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    Summary
    EudraCT Number:2016-003749-27
    Sponsor's Protocol Code Number:FORMA-05
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-29
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-003749-27
    A.3Full title of the trial
    Prospective, Randomised, Controlled Phase 2 Study Investigating the Haemostatic Efficacy and Safety of Fibrinogen Concentrate (Octafibrin) and Cryoprecipitate as Fibrinogen Supplementation Sources in Patients Undergoing Cytoreductive Surgery for Pseudomyxoma Peritonei.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fibrinogen (blood protein) supplementation in patients that have developed fibrinogen deficiency during surgery.
    A.3.2Name or abbreviated title of the trial where available
    Phase 2 study investigating Fibrinogen Supplementation Sources
    A.4.1Sponsor's protocol code numberFORMA-05
    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 SponsorOctapharma 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOctapharma AG
    B.5.2Functional name of contact pointIrina Kruzhkova
    B.5.3 Address:
    B.5.3.1Street AddressSeidenstrasse 2
    B.5.3.2Town/ cityCH-8853 Lachen
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 (0)55 451 21 73
    B.5.5Fax number+41 (0)55 451 21 51
    B.5.6E-mailirina.kruzhkova@octapharma.ch
    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 nameOctafibrin
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFibrinogen
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number20
    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 Yes
    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 RoleComparator
    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 Information not present in EudraCT
    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 nameCryoprecipitate
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFibrinogen
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number400-460
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The sequence of events culminating in Pseudomyxoma peritonei (PMP) is thought to involve growth of an appendiceal adenoma with distension of the appendix by mucus and mucinous tumour cells. The appendix eventually ruptures. Patients undergoing the PMP surgery develop a coagulopathy predominantly characterised by reduced levels of fibrinogen, resulting in reduced whole blood clot firmness.
    E.1.1.1Medical condition in easily understood language
    Surgery performed on a cancer (tumour) in the appendix, causes decreased levels of blood clotting factor (fibrinogen).
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037138
    E.1.2Term Pseudomyxoma peritonei
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the overall (i.e. intra- and postoperative) haemostatic efficacy (ability to stop bleeding) of Octafibrin, a human blood-derived protein with that of cryoprecipitate in bleeding patients developing acquired fibrinogen deficiency during removal of tumour growth from the abdomen (cytoreductive surgery) for Pseudomyxoma Peritonei (PMP).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    To compare the intraoperative haemaostatic efficacy (ability to stop bleeding) of Octafibrin with that of cryoprecipitate in bleeding patients developing acquired fibrinogen deficiency during removal of tumour growth from the abdomen (cytoreductive surgery) for Pseudomyxoma Peritonei (PMP).

    To compare the postoperative haemostatic efficacy by study group

    To compare the capability of Octafibrin with that of cryoprecipitate to correct the acquired fibrinogen deficiency in the study population as demonstrated by an increase in Clauss plasma fibrinogen concentration.

    To analyse dose and duration of fibrinogen supplementation by study group.

    To assess the coagulation (change of blood to semi solid state) profiles by study group.

    To analyse critical care outcome data by study group.

    To determine the time to availability of Octafibrin and cryoprecipitate in the operating room.

    To investigate the safety profile of Octafibrin or cryoprecipitate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Because the need for fibrinogen supplementation will not become apparent until 60–90 minutes into the surgery, the criteria for inclusion will be assessed at two separate time points, i.e., during screening and intraoperatively.

    Note: The maximum time allowed between the Screening Assessment and surgery is 1 week.

    Inclusion criteria checked during the Screening Assessment:
    1. Patients undergoing Sugarbaker procedure for PMP
    2. Age ≥18 years
    3. Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted
    4. Patient is capable to understand and comply with the relevant aspects of the study protocol.

    Inclusion criteria checked during the Intraoperative Assessments:

    5. Intraoperative need for fibrinogen supplementation as assessed on the basis of ‘bleeding risk assessment’ (i.e., predicted average intraoperative blood loss ≥2L)

    Patients not fulfilling inclusion criteria 5 will not be randomised and will be considered screening failures.
    E.4Principal exclusion criteria
    All exclusion criteria will be assessed during screening. Patients who meet any of the following criteria are not eligible for the study:
    7. Recent history of thromboembolic disease (myocardial infarction, stroke, deep vein thrombosis, or pulmonary embolism within 2 months prior to screening)
    8. Known presence of chronic infections, such as infection with HIV or hepatitis C virus, as per medical history
    9. Undergoing emergency surgery
    10. Surgery for other forms of peritoneal malignancy or infection
    11. Receipt of fibrinogen-containing products within 14 days prior to screening.
    12. Patients with any known Ccongenital or acquired coagulation disorder (e.g., von Willebrand disease, haemophilia, or severe liver disease) or a prothrombotic disorder (e.g., protein C or S deficiency)
    13. Administration of a IIbIIIa antagonist within 1 day, clopidogrel within 5 days, ticagrelor within 2 days, and prasugrel within 7 days of screening
    14. Direct thrombin inhibitors within 3 days and factor Xa inhibitors within 2 days of screening
    15. Participation in another study within 30 days prior to screening
    16. Known hypersensitivity to the study medication
    17. Pregnant (based on urine pregnancy test) or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to compare the overall (i.e. intra and postoperative) haemostatic efficacy of Octafibrin with that of cryoprecipitate in bleeding patients developing acquired fibrinogen deficiency during cytoreductive surgery for pseudomyxoma peritonei.

    The primary efficacy endpoint is the overall haemostatic efficacy rating as assessed by the Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC). Haemostatic efficacy will be rated as 'excellent', 'good', 'moderate' or 'none' (4 point scale).

    Ratings of 'excellent' and 'good' will be considered haemostatic success', whereas ratings of 'moderate' and 'none' will be considered hamostatic failure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Intraoperative haemostatic efficacy of Octafibrin or cryoprecipitate is assessed at the end of surgery using the objective 4-point haemostatic efficacy scale discussed above.

    Postoperative haemostatic efficacy of Octafibrin or cryoprecipiatate is assessed 24 hours ± 30 minutes after the end of surgery by the haematologist using an objective 4-point scale.
    E.5.2Secondary end point(s)
    Intra operative haemostatic efficacy of Octofibrin and cryoprecipitate in controlling intraoperative bleeding as assessed at the end of surgery by the surgeon and anaesthesiologist using an objective 4-point haemostatic efficacy scale (see response above).

    Postoperative haemostatic efficacy of Octafibrin and cryoprecipitate in controlling postoperative bleeding as assessed 24 hours after the end of surgery by the haematologist using an objective 4-point scale.

    Capability of Octafibrin and cryoprecipitate to correct the acquired fibrinogen deficiency as demonstrated by an increase in Clauss plasma fibrinogen concentrations after the first post-randomisation infusion (i.e. preemptive dose).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Intraoperative haemostatic efficacy is assessed at the end of surgery by both the surgeon and the anaesthesiologist. Postoperative haemostatic efficacy is assessed 24 hours after the end of surgery by the haematologist.
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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
    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
    The study will be considered completed when 20 evaluable patients per group have completed the planned observation period, i.e., the time between the Screening Visit and the End-of-Study Visit.
    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 months6
    E.8.9.1In the Member State concerned days5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state55
    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)
    None required
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation EJ & Sons Ltd
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-20
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