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A Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC) | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

A Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)

A Double-blinded, Randomized, Placebo-controlled Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)

NCT05618691•Zhejiang Genfleet Therapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

GFH312 could be a novel therapeutic option in the acute/chronic inflammatory process of atherosclerosis and provides potential beneficial effects to microvasculature function for PAD patients with IC in addition to preventing ischemia-reperfusion injury. This phase II study is designed to explore the clinical safety and efficacy of GFH312 after multiple oral doses, to support further development in patients with PAD or other atherosclerotic diseases.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 40-80 years.
•2. Patients diagnosed with PAD and IC for at least 6 months before screening and disease assessed as stage II per the Fontaine classification.
•3. Patients on stable medical therapy for PAD and IC symptoms, which may include lifestyle modification (e.g., smoking cessation), a community- or home-based exercise rehabilitation program, anti-platelet medications, and individual risk factor intervention (e.g., lipid-lowering therapy, antihypertensive therapy, glycemic control) unless individually contraindicated, for at least 3 months prior to the screening visit.
•4. For patients with reproductive potential, a willingness to use methods of contraception that will prevent the patients or their partners from becoming pregnant during the study.

Exclusion Criteria

•1. Participation in any clinical investigation within 4 weeks prior to enrollment or use of other investigational drugs at the time of enrollment, or within 5 half-lives at the time of enrollment, or until the expected PD effect has returned to baseline, whichever longer.
•2. Patients who meet any of the following PAD related criteria:
•1. Patients with high variability in the walking distance, defined as the change ≥25% in MWD between two 6-MWT with a time interval of two to three weeks.
•2. Patients unable to hold all narcotic pain relievers for 24 hours prior to the performance of the walking test.
•3. Patients with any condition other than PAD that limits walking ability (e.g., orthopaedic disease, respiratory disease, neurological disorders).
•4. Known inflammatory disease of the arteries (other than atherosclerosis, e.g., thromboangiitis obliterans).
•5. Clinical evidence of critical limb ischemia including new or non-healing ulcers (felt secondary to critical limb ischemia), new or recent onset of resting pain in the lower extremities particularly at night (felt secondary to critical limb ischemia) and/or gangrene of the lower extremities (Fontaine stage III-IV).
•6. Patients actively attending and participating in a supervised exercise rehabilitation program (patients who have already completed such a program and remain symptomatic may be included).
•3. Any of the following concomitant cardiovascular or metabolic conditions or diseases:
•1. Myocardial infarction or angina pectoris within 6 months of screening.
+21 more criteria

Locations (1)

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Key Dates

Start Date

December 1, 2022

Primary Completion Date

December 31, 2023

Completion Date

May 31, 2024

Last Updated

September 6, 2023

Conditions

Intermittent ClaudicationPeripheral Artery Disease

Interventions

GFH312

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)

Inclusion Criteria

Exclusion Criteria

Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Vascular Lab Resource (VLR) Biorepository

Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease

The COCOA-PAD II Trial

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease