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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thrombotargets Europe S.L
ClinicalTrials.gov Identifier:
NCT01595360
First received: May 3, 2012
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Tooth Extraction
Drug: Placebo
Drug: TT-173
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Thrombotargets Europe S.L:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax, Tmax, AUC and bioavailability [ Time Frame: 48 h ] [ Designated as safety issue: No ]
  • Determine the presence of coagulation disorders [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Blood platelets, Prothrombin time, Fibrinogen, Thrombin time

  • Determine the immune responses to TT-173 [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Antibody concentration

  • Time to hemostasis until cessation of bleeding [ Time Frame: time 0 until cessation of bleeding ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595360

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

Additional Information:
No publications provided

Responsible Party: Thrombotargets Europe S.L
ClinicalTrials.gov Identifier: NCT01595360     History of Changes
Other Study ID Numbers: 2010-021882-57
Study First Received: May 3, 2012
Last Updated: September 13, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee

Keywords provided by Thrombotargets Europe S.L:
TT-173
Topical Hemostatics
Hemostasis

ClinicalTrials.gov processed this record on July 22, 2014