Clinical trials: Antibody Deficiency
Primary Immune Deficiency Disorder
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
- Trial name
- NCT01814800
- Testing
- RI-002
- Where
- 9 sites in United States
- Volunteers
- 59 people
- Sponsor
- ADMA Biologics, Inc.
Primary Immunodeficiency Disease
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
- Trial name
- CARES10 (NCT03961009)
- Testing
- Kedrion IVIG 10%
- Where
- 11 sites in United States
- Volunteers
- 47 people
- Sponsor
- Kedrion S.p.A.
Human Immunodeficiency Virus Prevention, Human Immunodeficiency Virus (HIV)
Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults
Background: HIV stands for human immunodeficiency virus, which is the virus that causes AIDS. There is currently no licensed vaccine to prevent HIV infection.
- Trial name
- NCT03783130
- Testing
- VRC-HIVRGP096-00-VP, Alum Adjuvant
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acquired Hemophilia A
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A
This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with acquired hemophilia A.
- Trial name
- NCT01178294
- Testing
- OBI-1
- Where
- 12 sites in United States, Canada and 2 more
- Volunteers
- 29 people
- Sponsor
- Baxalta now part of Shire
Growth Hormone Deficiency (GHD)
Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
- Trial name
- NCT01237340
- Testing
- Saizen®
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- EMD Serono
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 Immunodeficiency Diseases (PID)
Gammagard Liquid and rHuPH20 in PID
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…
- Trial name
- NCT00814320
- Testing
- Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)
- Where
- 14 sites in United States, Canada
- Volunteers
- 89 people
- Sponsor
- Baxalta now part of Shire
Primary Immune Deficiency Disorders, Common Variable Immunodeficiency
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for…
- Conditions
- Primary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinaemia, Hyperimmunoglobulin M Syndrome
- Trial name
- SCIG03 (NCT01884311)
- Testing
- Subgam
- Where
- 16 sites in United States
- Volunteers
- 38 people
- Sponsor
- Bio Products Laboratory
Hypogammaglobulinemia, Lung Transplantation
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
- Trial name
- NCT00115778
- Testing
- IVIG
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Columbia University
HIV Infection, Hepatitis C
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons…
- Trial name
- NCT01285050
- Testing
- Antiretroviral therapy (ART), raltegravir, Emtricitabine and tenofovir disoproxil fumarate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Johns Hopkins University
Primary Immunodeficiency Diseases (PID)
Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
The purpose of the study is to acquire additional data on safety and tolerability of recombinant human hyaluronidase (rHuPH20) facilitated subcutaneous treatment of Immune Globulin Infusion (Human), 10% (IGI, 10%) and to assess…
- Trial name
- NCT01485796
- Testing
- Immune Globulin Infusion (Human), 10%, Recombinant human hyaluronidase
- Where
- 10 sites in United States
- Volunteers
- 54 people
- Sponsor
- Baxalta now part of Shire
Primary Immune Deficiency Disorders (PIDD)
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
The purpose of this study is to determine if NABI-IGIV (10%) [Immune Globulin Intravenous (Human), 10%] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune…
- Trial name
- NCT00538915
- Testing
- Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
- Where
- 17 sites in United States
- Volunteers
- 63 people
- Sponsor
- ADMA Biologics, Inc.
HIV Infections, Cytomegalovirus Retinitis
Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as adjunct therapy for controlling CMV retinitis.
- Trial name
- MACRT (NCT00000135)
- Testing
- MSL-109
- Volunteers
- 209 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HTLV-I Infection, T Cell Leukemia
Anti-Tac for Treatment of Leukemia
The purpose of the study was to determine: (1) the toxicity and maximum tolerated dose (MTD) of humanized anti-Tac (daclizumab), (Zenapax(Registered Trademark)) in patients with adult T-cell leukemia/lymphoma (ATL); (2) to define…
- Trial name
- NCT00001941
- Testing
- daclizumab
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- National Cancer Institute (NCI)
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
Primary Immunodeficiency Disease
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
- Trial name
- NCT02810444
- Testing
- IgG Next Generation (BT595)
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 81 people
- Sponsor
- Biotest
Colorectal Tumors, Colorectal Neoplasms
Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in People With Previously Untreated Metastatic Colorectal Cancer QUILT-2.004
Background: Colorectal cancer is a common cancer in the Unites States (U.S.) It causes the second most cancer-related deaths. The drug avelumab and vaccine Ad-CEA together help the immune system fight cancer.
- Conditions
- Colorectal Tumors, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Adenocarcinoma
- Trial name
- NCT03050814
- Testing
- Avelumab, Ad-CEA vaccine, Bevacizumab
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Cancer Institute (NCI)
HIV-associated Enteropathy
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient…
- Trial name
- NCT01828593
- Testing
- Serum-derived bovine immunoglobulin protein isolate (SBI)
- Where
- 10 sites in United States
- Volunteers
- 103 people
- Sponsor
- Entera Health, Inc
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
Household Contacts
A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.
This study will include male and female participants who live or work in the same household as a patient in one of the fordadistrogene movaparvovec interventional studies.
- Trial name
- NCT04543357
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer