TerminatedPhase 3

Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants

Stopped: Study was terminated due to low enrollment

United States1 participantsStarted 2017-08-02

Plain-language summary

A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of differentiation 34+ (CD34+) cells in at least 60 healthy male and female participants. The pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of tbo-filgrastim will be assessed.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Any IMP within 30 days or 5 half-lives (whichever is longer) before the first dose of tbo-filgrastim, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the first dose of tbo-filgrastim
✕. Known history of treatment with blood-cell colony-stimulating factors
✕. Current or recent (within 4 weeks) treatment with lithium
✕. Hemoglobin less than or equal to (\<=) 12.5 grams per deciliter (g/dL) (women) and hemoglobin \<=13.5 g/dL (men)
✕. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values of greater than (\>) 3 \* the upper limit of the normal range (ULN)
✕. Total bilirubin of \>2 \* ULN
✕. Findings of cholestasis (eg, abnormal values of alkaline phosphatase)

What they're measuring

Percentage of Participants With at Least 2*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg) of Recipient Body Weight Collected in the First Apheresis on Day 5

Timeframe: Day 5

Trial details

NCT IDNCT03029000

SponsorTeva Branded Pharmaceutical Products R&D, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10-30

Results submitted2018-11-14

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