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Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction

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ClinicalTrials.gov Identifier: NCT01595360
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Thrombotargets Europe S.L

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.

Condition or disease Intervention/treatment Phase
Tooth Extraction Drug: Placebo Drug: TT-173 Phase 1

Detailed Description:
As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety, tolerability and efficacy of TT-113 in healthy volunteers after tooth extraction.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Open, Controlled, Comparative Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction
Study Start Date : April 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
It is applied directly to the bleeding site after tooth extraction
Experimental: TT-173
TT-173
 Drug: TT-173
It is applied directly to the bleeding site after tooth extraction


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Cmax, Tmax, AUC and bioavailability [ Time Frame: 48 h ]
  2. Determine the presence of coagulation disorders [ Time Frame: 4 months ]
    Blood platelets, Prothrombin time, Fibrinogen, Thrombin time

  3. Determine the immune responses to TT-173 [ Time Frame: 4 months ]
    Antibody concentration

  4. Time to hemostasis until cessation of bleeding [ Time Frame: time 0 until cessation of bleeding ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects to be undertaken for the simple extraction of at least one tooth (incisor, canine, premolar, molar different of third molar) that cause bloody wound, located in the upper or inferior maxillary area of the mouth either
  • Subjects who are able and willing to provide written and signed informed consent
  • All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits. Negative pregnancy test result in the screening visit.

Exclusion Criteria:

  • Subjects with personal and family history that could affect correct hemostasis
  • Subjects with any clinically-significant coagulation disorder including including deficiencies in any of coagulation factors, thrombocytopenia and vascular purpura
  • Subject with hipersensivity of TT-173 of any of its components or has a known allergy.
  • Subjects who are unable to adequately follow or understand the instructions and requirements of the study.
  • Subjects that are not fully free to give informed consent, or any other obstacle in the opinion of investigator support the conclusion that the subject is not fully reasoned.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595360


Locations
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Spain
Thrombotargets Europe SL
Castelldefels, Barcelona, Spain, 08860
Sponsors and Collaborators
Thrombotargets Europe S.L
More Information
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Additional Information:

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Responsible Party: Thrombotargets Europe S.L
ClinicalTrials.gov Identifier: NCT01595360    
Other Study ID Numbers: 2010-021882-57
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013
Keywords provided by Thrombotargets Europe S.L:
TT-173
Topical Hemostatics
Hemostasis