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RECRUITING
NCT05956418
PHASE4

A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients

Sponsor: Pharmazz, Inc.

View on ClinicalTrials.gov

Summary

This is a prospective, multi-centric, open-labeled, phase-IV clinical study to evaluate the safety and efficacy of centhaquine citrate (LYFAQUIN™), a first-in-class drug for treating hypovolemic shock, a life-threatening condition caused by severe blood or fluid loss. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. It has demonstrated the ability to decrease blood lactate levels, increase mean arterial pressure, enhance cardiac output, and reduce mortality rates. The increase in cardiac output during resuscitation is primarily attributed to an augmentation in stroke volume. Centhaquine exerts its effects by acting on the venous α2B-adrenergic receptors, which enhances venous return to the heart. Additionally, it produces arterial dilation by targeting central α2A-adrenergic receptors, thereby reducing sympathetic activity and systemic vascular resistance.

Official title: A Prospective, Multi-centric, Open-labeled, Phase-IV Study to Assess Safety and Efficacy of LYFAQUIN™ (Centhaquine Citrate) as a Resuscitative Agent for Hypovolemic Shock to be Used as an Adjuvant to Standard Treatment of Shock

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2021-08-13

Completion Date

2026-08

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DRUG

Centhaquine

Centhaquine (LYFAQUIN™ or centhaquine citrate) is a novel, first-in-class, highly effective resuscitative agent for hypovolemic shock. Phase II results demonstrate highly significant efficacy in improving blood pressure (p\<0.0001), lactate levels (p=0.0012) and base-deficit (p\<0.0001). There was also improvement in reduction in use of vasopressors and reduced mortality. Similarly, results of phase III study confirmed the safety and efficacy of centhaquine as an adjuvant to standard of care for hypovolemic shock. Therefore, to assess safety of centhaquine in large population a phase IV study (post-authorization safety study) has been designed.

Locations (17)

ACSR Government Medical College and Hospital

Nellore, Andhra Pradesh, India

All India Institute of Medical Sciences (AIIMS)

Raipur, Chhattisgarh, India

Aman Hospital

Vadodara, Gujarat, India

New Era Hospital

Nagpur, Maharashtra, India

Seven Star Hospital

Nagpur, Maharashtra, India

Meditrina Hospital

Nagpur, Maharashtra, India

Sri Guru Ram Das University of Health Sciences (SGRDH)

Amritsar, Punjab, India

Dayanand Medical College & Hospital (DMCH)

Ludhiana, Punjab, India

Christian Medical College and Hospital (CMC)

Ludhiana, Punjab, India

Government Medical College

Kota, Rajasthan, India

KG Hospital

Coimbatore, Tamil Nadu, India

Pushpanjali Hospital

Agra, Uttar Pradesh, India

Maharani Laxmi Bai Medical College (MLBMC)

Jhānsi, Uttar Pradesh, India

Nirmal Hospital

Jhānsi, Uttar Pradesh, India

Ganesh Shankar Vidyarthi Memorial Medical College (GSVM)

Kanpur, Uttar Pradesh, India

Janta Hospital

Varanasi, Uttar Pradesh, India

IPGMER & SSKM Hospital

Kolkata, West Bengal, India