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The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
Sponsor: Anhui Provincial Hospital
Summary
To assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.
Official title: An Exploratory Study to Assess the Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery After Single-unit Unrelated Cord Blood Transplantation in Patients With Hematological Malignancies
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2024-11-29
Completion Date
2026-09-30
Last Updated
2024-12-18
Healthy Volunteers
No
Conditions
Interventions
Coenzyme I for Injection
Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection, starting from the day of transplantation , and then continuously applied intravenously until 20 days post transplantation, with three dose groups: subjects #1-3 received one intravenous infusion per day containing 10 mg of Coenzyme I for injection, subjects #4-6 received one intravenous infusion per day containing 20 mg of Coenzyme I for injection, and subjects #7-12 received one intravenous infusion per day containing 50 mg of Coenzyme I for injection. Subjects in either dose group experienced a treatment-related Grade 3 or higher adverse reaction, the previous dose group was the maximum tolerated dose.
Locations (1)
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China