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Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency

NCT03814798 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-04-10

No results posted yet for this study

Summary

This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16 weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in treatment-experienced subjects with PI. An additional, separate cohort of treatment-naïve, non-randomized subjects who will not be part of the crossover are included and will receive a loading dose of 5 consecutive daily doses of IGSC 20% followed by weekly infusions of IGSC 20% starting Week 1 (Day 8) through Week 32 (end of Treatment Phase).

For treatment-experienced subjects, the study consists of a Screening Visit, Baseline Visit, 16-week Treatment Period 1, 16-week Treatment Period 2, and Final Visit/Early Termination Visit. For treatment-naïve subjects, the study consists of a Screening Visit, a Baseline Visit, a 32-week Treatment Phase, and Final Visit/Early Termination Visit.

Approximately 54 treatment-experienced subjects and approximately 6 treatment-naïve subjects will be enrolled at study centers in the United States (US) and European Union (EU).

Conditions

  • Primary Immunodeficiency

Interventions

BIOLOGICAL

IGSC 20% daily push versus every 2 weeks pump

IGSC 20% syringe daily push dosing for 16 weeks followed by every 2 weeks pump dosing for 16 weeks or the reverse sequence

BIOLOGICAL

IGSC 20% daily push versus once a week pump

IGSC 20% syringe daily push dosing for 16 weeks followed by once weekly ambulatory pump administration dosing for 16 weeks or the reverse sequence

BIOLOGICAL

IGSC 20% daily push versus 2 times per week pump

IGSC 20% syringe daily push dosing for 16 weeks followed by 2 times/week ambulatory pump administration on preselected days (eg, Monday and Thursday) not less than 3 days apart for 16 weeks or the reverse sequence

BIOLOGICAL

IGSC 20% 150 mg/kg

loading dose of IGSC 20% consisting of 5 consecutive daily doses of 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of IGSC 20% 150 mg/kg starting Week 1 (Day 8) through Week 32 using an infusion SC pump

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2020-09-30
Completion
2020-09-30
FDA Drug
Yes

Countries

  • United States

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 NCT03814798 on ClinicalTrials.gov