Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE)

Completed · Phase 2

Conditions studied: Duchenne Muscular Dystrophy

In brief

This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up. The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002, each separated by three months.

Key facts

Study ID

NCT06304064

Run by

Capricor Inc.

People needed

8

Starts

2018-06-21

Expected to finish

2019-03-06

Last updated by the study team

2024-04-24

Who can join

Age: 12 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Documented enrollment in the Usual Care Treatment Group of the HOPE-Duchenne trial and completion of trial follow-up through Month 12.
• Willing and able to provide informed consent to participate in the trial if greater than or equal to (>=) 18 years of age, and assent with parental or guardian informed consent if less than (<) 18 years of age.
• Adequate venous access for intravenous CAP-1002 infusions and routine blood collections in the judgement of the Investigator.
• Assessed by the Investigator as willing and able to comply with the requirements of the trial.

You may not qualify if…

• Left ventricular ejection fraction (LVEF) < 35 percent (%) within 6 months of screening.
• Planned or likely major surgery in the next 6 months after planned first infusion.
• Risk of near-term respiratory decompensation in the judgment of the investigator, or the need for initiation of non-invasive ventilator support as defined by serum bicarbonate >= 29 millimoles per liter (mmol/L) at screening.
• History of non DMD-related chronic respiratory disease including, but not limited to, asthma, bronchitis, and tuberculosis.
• Acute respiratory illness within 30 days prior to screening.
• Known hypersensitivity to dimethyl sulfoxide (DMSO) or bovine products.
• Treatment with investigational product <= 6 months prior to first infusion.
• History, or current use, of drugs or alcohol that could impair ability to comply with participation in the trial.
• Inability to comply with the investigational plan and follow-up visit schedule for any reason, in the judgment of the investigator.

Where it is running

• University of Florida — Gainesville, Florida, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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