Clinical trials: Complement System
Hereditary Angioedema (HAE)
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in…
- Trial name
- NCT01386658
- Testing
- icatibant
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 32 people
- Sponsor
- Shire
Angioedema, Angioedemas, Hereditary
Angioedema Biomarker Research Study
This clinical trial aims to evaluate and compare novel and commercially available diagnostic assays through blood tests for the differential diagnosis and comprehensive assessment of patients experiencing recurrent angioedema…
- Conditions
- Angioedema, Angioedemas, Hereditary, Urticaria, Mastocytosis
- Trial name
- NCT06210698
- Testing
- Venipuncture
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Foundation For Rare Disease Research
C3 Glomerulopathy, C3 Glomerulonephritis
A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
The primary purpose of this proof-of-concept clinical study was to evaluate the efficacy and safety of the study drug, ACH-0144471 (also known as danicopan and ALXN2040), in participants with C3G who also had significant…
- Conditions
- C3 Glomerulopathy, C3 Glomerulonephritis, Dense Deposit Disease
- Trial name
- NCT03369236
- Testing
- Danicopan
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Vasculitis
The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children
Vasculitis denotes affection of small to medium sized vessels by polyangitis. Antineutrophil cytoplasmic antibodies (ANCA) are immunoglobulin G (IgG) autoantibodies directed against constituents of neutrophil granules leading to…
- Trial name
- NCT03692416
- Testing
- Ibuprofen, Prednisone, Methotrexate
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Assiut University
Hereditary Angioedema
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).
- Trial name
- NCT00912093
- Testing
- Icatibant
- Where
- 64 sites in United States, Australia and 7 more
- Volunteers
- 98 people
- Sponsor
- Shire
Hereditary Angioedema
Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE
The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.
- Trial name
- OPuS-1 (NCT01984788)
- Testing
- BCX4161
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 24 people
- Sponsor
- BioCryst Pharmaceuticals
Complement 3 Glomerulopathy
A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain
This study aims to characterize the patient profiles and the clinical experience of iptacopan treatment in adult patients with C3G treated through an early access program (EAP) in Spain.
- Trial name
- ROUTE-C3G (NCT07598448)
- Where
- 2 sites in Spain
- Volunteers
- 35 people
- Sponsor
- Novartis Pharmaceuticals
Bullous Pemphigoid
Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)
A phase III two-part study of nomacopan, a bifunctional inhibitor of complement component C5 and leukotriene B4 (LTB4), for the treatment of moderate and severe bullous pemphigoid.
- Trial name
- ARREST-BP (NCT05061771)
- Testing
- nomacopan (rVA576)
- Where
- 12 sites in United States, Germany and 2 more
- Sponsor
- AKARI Therapeutics
Hereditary Angioedema (HAE)
CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12
The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in…
- Trial name
- NCT01095510
- Testing
- CINRYZE
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 9 people
- Sponsor
- Shire
Kidney Transplant
Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)
The purpose of this study is to find out if Berinert can improve kidney function in the first year after transplant and to find out what effects, good or bad, Berinert will have in the kidney recipient.
- Trial name
- IMPROVE (NCT06919003)
- Testing
- Berinert
- Where
- 4 sites in United States
- Volunteers
- 180 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hereditary Angioedema
Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients
This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including…
- Trial name
- NCT01359969
- Testing
- rhC1INH
- Where
- 16 sites in United States, Czechia and 8 more
- Volunteers
- 57 people
- Sponsor
- Pharming Technologies B.V.
Hereditary Angioedema
An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates
This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects.
- Trial name
- NCT02819102
- Testing
- BCX7353 and probes
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Hereditary Angioedema
A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema
The main aim of the study is to check for side effects from icatibant in children and teenagers with hereditary angioedema (HAE).
- Trial name
- NCT04654351
- Testing
- TAK-667
- Where
- 3 sites in Japan
- Volunteers
- 2 people
- Sponsor
- Takeda
Hereditary Angioedema (HAE)
Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE).
- Trial name
- APeX-1 (NCT02870972)
- Testing
- BCX7353
- Where
- 24 sites in Australia, Austria and 9 more
- Volunteers
- 75 people
- Sponsor
- BioCryst Pharmaceuticals
Hereditary Angioedema
A Study of the Burden of Illness and Treatment Patterns in Teenagers and Adults With Hereditary Angioedema
This study is about teenagers and adults with hereditary angioedema (HAE) type I and type II. In this study, the burden of illness means the impact of HAE in terms of long-term health outcomes and the financial cost.
- Trial name
- BOISTERN (NCT04957641)
- Where
- 36 sites in Austria, Belgium and 20 more
- Volunteers
- 221 people
- Sponsor
- Takeda
Hereditary Angioedema (HAE)
Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to…
- Trial name
- CHAPTER-3 (NCT06669754)
- Testing
- Deucrictibant
- Where
- 56 sites in United States, Argentina and 22 more
- Volunteers
- 81 people
- Sponsor
- Pharvaris Netherlands B.V.
Myasthenia Gravis Generalised, Vaccination
Meningococcal Vaccination in Patients on Complement Inhibitors
Myasthenia gravis is an autoimmune neurological disorder caused by autoantibodies directed predominantly against components of the postsynaptic membrane of the neuromuscular junction.
- Conditions
- Myasthenia Gravis Generalised, Vaccination, Complement System, Neuromyelitis Optica Spectrum Disease (NMOSD)
- Trial name
- Vax_MenACWY (NCT06906692)
- Testing
- Serum Bactericidal Assay
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Complement Deficiency, Antibody Deficiency
Systematic Search for Primary Immunodeficiency in Adults With Infections
Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections …
- Conditions
- Complement Deficiency, Antibody Deficiency, Chronic Sinus Infection, Meningitis, Bacterial
- Trial name
- SPIDAC (NCT02972281)
- Testing
- Immunological diagnosis tests
- Where
- 19 sites in France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Lille
C3G, IC-MPGN
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
This is a Phase 3 study to assess the efficacy and safety of twice-weekly subcutaneous (SC) doses of pegcetacoplan compared to placebo in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative…
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis
- Trial name
- VALIANT (NCT05067127)
- Testing
- Pegcetacoplan
- Where
- 125 sites in United States, Argentina and 17 more
- Volunteers
- 124 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Glomerulopathy, C3G
Pilot STUDY to Monitor Ex-vivo the Biological Effects of the C3 Inhibitor, PEGCETACOPLAN, on Activation of Complement in Fluid Phase and on Podocytes in Patients With C3G and Primary IC-MPGN
This is a prospective, multicenter, non-interventional, observational pharmacological real-world study to characterize longitudinal changes in ex vivo biomarkers of complement activation in patients with C3G and primary IC-MPGN…
- Conditions
- Glomerulopathy, C3G, Membranoproliferative Glomerulonephritis (MPGN)
- Trial name
- COMPASS (NCT07904338)
- Testing
- Blood sample
- Where
- Italy
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research