Octagam 5% Versus Comparator Post Marketing Trial
NCT01859754 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 623
Last updated 2019-06-10
Summary
Study Design:
This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments.
Conditions
- Primary Immune Deficiency Disorder
Interventions
- BIOLOGICAL
-
Octagam 5%
Intravenous immunoglobulin 5%
- BIOLOGICAL
-
Other marketed IVIG product
Any intravenous immunoglobulin marketed product approved for the treatment of PID
Sponsors & Collaborators
-
Octapharma
lead INDUSTRY
Principal Investigators
-
Wolfgang Frenzel · International Medical Monitor, Octapharma AG
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-21
- Primary Completion
- 2019-05-22
- Completion
- 2019-05-22
Countries
- United States
Study Locations
More Related Trials
-
Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG
NCT06089122 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants
NCT04578535 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
NCT01544361 ·Status: COMPLETED ·Phase: PHASE1
-
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
NCT06565078 ·Status: RECRUITING
-
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
NCT00498654 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
NCT05074433 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of the Safety and Efficacy of EBV Specific T-cell Lines
NCT02580539 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease
NCT05081388 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Outpatient Treatment With Anti-Coronavirus Immunoglobulin
NCT04910269 ·Status: RECRUITING ·Phase: PHASE3
-
NasoShield in Healthy Adults to Study Safety and Immunogenicity
NCT04415749 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers
NCT01081691 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C in Population Aged ≥18 Years and Previously Fully Vaccinated With COVID-19 Vaccine
NCT05238454 ·Status: UNKNOWN ·Phase: PHASE2
-
A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults
NCT02564237 ·Status: UNKNOWN ·Phase: PHASE1
-
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I )
NCT04442178 ·Status: TERMINATED ·Phase: PHASE2
-
Anti COVID 19 Hyperimmune Intravenous Immunoglobulin (C-IVIG) Therapy for Severe COVID-19 Patients
NCT04891172 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
NCT00002059 ·Status: COMPLETED ·Phase: NA
-
Ad26.COV2.S as a Heterologous Booster in Adults After Single- or Two-Dose of Inactivated COVID-19 Vaccine
NCT05109559 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
NCT05505448 ·Status: COMPLETED ·Phase: PHASE1
-
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
NCT00002061 ·Status: COMPLETED ·Phase: NA
-
IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation
NCT04616001 ·Status: UNKNOWN ·Phase: PHASE4
-
The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
NCT00002296 ·Status: COMPLETED ·Phase: NA
-
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine
NCT05238441 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
NCT04785144 ·Status: COMPLETED ·Phase: PHASE1
-
A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine
NCT05652543 ·Status: COMPLETED ·Phase: PHASE2
-
Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections
NCT03159364 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2