NCT07475754

A Study to Evaluate the Safety and Tolerability of Rituxan in Duchenne Muscular Dystrophy

Not yet recruiting NA Last updated 16 March 2026

What this trial tests

NA trial testing Rituxan treatment in Duchenne Muscular Dystrophy (DMD) in 5 participants. Not yet recruiting.

Timeline

23 March 2026

Primary endpoint
30 May 2026

23 April 2027

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	23 March 2026
Primary completion	30 May 2026
Estimated completion	23 April 2027

Drugs / interventions tested

• Rituxan treatment — full drug profile →

Conditions studied

• Duchenne Muscular Dystrophy (DMD) — all drugs for Duchenne Muscular Dystrophy (DMD) →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 6 to 10, female only, with Duchenne Muscular Dystrophy (DMD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. Study population:It is applicable to male participants with genetically confirmed and clinically confirmed Duchenne muscular dystrophy (DMD), aged between 6 and 10 years.
2. Research period:The main research period of this clinical study is one year. Participants were tested during the baseline period and were followed up on days 0, 7, 14, 21, 60, 120, 200, and 360.
3. Exploratory indicators：MR Of both thighs, quantitatively calculating the muscle fat replacement indicators of the buttocks and proximal thighs；Patient Self-Rating Scale, Caregiver Self-Rating Scale.
4. Safety assessment：The safety assessment population will include all participants who have received the drug dose and have at least one post-drug safety assessment. Adverse events (AE) collected from the participants signed informed consent, all the way to the main study period at the end of the last follow-up. Safety laboratory evaluation, laboratory safety monitoring, including hematology, blood biochemistry, urine analysis (including troponin I, CK and CK - MB) and blood coagulation function, as well as complement. All common medication will be recorded. All adverse events, including abnormal complete blood cell count results, will be continuously tracked until they are resolved or stabilized. Only treatment-related adverse events (TEAE) will be summarized. AEs will be based on MedDRA and organ systems are recorded and archived. The classification and terminology related to AEs will be described according to the version of CTCAE v6.0.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.