NCT02810444COMPLETEDanonymous

An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)

Sponsor

Source record

Biotest

Phase

Source record

PHASE3

Modality

AI-normalized

gene therapy

Target

AI-normalized

IgG Next Generation (BT595)

Indication / condition

AI-normalized

Primary Immunodeficiency Disease

Intervention

Source record

IgG Next Generation (BT595)

Related intelligence directories

Indication directory: Primary Immunodeficiency Disease Modality directory: gene therapy Target directory: IgG Next Generation (BT595)

Source & freshness

Source record

NCT ID

NCT02810444

Original source

ClinicalTrials.gov

Source last updated

Jul 20, 2023

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record

View original source fields

NCT ID

NCT02810444

Title

An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)

Sponsor

Biotest

Status

COMPLETED

Phase

PHASE3

Condition raw

Primary Immunodeficiency Disease

Condition normalized

Primary Immunodeficiency Disease

Modality raw

gene therapy

Modality normalized

gene therapy

Target raw

IgG Next Generation (BT595)

Target normalized

IgG Next Generation (BT595)

Interventions

IgG Next Generation (BT595)

Public preview

Source record

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

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 20, 2026

NCT ID

NCT02810444

Status

COMPLETED

Phase

PHASE3

Sponsor

Biotest

Executive brief

Investment-Ready Snapshot

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

Source & freshness

Provenance

SourceClinicalTrials.gov

Source updatedJul 20, 2023

Internal syncJun 11, 2026

Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT02810444

Indication

Primary Immunodeficiency Disease

Modality

gene therapy

Target

IgG Next Generation (BT595)

Intervention

IgG Next Generation (BT595)

Source record