Using ROMIPLOSTINE for Persistent Thrombocytopenia With T... | NCT01980030

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Nov 2018Actual

First Submitted Date

Nov 4, 2013

First Submission Date that Met QC Criteria

Nov 4, 2013

First Posted Date

Nov 8, 2013Estimated

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

Feb 13, 2019

Last Update Posted Date

Feb 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is a Phase I/II multicenter study which aims to assess the toxicity profile of Romiplostim in patients with transfusion-dependent thrombocytopenia after allogeneic HSCT.

A total of 24 patients with transfusion-dependent thrombocytopenia after allogeneic HSCT will be included.

The main endpoint is the incidence and severity of adverse events.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Label	Type	Description	Intervention Names
Romiplostim	Experimental	Weekly Romiplostim for 12 weeks with intra-patient weekly dose escalation from 1µg/Kg to a maximum dose of 10 µg/Kg with a dose reduction schema in case of platelet overshoot	Drug: Romiplostim

Name	Type	Description	Arm Group Labels	Other Names
Romiplostim	Drug		Romiplostim

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	Incidence and severity of all adverse events	12 months

Secondary Outcomes

Measure	Description	Time Frame
Dose of Romiplostim	Dose of Romiplostim required to reach a platelet count above 50 x 109/L in absence of platelet transfusion	12 months
Durable platelet response after transplant:	platelet count above 50 x 109/L on 8 consecutive weeks independent of platelet transfusions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be ≥ 18 years, willing and able to sign informed consent
Patients could have been transplanted for hematological disorder (malignant or non-malignant) excepted myelodysplastic syndromes patients and had received either a myeloablative or a reduced intensity conditioning. All sources of allogeneic stem cells are allowed.
Prolonged (> 2 months) transfusion-dependent thrombocytopenia
Screenings mean platelet count≤ 20 x giga/L or screenings mean platelet count ≤ 50 x giga/L with a history of bleeding.
(ECOG) performance status of 0-2
Adequate liver function
Serum creatinine ≤ 176.8 μmol/L
Bone marrow aspirate with cytogenetics within 6 days of the first dose of romiplostim
Written informed consent

Exclusion Criteria:

Relapse/progression of hematological malignancy (marrow examination required)
Non-controlled acute and/or chronic graft versus host disease (GvHD)
Active or uncontrolled infections
Cardiac pathology - Thrombosis
Pregnancy or breast feeding
Received interleukin-11 (IL-11) within 4 weeks of screening or previously received any thrombopoietic growth factor
Patients on anticoagulant therapy
Receipt or planned receipt of Pegylated Granulocyte Colony Stimulating Factor (PEG-G-CSF), or Granulocyte macrophage-colony stimulating factor (GM-CSF) within 4 weeks of the first dose of investigational product
Subject not using adequate contraceptive precautions, in the judgment of the investigator
Sensitivity to any Escherichia coli-derived product
Inability to comply with study procedures.
Subject currently is enrolled in or has not yet completed 30 days since ending other investigational device or drug study
No medical insurance in the French Health system

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

Not provided

Sampling Method

Not provided