NCT02076815 (TEAM-ET) is a Phase 3 clinical trial of Anagrelide retard in Essential Thrombocythemia, sponsored by AOP Orphan Pharmaceuticals AG.

Who is sponsoring NCT02076815?

NCT02076815 is sponsored by AOP Orphan Pharmaceuticals AG.

What drugs are being tested in NCT02076815?

Interventions in NCT02076815: Anagrelide retard, Thromboreductin.

What condition does NCT02076815 study?

NCT02076815 studies Essential Thrombocythemia.

Is NCT02076815 still recruiting?

NCT02076815 is currently completed. Last updated 27 July 2015.

Last reviewed 2015-07-27 · How we verify

NCT02076815: TEAM-ET

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase III Randomized, Multicenter, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Two Different Anagrelide Formulations in Patients With Essential Thrombocythemia (TEAM-ET 2.0)

Completed Phase 3 Last updated 27 July 2015

What this trial tests

Phase 3 trial testing Anagrelide retard in Essential Thrombocythemia in 106 participants. Completed in 1 April 2015.

Timeline

1 February 2014

Primary endpoint
1 February 2015

1 April 2015

Quick facts

Lead sponsor	AOP Orphan Pharmaceuticals AG
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	106
Start date	1 February 2014
Primary completion	1 February 2015
Estimated completion	1 April 2015
Sites	19 locations across Austria, Bulgaria, Lithuania, Poland, Russia

Drugs / interventions tested

Anagrelide retard — full drug profile →
Thromboreductin — full drug profile →

Conditions studied

Essential Thrombocythemia — all drugs for Essential Thrombocythemia →

Sponsor

AOP Orphan Pharmaceuticals AG — full company profile →

Who can join

18 and older, any sex, with Essential Thrombocythemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Platelet count
Time frame: weeks 13-17
Mean value from three measurements

Sponsor's own description

The purpose of this study is determine whether Anagrelide Retard is non-inferior to anagrelide immediate release form in treatment of essential thrombocythemia. Essential thrombocythemia (ET) is a myeloproliferative neoplasm characterised by a sustained increase in platelet counts above the normal value (\> 450 x 109/L) and increased megakaryopoiesis in the bone marrow, without secondary causes of thrombocytosis. Anagrelide hydrochloride selectively reduces platelet numbers by inhibiting megakaryocyte development and maturation in humans, without affecting other cell lineages. Anagrelide Retard is a new, prolonged release (PR) tablet formulation of anagrelide developed by AOP Orphan Pharmaceuticals AG. The rationale for developing this new formulation is based on the assumption of having a better tolerability while maintaining an efficacy comparable to that of the immediate release formulation. The effects of Anagrelide Retard and Thromboreductin® will be compared in terms of mean platelet count measured by a central laboratory/centralized method at 3 time points during the maintenance phase.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Essential Thrombocythemia

Currently open trials in the same condition.

NCT06661915 — A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs) · Phase 2 · recruiting
NCT06734637 — Efficacy and Safety of Peginterferon in ET and PV. · NA · recruiting
NCT06456346 — Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) · Phase 3 · recruiting
NCT06361641 — Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes · NA · recruiting
NCT06378437 — A Study of GLB-001 in Patients With Myeloid Malignancies · Phase 1 · recruiting

Other AOP Orphan Pharmaceuticals AG trials

Trials by the same sponsor.

NCT06514807 — A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02076815 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AOP Orphan Pharmaceuticals AG
Last refreshed: 27 July 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02076815.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing