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NCT01750697 · OUTCOME

Pharmacokinetics: Volume of Distribution (Vd) of Rituximab

A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis · Source last updated 2019-06-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
From Day 1 to Day 180

What was measured

Vd is defined as the theoretical central volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vd was calculated in millilitres (mL).

Analysis population: The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample.

Groups in this outcome

Rituximab (Experimental)

Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per meter squared (mg/m\^2) once a week on Days 1, 8, 15 and 22 during the Remission Induction Phase (Day 1 (baseline) to Month 6) and were followed for a minimum of 18 months (maximum 4.5yrs) during the Follow-up Phase until the Common-closeout (CCO))

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Rituximab (Experimental)25

Reported measurements

Source class 1
Values in mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Rituximab (Experimental)22200.212Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.212
        value
        2220
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Vd is defined as the theoretical central volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vd was calculated in millilitres (mL).
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per meter squared (mg/m\^2) once a week on Days 1, 8, 15 and 22 during the Remission Induction Phase (Day 1 (baseline) to Month 6) and were followed for a minimum of 18 months (maximum 4.5yrs) during the Follow-up Phase until the Common-closeout (CCO))
    id
    OG000
    title
    Rituximab (Experimental)
param Type
GEOMETRIC_MEAN
population Description
The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample.
reporting Status
POSTED
time Frame
From Day 1 to Day 180
title
Pharmacokinetics: Volume of Distribution (Vd) of Rituximab
type
PRIMARY
unit Of Measure
mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice