Clinical trials: Primary Immunodeficiencies
HIV Infection
TMC125-C223: TMC125 in HIV-1 Infected Subjects
The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered twice daily for 48 weeks.
- Trial name
- NCT00081978
- Testing
- TMC125
- Volunteers
- 211 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hereditary Angioedema (HAE)
Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)
The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze®…
- Trial name
- NCT01034969
- Where
- 74 sites in Australia, Austria and 12 more
- Volunteers
- 1,761 people
- Sponsor
- Shire
Primary Immune Deficiency Disorder
Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases
CLINICAL PHASE 3 STUDY TO MONITOR THE SAFETY, TOLERABILITY, AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (CUTAQUIG®) ADMINISTERED AT MODIFIED DOSING REGIMENS IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
- Trial name
- NCT03939533
- Testing
- CUTAQUIG
- Where
- 18 sites in United States
- Volunteers
- 64 people
- Sponsor
- Octapharma
Primary Immunodeficiency
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the…
- Trial name
- NCT04566692
- Testing
- IGSC 20%
- Where
- 12 sites in United States
- Volunteers
- 33 people
- Sponsor
- Grifols Therapeutics LLC
Hereditary Angioedema (HAE)
A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries
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 but does not cause itching or…
- Trial name
- NCT07251933
- Testing
- No intervention
- Where
- 24 sites in Argentina, France and 4 more
- Volunteers
- 37 people
- Sponsor
- Takeda
Hereditary Angioedema (HAE)
A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II
The main aim of this study is to compare the number of HAE attacks occuring in persons using lanadelumab with the number of HAE attacks before lanadelumab treatment was started.
- Trial name
- ENABLE (NCT04130191)
- Where
- 19 sites in Austria, Germany and 5 more
- Volunteers
- 140 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home
The main aim of this study is to describe the treatment patterns, characteristics and outcomes of people with HAE who are currently receiving icatibant in the homecare setting in the United Kingdom (UK).
- Trial name
- NCT05489640
- Testing
- No Intervention
- Where
- United Kingdom
- Volunteers
- 85 people
- Sponsor
- Takeda
Primary Immune Deficiency
An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)
This is a Phase IV, multicenter, open-label study of Asceniv™ administered as an intravenous infusion of Asceniv™ (IGIV) 300-800 mg/kg every 21 or 28 days in approximately 12 pediatric subjects with Primary Immunodeficiency…
- Trial name
- NCT05070455
- Testing
- Asceniv™
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- ADMA Biologics, Inc.
Hereditary Angioedema
Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat
The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Hereditary Angioedema (HAE) pediatric (ages 2-11) post-trial and naïve…
- Trial name
- NCT07216378
- Testing
- Sebetralstat
- Where
- 6 sites in United States
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Primary Immune Deficiency (PID)
Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P.
- Trial name
- NCT00405184
- Testing
- IntragamP, Ig NextGen 10%
- Where
- 4 sites in Australia
- Volunteers
- 19 people
- Sponsor
- CSL Limited
Primary Immunodeficiency
An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)
This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20.
- Trial name
- NCT07076446
- Testing
- IgPro
- Where
- 8 sites in United States
- Volunteers
- 8 people
- Sponsor
- CSL Behring
Hereditary Angioedema (HAE)
Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema
The primary objective of this study is: assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE The secondary objectives are: evaluate the pharmacokinetic profile of ecallantide in…
- Trial name
- NCT01253382
- Testing
- ecallantide
- Sponsor
- Shire
Hereditary Angioedema
Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema
The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial.
- Trial name
- NCT06415448
- Testing
- Donidalorsen
- Sponsor
- Ionis Pharmaceuticals, Inc.
Hereditary Angioedema, HAE
Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE who live in…
- Trial name
- APeX-J (NCT03873116)
- Testing
- BCX7353 capsules
- Where
- 10 sites in Japan
- Volunteers
- 19 people
- Sponsor
- BioCryst Pharmaceuticals
Hereditary Angioedema (HAE)
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of…
- Trial name
- NCT02052141
- Testing
- CINRYZE 500, CINRYZE 1000
- Where
- 8 sites in United States, Germany and 3 more
- Volunteers
- 12 people
- Sponsor
- Shire
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
Hereditary Angioedema (HAE)
A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in the Kingdom of Saudi Arabia
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.
- Trial name
- NCT07263685
- Testing
- No intervention
- Where
- Saudi Arabia
- Volunteers
- 50 people
- Sponsor
- Takeda
Hereditary Angioedema
Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002
This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.
- Trial name
- NCT06262399
- Where
- 7 sites in Australia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Intellia Therapeutics
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
Hereditary Angioedema
C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.
- Trial name
- NCT00289211
- Testing
- C1 esterase inhibitor [human] (C1INH-nf)
- Where
- 37 sites in United States
- Volunteers
- 83 people
- Sponsor
- Shire