NCT06558253

The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A single-center, open-label, dose-escalation study 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.

Conditions

• Hematopoietic Recovery

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-11-29
• Primary completion: 2026-04-01
• Completion: 2026-09-30
• First posted: 2024-08-16
• Last updated: 2024-12-18

Locations

1 site across 1 country: China