Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

PHASE3CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

September 9, 2021

Primary Completion Date

August 22, 2023

Study Completion Date

October 19, 2023

Conditions
Idiopathic Thrombocytopenic Purpura
Interventions
BIOLOGICAL

GNR-069

Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg.

BIOLOGICAL

Nplate

Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg.

Trial Locations (18)

111123

"State Budgetary Institution of Healthcare of the city of Moscow Moscow Clinical Scientific and Practical Center named after A.S. Loginov Department of Health of the city of Moscow.", Moscow

125167

"Federal State Budgetary Institution National Medical Research Center for Hematology of the Ministry of Health of the Russian Federation", Moscow

125284

"State budgetary health care institution of the city of Moscow Clinical Hospital named after S.P. Botkin of the Department of Health of the city of Moscow", Moscow

127644

"State budgetary health care institution of the city of Moscow City Clinical Hospital named after V.V. Veresaev of the Department of Health of the City of Moscow", Moscow

129110

"State Budgetary Health Institution of the Moscow Region Moscow Regional Research Clinical Institute named after M.F. Vladimirsky", Moscow

197341

"Federal State Budgetary Institution National Medical Research Center named after V.A. Almazov of the Ministry of Health of the Russian Federation", Saint Petersburg

248007

"State Budgetary Health Institution of the Kaluga Region Kaluga Regional Clinical Hospital", Kaluga

300053

"State Health Institution of the Tula Region Tula Regional Clinical Hospital", Tula

344022

"Federal State Budgetary Educational Institution of Higher Education Rostov State Medical University of the Ministry of Health of the Russian Federation", Rostov-on-Don

410012

"Federal State Budgetary Educational Institution of Higher Education Saratov State Medical University named after V.I. Razumovsky of the Ministry of Health of the Russian Federation", Saratov

443099

"Federal State Budgetary Educational Institution of Higher Education Samara State Medical University of the Ministry of Health of the Russian Federation", Samara

450008

"Federal State Budgetary Educational Institution of Higher Education Bashkir State Medical University of the Ministry of Health of the Russian Federation", Ufa

603126

"State budgetary institution of health care of the Nizhny Novgorod region Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko", Nizhny Novgorod

603137

"Llc Medis", Nizhny Novgorod

620137

"Municipal budgetary institution Central City Hospital No. 7", Yekaterinburg

630091

"Federal State Budgetary Educational Institution of Higher Education Novosibirsk State Medical University of the Ministry of Health of the Russian Federation", Novosibirsk

650066

"State Autonomous Healthcare Institution Kuzbass Clinical Hospital named after S.V. Belyaev", Kemerovo

664079

"State Budgetary Institution of Healthcare Irkutsk awarded the Sign of Honor Order Regional Clinical Hospital", Irkutsk

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY

NCT05220878 - Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP | Biotech Hunter | Biotech Hunter