NCT03275454View on ClinicalTrials.gov

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

August 14, 2017

Primary Completion Date

February 16, 2021

Study Completion Date

February 16, 2021

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

DRUG

BIVV009 6.5 grams

Participants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009.

DRUG

BIVV009 7.5 grams

Participants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009.

Trial Locations (5)

15232

University of Pittsburgh Medical Center (UPMC) Hilman Cancer Center, Pittsburgh

20057

Georgetown Lombardi Comprehensive Cancer Center, Georgetown

45147

Essen University Hospital Department of Hematology, Essen

02144

Massachusetts General Hospital - Cancer Center, Boston

WC1E 6HX

University College Hospital, London

All Listed Sponsors

lead

Bioverativ, a Sanofi company

INDUSTRY

NCT03275454 - A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP) | Biotech Hunter | Biotech Hunter