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

NCT03275454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-18

No results posted yet for this study

Summary

The purpose of this study is to explore the safety, preliminary clinical benefit, and activity of BIVV009 in patients with chronic immune thrombocytopenia.

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.

Sponsors & Collaborators

  • Bioverativ, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2021-02-16
Completion
2021-02-16
FDA Drug
Yes

Countries

  • United States
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275454 on ClinicalTrials.gov