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Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID

NCT02810444 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-07-20

Study results available
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Summary

This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)

Conditions

  • Primary Immunodeficiency Disease

Interventions

BIOLOGICAL

IgG Next Generation (BT595)

Sponsors & Collaborators

Principal Investigators

  • Gergely Krivan, MD · Egyesitett Szent Istvan es Szent Laszlo Korhaz, Budapest, Hungary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-10-04
Primary Completion
2020-04-01
Completion
2020-04-01

Countries

  • United States
  • Germany
  • Hungary
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT02810444 on ClinicalTrials.gov