National CounterACT Initiative

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Mitochondrial Alteration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03597438

1R21NS103826-01 (U.S. NIH Grant/Contract)

18-015056

Details and patient eligibility

About

The purpose of the study is to determine in vitro effects on mitochondrial function of selected chemical agents in human cells, and assess the capability of a cell-permeable succinate prodrug to attenuate toxic effects The project aims at repurposing this recent pharmaceutical discovery, currently being developed for treatment of toxic exposure, for an expanded indication to treat chemically induced mitochondrial toxicity.

Full description

The study duration per subject will be approximately 15 minutes to complete the one time blood collection.

Enrollment: 236 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria:

1. Males or females age greater or equal 2 years of age
2. Weight greater or equal to 10 kg
3. Parental/guardian permission (informed consent) and if appropriate, child assent.

Patient Exclusion Criteria:

1. Known primary mitochondrial disorder.
2. Use of an investigational drug within 30 days prior to enrollment.
3. Parents/guardians or subjects who in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Volunteer Inclusion Criteria

1. Males or females > 18 years of age
2. Employee, trainee, or student informed consent

Volunteer Exclusion Criteria:

1. Prior enrollment in this study.
2. Known primary mitochondrial disorder.
3. Use of an investigational drug within 30 days prior to enrollment.

Trial design

236 participants in 2 patient groups

Patient

Description:

patients scheduled for elective surgery who are patients either as an inpatient or arriving to the hospital on the day of scheduled surgery

Volunteer

Description:

Volunteers who are employees, trainees and students at the Children's Hospital of Philadelphia (CHOP) will be introduced to the study via an informational study flyer to determine eligibility and desire to participate in the study