In short
Clinical trials investigating Hydrocortisone Sodium Phosphate are studying how it is used in different patient groups and conditions, including acute lymphoblastic leukaemia and eye diseases. These trials look at safety, efficacy, and key outcomes such as survival, symptom relief, and eye pressure. Some studies also include children, young adults, and patients with specific eye or cancer-related needs.
Key points
- Clinical trials investigating Hydrocortisone Sodium Phosphate are studying different patient groups, including people with acute lymphoblastic leukaemia and several eye conditions. The trial data show Phase 3, Phase 4, and low-intervention studies. Researchers are measuring outcomes such as survival, symptom scores, inflammatory markers, and eye pressure. Some studies include children and young adults, while others focus on adults with eye symptoms or patients with ocular prostheses. The trials use different treatment plans and comparison groups, depending on the condition being studied.
Trial overview
The trial data show that Hydrocortisone Sodium Phosphate is being studied in different clinical settings, not just one disease area. In the available studies, it appears in research on acute lymphoblastic leukaemia, eye conditions, and inflammatory eye secretions. The studies are designed to learn about benefit, safety, and how patients respond over time.
Who participates in these studies
The target groups are different across trials. One large protocol includes infants, children, and young adults with acute lymphoblastic leukaemia, with an enrollment of 8,503 participants. Eye trials include adults with dry eye disease and moderate meibomian gland dysfunction, and patients with ocular prostheses who have inflammatory conjunctival secretions. Another trial includes people with recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa.
Conditions studied
The main condition in the largest study is acute lymphoblastic leukaemia, a cancer of the blood and bone marrow. In the eye studies, the conditions are dry eye disease with moderate meibomian gland dysfunction and inflammatory secretions of the conjunctiva in patients with ocular prostheses. The data also include trials in recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa, which are serious skin conditions.
Phases and study designs
The studies include Phase 3, Phase 4, and one low-intervention trial. Phase 3 trials often compare treatments in larger groups to see how well they work and how safe they are. Phase 4 research usually happens later and can help learn more about treatment results in broader use. The low-intervention study uses a simpler comparison design in a small group of 30 participants.
Some studies compare Hydrocortisone Sodium Phosphate with other treatments or with a control group. For example, one eye study compares topical hydrocortisone with dexamethasone and a tear substitute. The leukemia protocol includes several treatment paths and compares outcomes with control populations or historical controls.
Main outcomes and endpoints
The trials measure different endpoints, depending on the disease being studied. In the leukemia protocol, the main outcomes include event-free survival, disease-free survival, and the fraction of patients with undetectable MRD after one cycle of blinatumomab in a specific subgroup. These are important because they show whether treatment helps patients stay free from relapse or other bad events.
In the eye studies, researchers measure symptom scores, inflammatory markers in tears, and eye safety outcomes such as intraocular pressure. One trial uses the Secretion Self-Rating Scale score to track how patients rate their conjunctival secretions. Another trial looks at change in dry eye and meibomian gland dysfunction symptom scores from day 0 to day 14, as well as changes in tear cytokines and eye pressure over time.
In the epidermolysis bullosa study, the main endpoint is the proportion of subjects with complete target wound closure at Month 6, confirmed 2 weeks later. This endpoint checks whether the wound is fully closed and stays closed for a short follow-up period.
Trial-by-trial details
- NCT04307576 is a large Phase 4 protocol for participants 0-45 years old with acute lymphoblastic leukaemia. It is authorised and has an enrollment of 8,503 participants. Hydrocortisone Sodium Phosphate is given intrathecally, which means into the spinal fluid space.
- NCT05668455 is a low-intervention study in adults with inflammatory secretions of the conjunctiva and ocular prostheses. It compares topical hydrocortisone with dexamethasone and a tear substitute, and measures a secretion rating score. The study is authorised and includes 30 participants.
- 2024-518093-13-00 is a completed Phase 3 study in dry eye disease with moderate meibomian gland dysfunction. It includes 54 participants and measures symptom change, tear cytokines, and increased intraocular pressure. The trial uses topical Softacort as the Hydrocortisone Sodium Phosphate-related treatment in the eye.
- NCT05464381 is a Phase 3 authorised trial in recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa. It includes 167 participants and studies intravenous allo-APZ2-OTS versus placebo, with an additional open-label arm for some patients. The main outcome is complete target wound closure at Month 6.