Clinical Trial Page

Summary
EudraCT Number:2004-002380-24
Sponsor's Protocol Code Number:TC-021-IM
National Competent Authority:Germany - PEI
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2005-12-07
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
A. Protocol Information
A.1Member State ConcernedGermany - PEI
A.2EudraCT number2004-002380-24
A.3Full title of the trial
An open randomised, prospective, multi-centre, parallel-group trial to compare efficacy and safety of TachoSil versus standard surgical treatment in patients undergoing pulmonary lobectomy for lung malingnancy and requiring treatment for air leakage.
A.3.2Name or abbreviated title of the trial where available
TachoSil versus standard surgical treatment for air leakage in pulmonary lobectomy
A.4.1Sponsor's protocol code numberTC-021-IM
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorNycomed Danmark ApS, International Medical Affairs
B.1.3.4CountryDenmark
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 organisation
B.5.2Functional name of contact point
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 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 nameTachoSil
D.3.4Pharmaceutical form
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive namehuman fibrinogen
D.3.10 Strength
D.3.10.3Concentration number5.5 mg per cm2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive namehuman thrombin
D.3.10 Strength
D.3.10.3Concentration number2.0 IU per cm2
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
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 typePlasma derived product
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
Management of pulmonary air leakage following lobectomy in subjects with lung malignancies including metastases.
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level PT
E.1.2Classification code 10024741
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To compare sealing efficacy and safety of TachoSil versus standard surgical treatment as secondary management of intra-operative pulmonary air leakage after lobectomy in subjects with lung malignancies including metastases.
E.2.2Secondary objectives of the trial
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
Pre-operative:
Informed consent obtained, 18 years of age or above, planned elective lobectomy for lung malingnancy with intrapulmonary lymphadenectomy (with antero- or postero-lateral incision), use of adequate contraception for females.

After pulmonary lobectomy:
Air leakage of grade 1 or 2
E.4Principal exclusion criteria
Pre-operative:
Previous lung surgery on the same side; anti-tumour chemotherapy within last 3 weeks; radiotherapy for lung malingnancy within last 4 weeks; allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin; emergency surgery, FEV1 (forced expiratory volume) < 40%; previousely exposure to TachoComb, TachoComb H or TachoSil; present abuse of drug or alcohol, participation in any other trial with an investigational drug or device within 30 days prior to inclusion, participation or planned praticipation in another trial during the trial period; positive pregnancy test (females) and breastfeeding (females).

After pulmonary lobectomy:
Serious complications including need for surgical adhesiolysis of the remaining lung tissue, pneumonectomy, wedge or sleeve resection of the lung, use of any fibrin sealant (including TachoSil) before randomisation.
E.5 End points
E.5.1Primary end point(s)
Duration of post-operative air leakage.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Information not present in EudraCT
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
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) No
E.7.3Therapeutic confirmatory (Phase III) Yes
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 Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
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 No
E.8.2.3Other Yes
E.8.2.3.1Comparator description
Standard surgical treatment
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.8.5The trial involves multiple Member States Yes
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 Information not present in EudraCT
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 Information not present in EudraCT
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
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months16
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial months16
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
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 Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-07. Yes
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
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.3.3.6.1Details of subjects incapable of giving consent
The subject should use adequate contraception.
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state120
F.4.2 For a multinational trial
F.4.2.1In the EEA 275
F.4.2.2In the whole clinical trial 300
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 Decision2006-01-09
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-02-27
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2007-03-19

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe