NCT06092606

A Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Monyan Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Purpose：1. Preliminary evaluation of the preventive effect of DH001 on doxorubicin-induced cardiotoxicity in cancer patients 2.To explore appropriate dosages to provide basis for dosages in subsequent confirmatory studies 3.To evaluate the effect of DH001 on the efficacy of doxorubicin treatment in cancer patients 4.To evaluate the safety of DH001 in cancer patients treated with doxorubicin

Detailed description

After the subjects sign the informed consent form, meet the inclusion criteria and do not meet the exclusion criteria, they will receive a random number according to the order of enrollment, and will be randomly assigned to the DH001 low-dose group (200 mg), DH001 high-dose group (400 mg) and control group in a 1:1:1 manner according to the randomization plan；Stratification factor: Patient's tumor type \[lymphoma and non-lymphoma (breast cancer, soft tissue sarcoma, etc.)\].

Conditions

• Cancer
• Heart Failure
• Arrhythmia
• Doxorubicin Induced Cardiomyopathy
• Doxorubicin Adverse Reaction

Interventions

Type	Name	Description
DRUG	Control group:DH001 placebo	Dosage: DH001 placebo (8 tablets)
DRUG	Trial group: DH001 low-dose group	Dosage: DH001 200mg (4 tablets) + DH001 placebo (4 tablets)
DRUG	Trial group: DH001 high-dose group	Dosage: DH001 400mg (8 tablets).

Timeline

• Start date: 2023-04-04
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: China