Long-term Safety Study of Treatment With the Thrombopoiet... | NCT01443351

Studies
Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)

NCT01443351

Sponsor

Zealand University Hospital

Status

Withdrawn

Last Update Posted

Sep 11, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Idiopathic Thrombocytopenic Purpura

Interventions

Not provided

Countries

Denmark

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

failure to recruit patients

Expanded Access Info

Start Date

Mar 2015Actual

Primary Completion Date

Aug 2019Actual

Completion Date

Aug 2019Actual

First Submitted Date

Sep 13, 2011

First Submission Date that Met QC Criteria

Sep 28, 2011

First Posted Date

Sep 29, 2011Estimated

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

Sep 9, 2019

Last Update Posted Date

Sep 11, 2019Actual

Name	Class
Rigshospitalet, Denmark	OTHER
Odense University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for long-term effects of these drugs. In this observational study, effects and adverse effects including evaluation of bone marrow biopsies done at fixed intervals will be recorded from ITP patients treated with TPO-ra. For some patients, blood samples will be collected for research use.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Label	Type	Description	Intervention Names
ITP patients		Patients with refractory ITP eligible for treatment with TPO-ra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with sustained response at 6 months follow-up	Response is defined as platelet count > 30.000 mio/L and no bleeding	6 months

Secondary Outcomes

Measure	Description	Time Frame
Yearly response rates	Number of patients with response to treatment at 1, 2, 3, 4, and 5-year follow-up	5 years
Frequency of relapse		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with ITP
platelet counts < 25 x10*9/L or < 50 x10*9/L with bleeding symptoms
meets criteria for treatment with TPO-ra
Females must use contraceptives when applicable for at least three months before inclusion

Exclusion Criteria:

Pregnancy or nursing
Former thromboembolic events excluding one incidence of deep venous thrombosis as complication to surgery or pregnancy or one incidence of cerebral embolism as complication to atrial fibrillation
Liver insufficiency (for eltrombopag only)
TPO-ra contraindications (e.g. allergy)
TPO-ra treatments less than 6 months prior to inclusion

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

Patinets will be selected from Departments of Hematology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Hasselbalch, Prof., MD	Department of Hematology, Copenhagen University Hospital Roskilde	Principal Investigator
Henrik Frederiksen, Dr., MD	Odense University Hospital	Principal Investigator
Sif Gudbrandsdottir, MD	Copenhagen University Hospital Roskilde	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital Roskilde		Roskilde		4000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic
D055728	Primary Myelofibrosis

Ancestor Terms

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided