Clinical trials: Complement System
Hereditary Angioedema
C1-INH Compared to Placebo at the Time of Prodromal Symptoms for Hereditary Angioedema (HAE) Exacerbation
The study hypothesis is that treatment of Hereditary Angioedema at the time of prodromal symptoms will decrease morbidity associated with the disease
- Trial name
- NCT01151735
- Testing
- C-1-esterase
- Sponsor
- Penn State University
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment
The primary objective of this study will be to evaluate the pharmacokinetic properties of avacopan and its metabolite CCX168-M1 after a single oral dose of 30 mg avacopan in participants with mild or moderate hepatic impairment…
- Trial name
- NCT06004934
- Testing
- Avacopan
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
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
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study of CCX168 in Japanese and Caucasian Healthy Adult Males
The objectives of the study will be to investigate the safety and pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of CCX168 in Japanese healthy adult males; and to compare the…
- Trial name
- NCT05988008
- Testing
- CCX168
- Where
- Japan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Amgen
Hereditary Angioedema
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.
- Trial name
- NCT00432510
- Testing
- C1 esterase inhibitor [human] (C1INH-nf)
- Where
- 6 sites in United States
- Volunteers
- 27 people
- Sponsor
- Shire
Hereditary Angioedema
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in participants with HAE.
- Trial name
- NCT06634420
- Testing
- NTLA-2002, Normal Saline IV Administration
- Where
- 29 sites in United States, Australia and 7 more
- Volunteers
- 80 people
- Sponsor
- Intellia Therapeutics
Chronic Lymphocytic Leukemia
Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma
It has been shown that many patients with lymphoma or chronic lymphocytic leukemia (CLL)have low levels of complement. Several drugs have been approved by the Food and Drug Administration (FDA) for use in this cancer.
- Trial name
- NCT01716208
- Testing
- Ofatumumab + Fresh Frozen Plasma
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Joseph Tuscano
Trauma, Inflammation
Effect of C1-esterase Inhibitor on Systemic Inflammation in Trauma Patients With a Femur or Pelvic Fracture
Trauma and major operation are associated with an excessive inflammation reaction due to tissue injury. This overwhelming immune response is considered to be a major risk factor in the pathogenesis of late inflammatory…
- Conditions
- Trauma, Inflammation, Sepsis, Multiple Organ Dysfunction Syndrome
- Trial name
- CAESAR (NCT01275976)
- Testing
- C1-esterase inhibitor, Saline 0.9%
- Where
- Netherlands
- Volunteers
- 11 people
- Sponsor
- UMC Utrecht
Lupus Erythematosus, Lupus Erythematosus, Systemic
Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PL-AMD)
The rationale of this research is to determine if patients with lupus and presenting retinal "pseudo-drusen-like" deposits have genetic and complement-related similarities with AMD patients.
- Conditions
- Lupus Erythematosus, Lupus Erythematosus, Systemic, Age Related Macular Degeneration
- Trial name
- PL-AMD (NCT03504540)
- Testing
- Blood test
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
Hereditary Angioedema (HAE)
HAE Burden and Crisis Management
The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE).
- Trial name
- ECRINS (NCT06806618)
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Grenoble
Hereditary Angioedema (HAE)
A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema
This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure…
- Trial name
- NCT01541423
- Where
- 20 sites in Belgium, France and 4 more
- Volunteers
- 83 people
- Sponsor
- Shire
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.
Hereditary Angioedema (HAE)
A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt
Hereditary angioedema (HAE) is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels.
- Trial name
- EXPLORHAE (NCT07218393)
- Testing
- No intervention
- Where
- 7 sites in Egypt
- Volunteers
- 100 people
- Sponsor
- Takeda
Coronary Artery Bypass Grafting (CABG) Surgery, Myocardial Protection
Impact of Different Cardioplegia Solutions on Indicators of Myocardial Injury During Coronary Surgery
The aim of the present study is to investigate intra-operative changes in markers of myocardial injury during ischemia and reperfusion, comparing three methods of myocardial protection; St.
- Trial name
- Cardioplegia2 (NCT07358221)
- Testing
- The intervention is the use of a specific cardioplegia solution for myocardial protection
- Where
- Syria
- Volunteers
- 30 people
- Sponsor
- Damascus University
C3 Glomerulopathy, Membranoproliferative Glomerulonephritis
Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy
The aim of this cross-over trial is to assess aliskiren, a direct renin inhibitor, as a novel treatment to block complement activation in the kidneys and thereby attenuate renal disease and stabilize or improve kidney function…
- Conditions
- C3 Glomerulopathy, Membranoproliferative Glomerulonephritis, Complement Abnormality, Dense Deposit Disease
- Trial name
- NCT04183101
- Testing
- Aliskiren, Enalapril
- Where
- 4 sites in Sweden
- Volunteers
- 30 people
- Sponsor
- Region Skane
Hereditary Angioedema
Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)
This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE).
- Trial name
- NCT07654829
- Testing
- KVD900 600 mg
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants
The primary objective of this study is to perform mass balance following a single oral dose of [14C]CCX168 in healthy adult male participants.
- Trial name
- NCT06004960
- Testing
- [14C]CCX168
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Amgen
Systemic Lupus Erythematosus Nephritis
Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles
Lupus nephritis (LN) is a severe manifestation of systemic lupus erythematosus (SLE) that can lead to irreversible kidney damage if not detected and managed promptly.
- Trial name
- NCT06642402
- Testing
- Kidney biopsy, Urinary extracellular vesicle testing, Autoimmunity in plasma
- Where
- 4 sites in Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kolding Sygehus
Hereditary Angioedema
A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE
The objectives of the study were: 1. To assess the safety and tolerability of escalating doses of CINRYZE. 2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary angioedema (HAE) attack rates. 3.
- Trial name
- NCT00914966
- Testing
- C1 inhibitor (human) [C1 INH]
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Shire
C3G, IC-MPGN
C3G/Primary IC-MPGN EAP
This is an Early Access Program (EAP) which will provide access to pegcetacoplan for eligible participants with C3G and Primary IC-MPGN.
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis
- Trial name
- NCT04729062
- Testing
- Pegcetacoplan
- Sponsor
- Apellis Pharmaceuticals, Inc.