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

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

Conditions

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

Interventions

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).

Sponsors & Collaborators

• Monyan Pharmaceutical (Shanghai) Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Jun Zhu · Peking University Cancer Hospital & Institute

• Hongmei Jing · Peking University Third Hospital

• Hui Zhou · Hunan Cancer Hospital

• Yufu Li · Henan Cancer Hospital

• Hesheng He · The First Affilaited Hospital of Wannan Medical College

• Zeping Zhou · The Second Affiliated Hospital of Kunming Medical University

• Wenbin Qian · Second Affiliated Hospital, School of Medicine, Zhejiang University

• Xiaojia Wang · Zhejiang Cancer Hospital

• Jiwei Liu · The First Affiliated Hospital of Dalian Medical University

• Zhenchang Sun · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-04

Primary Completion

2025-01-31

Completion

2025-01-31

Countries

• China

Study Locations