Colchicine Levels in the Serum of FMF (Familial Mediterra... | NCT03210610

Studies
Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients

NCT03210610

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Apr 20, 2018Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

FMF
Colchicine Resistance
Colchicine Toxicity

Interventions

colchicine level measurement

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 19, 2017Actual

Primary Completion Date

Jul 15, 2020Estimated

Completion Date

Jul 15, 2020Estimated

First Submitted Date

Jun 29, 2017

First Submission Date that Met QC Criteria

Jul 4, 2017

First Posted Date

Jul 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2018

Last Update Posted Date

Apr 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Merav Lidar, Director, Head of rheumatology clinic, Principal Investigator, Clinical Professor, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

in this study the investigators will measure the colchicine trough levels in 80 FMF patients taking stable doses of colchicine

Detailed Description

80 FMF patients will enroll: 20 taking 1 mg colchicine a day 20 taking 1.5 mg colchicine a day 20 taking 2 mg colchicine a day 20 taking 2.5 mg colchicine a day one blood sample for trough colchicine levels will be taken. response to treatment, colchicine side effects and anthropometric data will be collected.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FMF patients		fmf patients under a constant colchicine dose	Diagnostic Test: colchicine level measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
colchicine level measurement	Diagnostic Test	levels of colchicine will be measured in FMF patients taking colchicine	FMF patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
colchicine levels	the trough level of colchicine in the serum	a single measurement under a constant dosage at visit 1 (time=0, recruitment)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

constant colchicine levels

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

FMF patients treated with a constant dose of colchicine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
merav lidar, prof	Contact	+972-3-5304413		merav.lidar@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
merav lidar, prof	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center	Recruiting	Ramat Gan			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided