NCT01444417 · FLOW

Participant flow

Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients · Source last updated 2017-02-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
Participants received weekly subcutaneous placebo for 24 weeks.
id
FG000
title
Placebo
description
Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.
id
FG001
title
Romiplostim

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
type
Ineligibility Determined
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
0
type
Withdrawal by Subject
milestones
achievements
group Id
FG000
num Subjects
20
group Id
FG001
num Subjects
42
type
STARTED
achievements
group Id
FG000
num Subjects
19
group Id
FG001
num Subjects
42
type
Received Treatment
achievements
group Id
FG000
num Subjects
18
group Id
FG001
num Subjects
41
type
COMPLETED
achievements
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
1
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

Participants who met eligibility criteria were enrolled and stratified by the following 3 age categories: ≥ 1 to \< 6 years; 6 to \< 12 years; and 12 to \< 18 years.

recruitment Details

This study was conducted at 27 centers in the United States, Canada, and Australia. Participants were enrolled from 24 January 2012 to 03 September 2014.

Complete source fields