CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
Eltrombopag (ELT)drug
Likely dose
Eltrombopag (ELT) 12.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01957176
NCT01957176Phase 4Completed
CompareCT.gov

Study 200170: A Rollover Study to Provide Continued Treatment With Eltrombopag

Novartis Pharmaceuticals·interventional·Posted Oct 8, 2013·Updated Dec 30, 2022

In Brief

A Phase 4 clinical trial evaluating Eltrombopag (ELT) for Thrombocytopaenia. Completed, enrolled 22 participants across 13 sites in 12 countries.

Detailed Summary

The objective of this study was to provide continued treatment with eltrombopag for subjects who were participating in a Novartis-sponsored investigational study with eltrombopag (parent studies 114968/ASPIRE (NCT01440374), PMA112509 (NCT00903422), and TRA105325/EXTEND (NCT00351468), receiving clinical benefit without unacceptable toxicity and to collect long-term safety data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocytopaenia
CountriesBelgium, China, France, Greece, Hong Kong, Ireland, Netherlands, Peru, Poland, Romania, South Korea, Tunisia
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 8, 2013
Enrollment StartOct 15, 2013
Primary CompletionFeb 23, 2022
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 12.7 years ago

Interventions

Eltrombopag (ELT)drug

Subjects were dosed with ELT tablets or powder for oral suspension (PfOS) based on the dosage form used in the parent study. ELT tablets were white, round film coated tablets containing ELT olamine equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg and 100 mg of ELT. ELT PfOS was a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet contained ELT olamine equivalent to 20 mg of ELT per gram of powder.