NCT01595360

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 16, 2013

Status Verified

September 1, 2013

Enrollment Period

1.4 years

First QC Date

May 3, 2012

Last Update Submit

September 13, 2013

Conditions

Tooth Extraction

Keywords

TT-173Topical HemostaticsHemostasis

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    4 months

Secondary Outcomes (4)

  • Cmax, Tmax, AUC and bioavailability

    48 h

  • Determine the presence of coagulation disorders

    4 months

  • Determine the immune responses to TT-173

    4 months

  • Time to hemostasis until cessation of bleeding

    time 0 until cessation of bleeding

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

TT-173

EXPERIMENTAL

TT-173

Drug: TT-173

Interventions

PlaceboDRUG

It is applied directly to the bleeding site after tooth extraction

Placebo
TT-173DRUG

It is applied directly to the bleeding site after tooth extraction

TT-173

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thrombotargets Europe SL

Castelldefels, Barcelona, 08860, Spain

Location

Related Links

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 10, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 16, 2013

Record last verified: 2013-09

Locations

ES(1)