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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06092606
Other study ID # CTR20232122
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 4, 2023
Est. completion date January 31, 2025

Study information

Verified date October 2023
Source Monyan Pharmaceutical (Shanghai) Co., Ltd.
Contact Jun Ma
Phone +86 133 0451 8000
Email majun0322@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.)].


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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Harbin Institute of Hematology and Cancer Harbin Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
Monyan Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of cardiac events The incidence of cardiac events in subjects during doxorubicin treatment 18-24 weeks
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