Clinical trials: Pregnancy
Fabry Disease
Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
This was a randomized, double-blind, active control study of the enzyme replacement therapy (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function.
- Trial name
- BALANCE (NCT02795676)
- Testing
- PRX-102 (pegunigalsidase alfa), agalsidase beta
- Where
- 29 sites in United States, Czechia and 10 more
- Volunteers
- 78 people
- Sponsor
- Protalix
Renal Impairment
Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose
The primary objectives of this study are: 1. To obtain information on the pharmacokinetics of cytisinicline following a single oral dose in subjects with varying degrees of renal impairment relative to matched controls with…
- Trial name
- NCT05631938
- Testing
- cytisinicline
- Where
- 6 sites in Portugal, Spain
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Achieve Life Sciences
End-Stage Renal Disease (ESRD)
A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
The primary objective of the study is to evaluate the pharmacokinetics (PK) of avacopan and metabolite (M1) after a single dose of avacopan in participants with normal renal function and participants with ESRD requiring…
- Trial name
- NCT06468826
- Testing
- Avacopan
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Amgen
Advanced Solid Tumor, Metastatic Cancer
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007, also known as imneskibart, in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer
- Trial name
- NCT05267626
- Testing
- AU-007, Aldesleukin, Avelumab
- Where
- 17 sites in United States, Australia
- Volunteers
- 159 people
- Sponsor
- Aulos Bioscience, Inc.
Cancer, Solid Tumor
Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors
This study will evaluate safety, pharmacodynamics and biomarkers of subcutaneous (SC) DK210(EGFR) given as monotherapy and in combination with immunotherapy, chemotherapy or radiation.
- Conditions
- Cancer, Solid Tumor, Colorectal Cancer, Pancreas Cancer
- Trial name
- NCT05704985
- Testing
- DK210 (EGFR), Radiation therapy, Immune checkpoint blockers
- Where
- 7 sites in United States
- Volunteers
- 39 people
- Sponsor
- DEKA Biosciences
Chronic Kidney Disease, End Stage Renal Failure on Dialysis
Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients
The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.
- Conditions
- Chronic Kidney Disease, End Stage Renal Failure on Dialysis, Anemia
- Trial name
- NCT02506868
- Testing
- Darbepoetin alfa
- Where
- 30 sites in Russia
- Volunteers
- 196 people
- Sponsor
- Biocad
PTCH1 or SMO Activated Solid and Hematologic Tumors
LDE225 for Patients With PTCH1 or SMO Mutated Tumors
The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study
- Trial name
- SIGNATURE (NCT02002689)
- Testing
- LDE225
- Where
- 10 sites in United States
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Growth Hormone Deficiency, Idiopathic Short Stature
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
- Conditions
- Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age
- Trial name
- NCT04798690
- Where
- South Korea
- Volunteers
- 5,000 people
- Sponsor
- Dong-A ST Co., Ltd.
Breast Cancer, Endometrial Cancer
A Study of LY353381 (Arzoxifene) for Patients Who Benefitted From This Drug in Other Oncology Trials and Wished to Continue Treatment
Patients who were previously enrolled on the LY353381 arm of any LY353381 oncology trial could enroll in this "roll-over" study if they had exhibited clinical benefit from treatment and wished to continue on treatment.
- Conditions
- Breast Cancer, Endometrial Cancer, Ovarian Cancer
- Trial name
- NCT00190697
- Testing
- arzoxifene
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Eli Lilly and Company
High-risk Muscle Invasive Urothelial Carcinoma
An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.
- Trial name
- TU-04 (NCT07720284)
- Testing
- Dato-DXd, Rilvegostomig, Durvalumab
- Where
- 160 sites in United States, Australia and 14 more
- Volunteers
- 915 people
- Sponsor
- AstraZeneca
Gastric Adenocarcinoma, Esophageal Cancer
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial…
- Conditions
- Gastric Adenocarcinoma, Esophageal Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer
- Trial name
- NCT01631552
- Testing
- Sacituzumab Govitecan-hziy (SG)
- Where
- 12 sites in United States
- Volunteers
- 515 people
- Sponsor
- Gilead Sciences
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
Obstetric Labour, Premature
This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.
This will be a randomized, placebo-controlled, single, oral dose, four-way Williams crossover study design in healthy male and female subjects.
- Trial name
- NCT01702376
- Testing
- Retosiban 100 mg, Retosiban 800 mg, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria in Pregnancy, Pregnancy
Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP)
AZITHROMYCIN VERSUS SULPHADOXINE-PYRIMETHAMINE FOR PROPHYLAXIS AGAINST MALARIA IN PREGNANCY IN OWO, SOUIHWESTERN NIGERIA: A RANDOMISED CONTROLLED TRIAL OBJECTIVE: This study is to compare the efficacy of Azithromycin versus…
- Trial name
- NCT03944317
- Testing
- Sulfadoxine pyrimethamine, Azithromycin
- Where
- Nigeria
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Federal Medical Centre, Owo
Chronic Kidney Diseases, Inflammation
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Patients with chronic kidney disease, who have evidence of systemic inflammation with increased cardiovascular risk, will be enrolled into this trial.
- Trial name
- RESCUE (NCT03926117)
- Testing
- Ziltivekimab
- Where
- 49 sites in United States
- Volunteers
- 264 people
- Sponsor
- Novo Nordisk A/S
Heavy Menstrual Bleeding, Uterine Fibroids
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT03271489
- Testing
- Elagolix, Estradiol /norethindrone acetate (E2/NETA)
- Where
- 157 sites in United States, Puerto Rico
- Volunteers
- 478 people
- Sponsor
- AbbVie
Endometriosis
Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis
This study will investigate the clinical performance and diagnostic accuracy of the Mitomic® Endometriosis Test (MET) compared to laparoscopic diagnosis in a prospective clinical study in females presenting with symptoms…
- Trial name
- NCT06907550
- Testing
- The Mitomic Endometriosis Test (MET) blood test for early detection of endometriosis
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Pearsanta, Inc
Aneuploidy, Chromosome Abnormality
RCT Study to Validate niPGT-A Clinical Benefit.
Chromosomal aneuploidies are linked with spontaneous miscarriages and abnormal offspring in human pregnancies. In addition, some types of aneuploidies are reported to prevent implantation.
- Conditions
- Aneuploidy, Chromosome Abnormality, Infertility
- Trial name
- niPGT-A_RCT (NCT04000152)
- Testing
- niPGT-A, Morphology criteria
- Where
- 8 sites in Argentina, Brazil and 3 more
- Volunteers
- 296 people
- Sponsor
- Igenomix
Randomized, Open-label
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial…
- Conditions
- Randomized, Open-label, Safety, Tolerability
- Trial name
- NCT07663838
- Testing
- GenSci142 capsule, clindamycin phosphate vaginal cream
- Where
- 9 sites in China
- Volunteers
- 42 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Alport Syndrome
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome.
- Trial name
- CARDINAL (NCT03019185)
- Testing
- Bardoxolone Methyl
- Where
- 63 sites in United States, Australia and 6 more
- Volunteers
- 187 people
- Sponsor
- Biogen
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