Clinical trials: Human Development
Tuberculosis
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial…
- Trial name
- NCT05592223
- Testing
- BCG Vaccine USP, Isoniazid, Rifampin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
Hypogonadotropic Hypogonadism
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
- Trial name
- NCT00328926
- Testing
- Luveris® 75 IU, Luveris® 25 IU, Recombinant human follicle stimulating hormone (r-hFSH)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- EMD Serono
Childhood-onset Growth Hormone Deficiency, Pituitary Dwarfism
Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to…
- Trial name
- NCT00109733
- Testing
- recombinant human growth hormone
- Where
- 9 sites in United States
- Volunteers
- 31 people
- Sponsor
- EMD Serono
Autism Spectrum Disorder
Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD)
The main purpose of this study is to evaluate safety and tolerability in a subgroup of patients with Autism Spectrum Disorder (ASD).
- Trial name
- NCT04644003
- Testing
- STP1
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stalicla SA
Infertility
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising…
- Trial name
- ESPART (NCT02047227)
- Testing
- Pergoveris®, GONAL-f®, Recombinant human chorionic gonadotrophin (r-hCG)
- Where
- Germany
- Volunteers
- 939 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Hormone Deficiency (GHD)
Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Protocol CP-4-004-OLE (Open Label Extension) is designed as a long-term, open-label extension using single patient use, multi-dose, disposable pre-filled pen.
- Trial name
- NCT02500316
- Testing
- MOD-4023
- Where
- 13 sites in United States, Belarus and 4 more
- Volunteers
- 48 people
- Sponsor
- OPKO Health, Inc.
Infant Development, Stress
Multisensory Early Oral Administration of Human Milk in Preterm Infants
The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation.
- Trial name
- M-MILK (NCT06230848)
- Testing
- Multisensory Early Oral Administration of Human Milk (M-MILK)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Loyola University
Hepatitis C, Chronic Kidney Diseases
Helping Empower Liver and Kidney Patients
The overall purpose of this study is to develop and test a web-based decision aid (DA) to support patients with Hepatitis C and Chronic Kidney Disease during decisions about whether, when, and how to treat each illness.
- Conditions
- Hepatitis C, Chronic Kidney Diseases, Patient Education
- Trial name
- Project HELP (NCT03426787)
- Testing
- Decision Aid
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Washington University School of Medicine
Hypogonadism, Kallmann Syndrome
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism
Men with idiopathic hypogonadotropic hypogonadism (IHH, Kallmann Syndrome) may have small testicular size, low testosterone levels, no history of puberty, and infertility.
- Trial name
- NCT00064987
- Testing
- Testicular biopsy, gonadotropin releasing hormone (GnRH), follicle stimulating hormone (FSH)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Infectious Diseases, Influenza
Development of Immune Globulin Treatment for Avian Flu
This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza…
- Conditions
- Infectious Diseases, Influenza, Avian Flu
- Trial name
- NCT00383071
- Testing
- H5N1 vaccine, Apheresis
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Respiratory Syncytial Virus Infections, Respiratory Viral Infections
The Development of a Human Model of Respiratory Syncytial Virus Infection
The aim of this study is to understand the immune response (how the body fights infection) to Respiratory Syncytial Virus (RSV).
- Trial name
- NCT01349543
- Testing
- RSV A Memphis 37
- Where
- United Kingdom
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Occupational Therapy, Psychiatric Rehabilitation
Development and Validation of the Client Centered Occupational Therapy Service Model
The purpose of the study is to develop and validate Client-centered Occupational Therapy Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and integrate comprehensive OT services.
- Trial name
- NCT04465422
- Testing
- Occupational therapy based on the MOHO theory, Occupational therapy
- Where
- Taiwan
- Volunteers
- 33 people
- Sponsor
- Taipei City Hospital
Hypofibrinogenemia, Afibrinogenemia
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
- Conditions
- Hypofibrinogenemia, Afibrinogenemia, Bleeding Disorders
- Trial name
- RiaSTAP (NCT02822599)
- Testing
- RiaStAP, Saline
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Adult Growth Hormone Deficiency, Endocrine System Diseases
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly.
- Conditions
- Adult Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
- Trial name
- NCT05171855
- Testing
- Lonapegsomatropin
- Where
- 85 sites in United States, Armenia and 19 more
- Volunteers
- 220 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Infection, Human Immunodeficiency Virus, HIV Infections
GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers
Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play.
- Trial name
- NCT03231943
- Testing
- GSK3640254
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Polycystic Ovarian Syndrome
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from…
- Trial name
- ATTAC-PCO (NCT01185704)
- Testing
- Cetrorelix acetate, Recombinant Human Choriogonadotropin (r-hCG), Recombinant human follicle stimulating hormone (r-hFSH)
- Where
- France
- Volunteers
- 136 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Kaposi Sarcoma, Human Immunodeficiency Virus
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
Kaposi sarcoma (KS) has an unpredictable course, patients with disseminated KS starting combined Antiretroviral Therapy can develop Immune Reconstitution Syndrome (IRIS), with a severe clinical presentation and high mortality…
- Conditions
- Kaposi Sarcoma, Human Immunodeficiency Virus, Immune Reconstitution Syndrome
- Trial name
- NCT03296553
- Testing
- Valganciclovir, Antiretroviral Combinations
- Where
- Mexico
- Volunteers
- 40 people
- Sponsor
- National Institute of Cancerología
Idiopathic Growth Hormone Deficiency, Turner Syndrome
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study
PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner…
- Trial name
- NCT01419249
- Testing
- Blood sampling
- Where
- 31 sites in Argentina, Canada and 7 more
- Volunteers
- 458 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Rett Syndrome
Treatment of Rett Syndrome With Recombinant Human IGF-1
Investigators are recruiting children for a clinical trial using the medication recombinant human IGF-1 (a.k.a. mecasermin or INCRELEX) to see if it improves the health of children with Rett syndrome (RTT).
- Trial name
- NCT01777542
- Testing
- Recombinant Human Insulin Growth Factor 1 (rhIGF-1)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Boston Children's Hospital
Growth Hormone Deficiency (GHD)
Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis.
- Trial name
- NCT01947907
- Testing
- ACP-001, Human Growth Hormone
- Where
- 36 sites in Belarus, Bulgaria and 12 more
- Volunteers
- 53 people
- Sponsor
- Ascendis Pharma A/S