NCT02134483

Brief Summary

Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of permanent hypoparathyroidism. However, it is a difficult process that requires a number of trained staff and advanced laboratory equipment which bring high costs. In this study, we have identified a new PA-t technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

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

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

May 1, 2014

Last Update Submit

February 20, 2017

Conditions

Parathyroid Allo-transplantation

Keywords

ParathyroidPermanent hypocalcemiaTransplantation

Outcome Measures

Primary Outcomes (1)

  • to mesure patient's blood calcium

    up to three months

Secondary Outcomes (1)

  • to mesure patient's parathormon levels

    up to three months

Other Outcomes (1)

  • to control patient's need for calcium containing drugs

    up to three months

Study Arms (1)

Parathyroid allo-transplantation

EXPERIMENTAL

patients who have permanent hypoparatyroidism

Biological: Parathyroid allo-transplantation

Interventions

Parathyroid allo-transplantationBIOLOGICAL

parathyroid allotransplantation with a new tecnique without immunosuppression

Parathyroid allo-transplantation

Eligibility Criteria

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

You may qualify if:

  • patients who have permanent hypocalcemia
  • Patients who accept to participate to study

You may not qualify if:

  • Patients who don't accept to participate to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Istanbul, 34093, Turkey (Türkiye)

Location

Study Officials

  • erhan aysan

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Bezmialem Vakif University

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 9, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

TU(1)