Trials / Completed
CompletedNCT03275454
A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)
A Phase 1 Safety, Tolerability, and Pharmacokinetics & Pharmacodynamics Study of Multiple- Dose BIVV009 in Patients With Chronic Immune Thrombocytopenia (ITP)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Bioverativ, a Sanofi company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-08-14
- Primary completion
- 2021-02-16
- Completion
- 2021-02-16
- First posted
- 2017-09-07
- Last updated
- 2023-05-18
Locations
5 sites across 3 countries: United States, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03275454. Inclusion in this directory is not an endorsement.