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    Summary
    EudraCT Number:2008-006833-29
    Sponsor's Protocol Code Number:BPS-MR-PAH-202Amdt4US&Belgium
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-16
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-006833-29
    A.3Full title of the trial
    An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
    A.4.1Sponsor's protocol code numberBPS-MR-PAH-202Amdt4US&Belgium
    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 SponsorLung LLC
    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 supportLung LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRLM Consulting
    B.5.2Functional name of contact pointRené Mignolet
    B.5.3 Address:
    B.5.3.1Street AddressChemin du Cyclotron; 6
    B.5.3.2Town/ cityLouvain-La-Neuve
    B.5.3.3Post code1348
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 10 39 00 84
    B.5.5Fax number+32 10 39 00 01
    B.5.6E-mailr.mignolet@rlmconsulting.be
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/554
    D.3 Description of the IMP
    D.3.1Product nameBeraprost Sodium Modified Release
    D.3.2Product code BPS-MR
    D.3.4Pharmaceutical form Modified-release 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 INNBeraprost Sodium
    D.3.9.1CAS number 88475-69-8
    D.3.9.2Current sponsor codeBPS-MR
    D.3.9.3Other descriptive nameTRK-100STP
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Pulmonary Arterial Hypertension
    E.1.1.1Medical condition in easily understood language
    Pulmonary Arterial Hypertension
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the safety of long term treatment with BPS-MR tablets in eligible patients who participate in the BPS-MR-PAH-201 study.
    E.2.2Secondary objectives of the trial
    The secondary objective s are to describe the efficacy of BPS-MR tablets on an unencouraged 6 minute walk test (6MWT), the Borg Dyspnea Scale and clinical worsening in eligible patients who participate in the BPS-MR-PAH-201 study.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Currently enrolled patients may be invited to participate in an optional four times daily (QID) dosing substudy of BPS-MR.

    In Lung LLC’s clinical development program, BPS has been administered to approximately 100 healthy volunteers and to over 50 patients with PAH. Total daily doses of BPS have ranged from 120 to 2280 µg with clinical observations of more than 2 years of exposure in many patients. In earlier multiple-dose studies with BPS-MR, steady state pharmacokinetics (PK) were achieved utilizing Q12 hour administration. Plasma concentrations of BPS, and its pharmacologically active BPS-314d isomer, were demonstrable throughout the dosing interval. However, with twice daily (BID) administration there was considerable variation between peak and trough concentrations. It has now been proposed that more constant plasma concentrations (i.e. less peak to trough variability) might maximize the therapeutic benefit and improve tolerability with oral prostanoids (i.e. similar to continuous parenteral infusion). Therefore, perhaps additional clinical benefit may be observed with more frequent dosing with BPS-MR.
    PK modeling of BPS-MR was recently performed to simulate the PK profile of BID dosing and four times daily (QID) dosing using data from a previously completed single dose study. The PK computer simulations indicated that peak-to-trough plasma concentration fluctuations would be reduced with QID dosing and more constant plasma concentrations would be maintained over the day as compared to BID dosing. Thus, it is expected, based on PK models, that QID dosing would result in more stable and consistent plasma concentrations and this may improve the therapeutic exposure of BPS over the course of daily dosing. It is also hypothesized that the tolerability profile of oral beraprost may be improved by minimizing the peak-to-trough fluctuations in plasma concentrations.
    Based on this rationale, patients in the ongoing study with BID dosing of BPS-MR are being given the opportunity to switch to QID dosing as part of a substudy with the objective to evaluate the safety, tolerability and PK of QID dosing. Patients consenting to participate will be switched from their current BID total daily dose to the same or slightly lower total daily dose for QID dosing. BPS-MR dose adjustments can then be made based on tolerability and clinical response, as noted in the main study.
    E.3Principal inclusion criteria
    Patients who remained on study drug and completed all assessements during the treatment phase of study BPS-MR-PAH-201 are eligible for this study.

    Female Patients must either be physiologically incapable of childbearing or be practicing acceptable method of birth control (e.g approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spemicide, or an intrauterine device
    E.4Principal exclusion criteria
    Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) for any reason (e.g. treatment related adverse event) are not eligible for entry into this study

    Patients who are pregnant or lactating are excluded from participation in the open-label extension
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in the BPS-MR-PAH-201 study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoint will be assessed at all study visits: Baseline, 3,6 and 12 months and annual visits and during Month 9 and quarterly phone calls.
    E.5.2Secondary end point(s)
    The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test (6MWT), the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS-MR-PAH-201 study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoint will be assessed at all study visits: Baseline, 3,6 and 12 months and annual visits
    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 No
    E.6.7Pharmacodynamic No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    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
    As per protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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) Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 19
    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 completion of trial patients will resume their intial treatment of care following physician advice
    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 Decision2008-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-26
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