Clinical trials: HLH
Healthy
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
Some women cannot have children because they cannot produce enough follicle stimulating hormone (FSH) and luteinising hormone (LH).
- Trial name
- NCT02317809
- Testing
- Liquid pergoveris, Freeze-dried pergoveris
- Where
- Germany
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women
This is a single center, open-label, randomized, parallel group, dose finding study to evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®), compared with urinary human chorionic gonadotrophin…
- Trial name
- NCT01735422
- Testing
- r-hFSH, r-hLH, u-hCG
- Where
- Canada
- Volunteers
- 67 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hemophagocytic Lymphohistiocytoses
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH
Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of several clinical conditions (e.g.
- Trial name
- NCT03985423
- Testing
- Emapalumab-Lzsg
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Swedish Orphan Biovitrum
Infertility
A Non-interventional Study to Identify the Patients With Severe Luteinizing Hormone Deficiency in the Daily Practice
This non-interventional study is planned to identify the subjects with severe luteinizing hormone (LH) deficiency in the daily practice.
- Trial name
- NCT01112618
- Where
- Germany
- Volunteers
- 3,247 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Reproductive Techniques, Assisted
Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle
The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) >3500 International Unit (IU), the…
- Trial name
- Luveris in ART (NCT01071200)
- Testing
- Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH), r-hFSH
- Where
- Italy
- Volunteers
- 133 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hemophagocytic Lymphohistiocytosis
Evaluation of IFNγ and Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis
This observational study is designed to determine the levels of pro-inflammatory markers in patients diagnosed with M-HLH, and to assess whether the cytokine profiles bear an IFNγ signature.
- Trial name
- NCT03259230
- Testing
- Blood Draws, Data Collection
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Swedish Orphan Biovitrum
Primary Hemophagocytic Lymphohistiocytosis
A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients
The goal of this post-authorization study is to describe safety and efficacy of emapalumab in treatment experienced Chinese patients with pHLH.
- Trial name
- NCT05744063
- Testing
- Emapalumab-Lzsg 5 MG/ML [Gamifant]
- Where
- 7 sites in China
- Volunteers
- 13 people
- Sponsor
- Swedish Orphan Biovitrum
Hypogonadism
A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation…
- Trial name
- NCT01084265
- Testing
- Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH), Human chorionic gonadotropin (hCG)
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis
A Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of Plonmarlimab in Subjects With Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis (Also Known as Macrophage Activation Syndrome [MAS])
A study designed to evaluate the efficacy, safety, immunogenicity, PK, and PD characteristics of Plonmarlimab in patients with relapsed/refractory rheumatic and immunologic disease-associated MAS, and to explore biomarkers…
- Trial name
- NCT07208058
- Testing
- Plonmarlimab
- Where
- 18 sites in China
- Volunteers
- 30 people
- Sponsor
- TJ Biopharma Co., Ltd.
Fertility
An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin
The purpose of this study is to assess the Pharmacokinetic (PK) of Recombinant human follicle-stimulating hormone (follitropin alfa) (r-hFSH) and Recombinant human luteinizing hormone (lutropin alfa) (r-hLH) following a single…
- Trial name
- NCT07269327
- Testing
- Desogestrel and ethinylestradiol fixed dose combination, Follitropin alfa/lutropin alfa
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.
- Conditions
- Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis, Inherited Bone Marrow Failure Syndrome, Hemoglobinopathies
- Trial name
- NCT02231710
- Testing
- BPX-501 and Rimiducid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Bellicum Pharmaceuticals
Septic Shock, Acute Respiratory Distress Syndrome
CytOSorb TreatMent Of Critically Ill PatientS Registry
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based…
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma, Rhabdomyolysis
- Trial name
- COSMOS (NCT05146336)
- Testing
- CytoSorb
- Where
- 28 sites in Austria, Germany and 4 more
- Volunteers
- 3,000 people
- Sponsor
- CytoSorbents, Inc
Primary Hemophagocytic Lymphohistiocytosis
Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis
The purpose of this study is to expand the knowledge on the efficacy and safety of emapalumab (previously known as NI-0501) as a treatment for primary haemophagocytic lymphohistiocytosis (HLH) patients, including on long-term…
- Trial name
- NCT03312751
- Testing
- Emapalumab
- Where
- 27 sites in United States, Canada and 6 more
- Volunteers
- 35 people
- Sponsor
- Swedish Orphan Biovitrum
Primary Haemophagocytic Lymphohistiocytosis
Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis
The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis.
- Trial name
- NCT01818492
- Testing
- NI-0501
- Where
- 20 sites in United States, Germany and 4 more
- Volunteers
- 45 people
- Sponsor
- Swedish Orphan Biovitrum
Infertility, Ovulation Induction
A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve
This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human…
- Trial name
- NCT01110707
- Testing
- Recombinant human follicle stimulating hormone (r-hFSH), Recombinant human luteinizing hormone (r-hLH)
- Where
- Spain
- Volunteers
- 131 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Macrophage Activation Syndrome, Lymphohistiocytosis, Hemophagocytic
A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)
Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset…
- Conditions
- Macrophage Activation Syndrome, Lymphohistiocytosis, Hemophagocytic, Arthritis, Juvenile, Adult Onset Still Disease
- Trial name
- NCT03311854
- Testing
- Emapalumab
- Where
- 5 sites in United States, France and 3 more
- Volunteers
- 14 people
- Sponsor
- Swedish Orphan Biovitrum
Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis…
- Conditions
- Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus
- Trial name
- EMERALD (NCT05001737)
- Testing
- Emapalumab
- Where
- 44 sites in United States, Belgium and 11 more
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophagocytic Lymphohistiocytosis
A Study for Long-term Follow-up of Hemophagocytic Lymphohistiocytosis (HLH) Participants Who Received Treatment With Emapalumab (NI-0501), an Anti-interferon Gamma Monoclonal Antibody
International, multicenter, long-term, follow-up study that will enrol HLH participants who have received emapalumab in previous clinical trials, in the context of the clinical development program for emapalumab or under…
- Trial name
- NCT02069899
- Testing
- Emapalumab
- Where
- 16 sites in United States, France and 3 more
- Volunteers
- 58 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophagocytic Lymphohistiocytoses
Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis
This observational study is designed to provide a better understanding of the potential use of interferon gamma (IFNγ) and IFNγ-inducible chemokines as markers of HLH disease activity in adults, and the potential of IFNγ to…
- Trial name
- NCT06047210
- Testing
- Blood Draws Data Collection
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Swedish Orphan Biovitrum
Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically…
- Trial name
- NCT05416307
- Testing
- ELA026
- Where
- 42 sites in United States, Austria and 5 more
- Volunteers
- 156 people
- Sponsor
- Electra Therapeutics Inc.