An Open-label, Intra-participant Dose Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Immune Thrombocytopenia

Conditions

Immune Thrombocytopenia (ITP)

Brief summary

Incidence, nature, and severity of TEAEs, and serious adverse events (SAEs)

Detailed description

1. Percent of participants achieving a response. − For participants with a dose-specific baseline platelet count <30,000 cells/mm3, a response is defined as a doubling of the dose-specific baseline platelet count or a platelet count of ≥50,000 cells/mm3; − For participants with a dose-specific baseline platelet count ≥30,000 cells/mm3, a response is defined as an increase in the platelet count to >20,000 cells/ mm3 from dose-specific baseline or a platelet count of ≥80,000 cells/mm3, 2. Duration of response, 3. Absolute and percent change from the dosespecific baseline in platelet count Note: Dose-specific baseline for response analysis is defined as predose platelet count on each dosing day., 4. PK parameters of NVG-2089

Related papers

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Interventions

DRUGIMMUNOGLOBULINS

DRUGNORMAL HUMAN

DRUGFOR INTRAVASCULAR ADM.

DRUGNVG-2089

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence, nature, and severity of TEAEs, and serious adverse events (SAEs)	—

Secondary

Measure	Time frame
1. Percent of participants achieving a response. − For participants with a dose-specific baseline platelet count <30,000 cells/mm3, a response is defined as a doubling of the dose-specific baseline platelet count or a platelet count of ≥50,000 cells/mm3; − For participants with a dose-specific baseline platelet count ≥30,000 cells/mm3, a response is defined as an increase in the platelet count to >20,000 cells/ mm3 from dose-specific baseline or a platelet count of ≥80,000 cells/mm3, 2. Duration of response, 3. Absolute and percent change from the dosespecific baseline in platelet count Note: Dose-specific baseline for response analysis is defined as predose platelet count on each dosing day., 4. PK parameters of NVG-2089	—

Measure

Time frame

1. Percent of participants achieving a response. − For participants with a dose-specific baseline platelet count <30,000 cells/mm3, a response is defined as a doubling of the dose-specific baseline platelet count or a platelet count of ≥50,000 cells/mm3; − For participants with a dose-specific baseline platelet count ≥30,000 cells/mm3, a response is defined as an increase in the platelet count to >20,000 cells/ mm3 from dose-specific baseline or a platelet count of ≥80,000 cells/mm3, 2. Duration of response, 3. Absolute and percent change from the dosespecific baseline in platelet count Note: Dose-specific baseline for response analysis is defined as predose platelet count on each dosing day., 4. PK parameters of NVG-2089

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Countries

Greece, Poland, Spain

Outcome results

None listed