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Gammagard Liquid and rHuPH20 in PID

NCT00814320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2021-05-19

Study results available
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Summary

The purpose of the study is to develop a subcutaneous treatment option for participants with Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency as IV administration.

Conditions

  • Primary Immunodeficiency Diseases (PID)

Interventions

BIOLOGICAL

Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)

Comprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (subcutaneous \[SC\] infusions) as bioavailability/exposure for intravenous (IV) treatment was already obtained in Study 160601. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).

BIOLOGICAL

Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)

Comprises all other subjects. Study Epoch 1: IV infusion of IGIV, 10% (same dose and frequency as pre-study) to determine pharmacokinetics. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-18
Primary Completion
2010-11-11
Completion
2010-11-11

Countries

  • United States
  • Canada

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 NCT00814320 on ClinicalTrials.gov