Clinical trials: completed, sponsored by CSL Behring
Includes: Hereditary Angioedema
Patient Registry Study of Berinert® in Normal Clinical Practice
The objective of this patient registry is to collect data on the safety of Berinert® in normal clinical practice in the United States. The patient registry will be maintained for a period of at least 3 years.
- Trial name
- NCT01108848
- Testing
- Berinert® (C1 Esterase Inhibitor)
- Where
- 40 sites in United States, Denmark and 2 more
- Volunteers
- 318 people
- Sponsor
- CSL Behring
Primary Immunodeficiency (PID)
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.
- Trial name
- NCT00751621
- Testing
- IgPro20
- Where
- 13 sites in France, Germany and 6 more
- Volunteers
- 40 people
- Sponsor
- CSL Behring
Primary Immune Deficiency
Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.
- Trial name
- NCT00719680
- Testing
- IgPro20
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- CSL Behring
Blood Coagulation Disorders, Acute Major Bleeding
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate…
- Trial name
- NCT00708435
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 69 sites in United States, Belarus and 4 more
- Volunteers
- 216 people
- Sponsor
- CSL Behring
Hemophilia A
Health Related Quality of Life of Youth and Young Adults With Hemophilia A
The relevance of the study will be in establishing whether Health Related Quality of Life (HRQoL) measures obtained repeatedly during hemophilia care are sensitive to significant changes in health or personal circumstances…
- Trial name
- NCT01034904
- Where
- 2 sites in Canada
- Volunteers
- 48 people
- Sponsor
- CSL Behring
Aortic Aneurysm
Haemocomplettan® P During Aortic Replacement
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
- Trial name
- NCT00701142
- Testing
- Haemocomplettan® P, Saline solution
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- CSL Behring
Multifocal Motor Neuropathy (MMN)
A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)
The objective of this study is to assess efficacy, safety, and convenience of purified human antibodies administered under the skin in the treatment of MMN patients.
- Trial name
- NCT00701662
- Testing
- Vivaglobin
- Where
- 3 sites in Italy, Switzerland and 1 more
- Volunteers
- 8 people
- Sponsor
- CSL Behring
Common Variable Immunodeficiency, Agammaglobulinemia
Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period.
- Trial name
- NCT00520494
- Testing
- Vivaglobin
- Where
- 6 sites in Canada, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- CSL Behring
Primary Immune Deficiency Disorder
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).
- Trial name
- NCT01458171
- Testing
- Immune globulin subcutaneous (Human)
- Where
- 9 sites in Japan
- Volunteers
- 23 people
- Sponsor
- CSL Behring
Hereditary Angioedema Types I and II
A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor
A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert.
- Trial name
- NCT01760343
- Testing
- Berinert, CSL830
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Primary Immune Deficiency
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
- Trial name
- NCT00419341
- Testing
- Human Normal Immunoglobulin for Subcutaneous Administration
- Where
- 13 sites in United States
- Volunteers
- 49 people
- Sponsor
- CSL Behring
Agammaglobulinemia, IgG Deficiency
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates.
- Conditions
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
- Trial name
- NCT00322556
- Testing
- Immunoglobulins Intravenous (Human)
- Where
- 10 sites in United States
- Volunteers
- 55 people
- Sponsor
- CSL Behring
Factor XIII Deficiency
An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII.
- Trial name
- NCT00945906
- Testing
- FXIII Concentrate (Human) (FXIII)
- Where
- 25 sites in United States
- Volunteers
- 61 people
- Sponsor
- CSL Behring
Factor XIII Deficiency
A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Congenital deficiency of factor XIII (FXIII) is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII.
- Trial name
- NCT00885742
- Testing
- FXIII Concentrate (Human)
- Where
- 23 sites in United States, Spain
- Volunteers
- 41 people
- Sponsor
- CSL Behring
Agammaglobulinemia, IgG Deficiency
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.
- Conditions
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
- Trial name
- NCT00168025
- Testing
- Immunoglobulins Intravenous (Human)
- Volunteers
- 89 people
- Sponsor
- CSL Behring
Cystic Fibrosis
Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.
- Trial name
- NCT01347190
- Testing
- CR002 Liquid API
- Where
- 11 sites in Bulgaria, Hungary and 2 more
- Volunteers
- 25 people
- Sponsor
- CSL Behring
Hemophilia B
Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B
The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time.
- Trial name
- NCT01233440
- Testing
- Recombinant Coagulation Factor IX Albumin Fusion Protein, Plasma derived FIX [pdFIX]
- Where
- 20 sites in Austria, France and 4 more
- Volunteers
- 25 people
- Sponsor
- CSL Behring
Factor XIII Deficiency
A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency
Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with potentially life-threatening bleeding.
- Trial name
- NCT00883090
- Testing
- FXIII Concentrate (Human)
- Where
- 6 sites in United States, Spain
- Volunteers
- 15 people
- Sponsor
- CSL Behring
Immune Thrombocytopenic Purpura
Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP).
- Trial name
- NCT00168038
- Testing
- Immunoglobulin Intravenous (Human)
- Where
- 17 sites in Germany, Italy and 4 more
- Volunteers
- 58 people
- Sponsor
- CSL Behring
Common Variable Immunodeficiency, X-linked Agammaglobulinemia
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
- Conditions
- Common Variable Immunodeficiency, X-linked Agammaglobulinemia, Autosomal Recessive Agammaglobulinemia
- Trial name
- NCT00542997
- Testing
- Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)
- Where
- 19 sites in France, Germany and 7 more
- Volunteers
- 51 people
- Sponsor
- CSL Behring