence, intrauterine device, or barrier control for at least 1 complete menstrual cycle before the screening visit, or using estrogen/progestin containing products for at least 3 months before the screening visit through discharge from the study.
    10. Have reliable access to telephone service to allow for contact with study personnel.
    11. Have reliable access to a refrigerator for storage of study drug.
    12. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed (or have a legally authorized representative provide such consent).
    E.4Principal exclusion criteria
    To be eligible for this protocol, subjects must not:
    1. Have had more than 1 episode of CDI (other than the qualifying episode) within 6 months before the day of randomization.
    2. Have received any of the following for treatment of the qualifying episode of CDI:
    • Any anti-microbial therapy other than metronidazole or oral vancomycin
    • Any immunotherapy (e.g., intravenous immunoglobulin)
    • Any toxin-binding therapy (e.g., cholestyramine [Questran], colestipol [Colestid], or colesevelam [Welchol])
    3. Have any of the following GI disorders:
    • diagnosis of inflammatory bowel disease
    • diagnosis of celiac disease
    • active irritable bowel syndrome (associated with symptoms within 6 months before the day of randomization)
    • active gastroparesis (associated with symptoms within 6 months before the day of randomization)
    • toxic megacolon during the qualifying episode of CDI
    • GI surgery within 6 weeks before the day of randomization
    4. Have received loperamide (e.g., Imodium), diphenoxylate (e.g., Lomotil), or opium tincture (including laudanum and paregoric) within 3 days before the day of randomization.
    5. Have an acute febrile illness (fever >38C [100.4F]) on Day 1 prior to the first dose of study drug.
    6. Be planning to receive any oral or parenteral (e.g., intravenous, intramuscular, or intraperitoneal) antibacterial therapy after randomization.
    7. Have any contraindication to oral/enteral therapy (e.g., severe nausea/vomiting or ileus).
    8. Have an absolute neutrophil count <1000/mm3 [1.0 x 109/L] at screening.
    9. Have a known immunodeficiency disorder, including but not limited to:
    • HIV infection
    • receiving treatment with systemic corticosteroids at a dosage equivalent to ≥10 mg/day of prednisone
    • receiving myelosuppressive cancer chemotherapy
    10. If outpatient at any time during the study, have household contacts (i.e., those who also occupy the subject’s particular housing unit as their residence during this time) who are <2 years of age or who have an immunodeficiency disorder (including but not limited to the conditions listed in Exclusion criterion #9).
    11. Require or have an anticipated need for mechanical ventilation or vasopressors for hemodynamic support during the study.
    12. Be pregnant or breastfeeding.
    13. Have participated in an active dosing phase of any other investigational (unapproved) drug evaluation within 30 days prior to the screening visit.
    14. Have any clinically significant medical or surgical condition that in the investigator’s or sponsor’s opinion could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject.
    15. Have a known hypersensitivity to any ingredient in the study formulation.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy endpoint of major interest in this study is colonization. For these analyses, colonization is defined as positive central laboratory stool C. difficile culture demonstrating VP 20621 at any time after the end of the study drug administration period. The incidence of colonization among actively treated patients will be compared with that following placebo in pairwise fashion. Secondary efficacy will include analysis of CDI recurrence within 2, 3, 4, 5, and 6 weeks of start of study drug.

    The primary analysis of safety will be the evaluation of treatment-emergent adverse events, defined as any adverse event that starts during the study drug treatment period (and up to 7 days after the last dose of the study drug), and was not seen at baseline, or was seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). This study will also include specific evaluation of adverse events of diarrhea or loose/watery stools as reported at any time throughout the study (i.e., through Week 26).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    E.5.2Secondary end point(s)
    None.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    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 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 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 No
    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.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Belgium
    Canada
    Germany
    Spain
    Switzerland
    United States
    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
    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 months7
    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 months11
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    F.4.2.2In the whole clinical trial 174
    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)
    Expected normal standard of 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 Decision2011-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
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