Clinical trials: Phase 4
Chronic Graft Versus Host Disease
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.
- Trial name
- NCT07135973
- Testing
- Belumosudil
- Volunteers
- 26 people
- Sponsor
- Sanofi
Severe Hemophilia A, Moderate Hemophilia A
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and <70 years…
- Trial name
- Beyond ABR (NCT05181618)
- Testing
- Emicizumab
- Where
- 26 sites in United States, Brazil and 10 more
- Volunteers
- 136 people
- Sponsor
- Hoffmann-La Roche
Muscular Atrophy, Spinal
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with SMA and 2 SMN2 copies who previously received onasemnogene…
- Trial name
- HINALEA 2 (NCT05861999)
- Testing
- Risdiplam
- Where
- 17 sites in United States, Germany and 4 more
- Volunteers
- 19 people
- Sponsor
- Hoffmann-La Roche
Spinal Muscular Atrophy
Long-term Follow-up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA)
A multi-center, longitudinal, prospective, non-comparative study to investigate the long-term safety and effectiveness of risdiplam, prescribed based on clinician judgment as per the Evrysdi® U.S.
- Trial name
- WeSMA (NCT05232929)
- Testing
- Risdiplam
- Where
- 38 sites in United States, Puerto Rico
- Volunteers
- 403 people
- Sponsor
- Genentech, Inc.
Edema Due to Heart Failure or Cirrhosis
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
This is a 2-part, 2 periods per part, open-label study with spironolactone oral suspension in pediatric patients with edema due to HF or hepatic cirrhosis.
- Trial name
- NCT06021860
- Testing
- Spironolactone Oral Suspension
- Volunteers
- 96 people
- Sponsor
- CMP Development, LLC
Malnutrition, Child, Malnutrition
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.
- Conditions
- Malnutrition, Child, Malnutrition, Essential Fatty Acid Deficiency (EFAD), Parenteral Nutrition Associated Cholestasis
- Trial name
- NCT06049680
- Testing
- SMOFlipid® (lipid injectable emulsion)
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Fresenius Kabi
Primary Myelofibrosis, Polycythemia Vera
CINC424A2X01B Rollover Protocol
This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study…
- Conditions
- Primary Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease, Acute Myeloid Leukemia
- Trial name
- NCT02386800
- Testing
- ruxolitinib, panobinostat
- Where
- 97 sites in Australia, Belgium and 23 more
- Volunteers
- 279 people
- Sponsor
- Novartis Pharmaceuticals
HIV-1-infection
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and…
- Trial name
- NCT06337032
- Testing
- F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet), F/TAF (Lowest Dose Tablet)
- Where
- 15 sites in Argentina, Panama and 4 more
- Volunteers
- 350 people
- Sponsor
- Gilead Sciences
Atopic Dermatitis
A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden
The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy.
- Trial name
- ADsolve (NCT07006792)
- Testing
- Lebrikizumab
- Where
- 66 sites in United States, Argentina and 3 more
- Volunteers
- 233 people
- Sponsor
- Eli Lilly and Company
COVID-19
Study of a Recombinant Spike COVID-19 Vaccine With Matrix-M in Older Adults and People at Increased Risk of Severe COVID-19
The purpose of this study is to evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants ≥ 65 years of age and participants 12 through 64 years of age who have at…
- Trial name
- NCT07861542
- Testing
- Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M
- Where
- 20 sites in United States
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Sanofi
Factor VIII Deficiency
Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants…
- Trial name
- SYNOVIIIUS (NCT06941870)
- Testing
- Efanesoctocog alfa
- Where
- 14 sites in United States, Canada and 2 more
- Volunteers
- 35 people
- Sponsor
- Sanofi
Autoimmunity, Inflammation
Secukinumab Open Label Roll-over Extension Protocol
The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are…
- Trial name
- NCT04638647
- Testing
- Secukinumab s.c. injection
- Where
- 171 sites in United States, Brazil and 18 more
- Volunteers
- 1,000 people
- Sponsor
- Novartis Pharmaceuticals
Thyroid Neoplasms, Carcinoma, Non-Small-Cell Lung
A Study of Selpercatinib (LY3527723) in Participants With Rearranged During Transfection (RET)-Altered Cancers in India
This study will evaluate the safety of selpercatinib in participants with RET-altered cancers in India. The study will also assess the number of changes and why participants stop study treatment.
- Trial name
- NCT07822880
- Testing
- Selpercatinib
- Where
- 10 sites in India
- Volunteers
- 30 people
- Sponsor
- Eli Lilly and Company
SARS-CoV-2
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment
- Trial name
- NCT07863635
- Testing
- mRNA-1273, mRNA-1283
- Where
- 5 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Duchenne Muscular Dystrophy
Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing Setting
The primary objective of this study is to evaluate acute liver injury (ALI) rates associated with ELEVIDYS with the addition of sirolimus as an adjunct prophylactic immunosuppression agent.
- Trial name
- ENHANCE (NCT07542314)
- Testing
- ELEVIDYS, Sirolimus, Glucocorticoids
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Sarepta Therapeutics, Inc.
Fascioliasis
Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).
The study evaluated safety and tolerability along with clinical outcomes of Egaten administered as per the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart) in Fascioliasis participants (≥ 6…
- Trial name
- NCT04230148
- Testing
- Egaten (Triclabendazole) 250 mg tablets
- Where
- 10 sites in Colombia, Egypt and 3 more
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
Ulcerative Colitis
Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of budesonide rectal foam as compared to an…
- Trial name
- NCT05976802
- Testing
- High dose budesonide rectal foam, Low dose budesonide rectal foam
- Volunteers
- 100 people
- Sponsor
- Bausch Health Americas, Inc.
Cataract
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
- Trial name
- NCT05191706
- Testing
- Dexamethasone, Prednisolone Acetate Ophthalmic
- Where
- 9 sites in United States
- Volunteers
- 17 people
- Sponsor
- EyePoint Pharmaceuticals, Inc.
Attention-Deficit/Hyperactivity Disorder
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.
- Trial name
- NCT04781140
- Testing
- 100mg SPN-812
- Where
- 54 sites in United States
- Volunteers
- 286 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Muscular Atrophy, Spinal
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered as an early intervention in pediatric participants with spinal muscular atrophy (SMA) and 2 SMN2…
- Trial name
- HINALEA 1 (NCT05861986)
- Testing
- Risdiplam
- Where
- 16 sites in United States, Germany and 2 more
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
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