Search for a trial

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

The primary objective of this study is to evaluate the efficacy of roxadustat compared todarbepoetin alfa in the treatment of anemia in non-dialysis dependent Chronic Kidney Disease (NDD-CKD)subjects.The secondary objectives of this study are to:*…

Randomized double blind placebo controlled PK/PD study on the effects of a single intravenous dose of NOX-H94 on serum iron during experimental human endotoxemia

Primary Objective•To assess the pharmacodynamic response after single dose administration of NOX H94 in healthy subjects during experimental endotoxemia.Secondary Objective• To determine the pharmacodynamic effects of NOX H94 after single dose…

Can the steady-state hematopoiesis be improved post-ASCT by infusion of the autologous stem cell transplant directly in the bone marrow compartment?

To improve the steady hematopoiesis post-ASCT by infusing the autologous transplant directly in the bone marrow compartment.(protocol page 6)

Iron and Folic acid v.s. Iron solely in the treatment of post partum anaemia,
effects on haemoglobin and health status

our main objective is to determine whether additional folic acid to ferrous fumarate contributes to the increase of haemoglobin and the improvement of health status in post partum anaemia. Our second objective is to asses what the difference in…

A phase II, open-label, non-controlled, intra-patient dose-escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia (CETB115E2201)

To characterize the PK of eltrombopag at steady state after oral administration in pediatric patients with SAA.Secondary (key only, see protocol page 40-41 for all objectives): Safety and tolerability. Efficacy (overall response rate ORR).

A Phase 3, Open -label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin alfa for the Treatment of Anemia due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naïve Subjects who require Red Blood Cell Transfusions.

This study has been transitioned to CTIS with ID 2022-501485-22-00 check the CTIS register for the current data. Primary objective:• To evaluate the efficacy of luspatercept on RBC transfusion independence (RBC-TI for 12 weeks [84 days] with an…

A phase 3B, open-label, single-arm, rollover study to evaluate long-term safety in subjects who have participated in other Luspatercept (ACE-536) clinical trials.

This study has been transitioned to CTIS with ID 2022-502498-40-00 check the CTIS register for the current data. Primary Objective: To evaluate the long-term safety (including progression to acute myeloid leukemia (AML) and/or other malignancies/pre…

An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis

Primary objectiveTo evaluate preliminary efficacy of itacitinib (INCB039110) on spleen volume reduction (SVR) from baseline at Week 24 in the 2 following cohorts of MF subjects:- Cohort A: in combination in subjects with ruxolitinib low dose (less…

SOAR Trial Interventional phase II single-arm study to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia.

Primary: To evaluate the efficacy of eltrombopag + cyclosporine as first-line therapy on overall hematologic response (neutrophil, platelet, hemoglobin) by 6 months.Secondary: Overall hematologic response (neutrophil, platelet, hemoglobin) by 3 and…

A Phase 3, Double-Blind, Randomized Study To Compare The Efficacy And Safety Of Luspatercept (ACE-536) Versus Placebo For The Treatment Of Anemia Due To IPSS-R Very Low, Low, Or Intermediate Risk Myelodysplastic Syndromes In Subjects With Ring Syderoblasts Who Require Red Blood Cell Transfusions

The primary objective is:* To evaluate RBC transfusion independence (RBC-TI) of luspatercept compared with placebo for the treatment of anemia due to IPSS-R very low, low, or intermediate risk MDS in subjects with ring sideroblasts (* 15%) who…

A randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)

Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…

Preterm Oxygenation of the Cerebrum: Key for Erythrocyte-transfusion Threshold, a randomized controlled trial

Our primary objective is to test our hypothesis that lower Hb thresholds than the current ones, provided adequate cerebral oxygen saturation values are met, will lead to a better neurological outcome in preterm infants at three monts post-term. Our…