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

NCT05618691 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: GFH312X2201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intermittent Claudication; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• Absolute change from baseline in maximum walking distance (MWD) at Week 12 assessed by a 6-minute walking test (6-MWT)

  The 6-MWT will be performed according to the 2002 American Thoracic Society Guidelines

  12 weeks

• Incidence and severity of adverse events (AEs), SAEs

  Incidence and severity of adverse events (AEs), SAEs

  12 weeks

Secondary Outcomes (1)

• Pain-free walking distance (PFWD) at Week 12 assessed by a walking test

  12 weeks

Study Arms (4)

GFH312 40mg

EXPERIMENTAL

Participant will receive GFH312 40mg once daily approximately at same time each day for 12 weeks.

Drug: GFH312

GFH312 80mg

EXPERIMENTAL

Participant will receive GFH312 80mg once daily approximately at same time each day for 12 weeks.

Drug: GFH312

GFH312 120mg

EXPERIMENTAL

Participant will receive GFH312 120mg once daily approximately at same time each day for 12 weeks.

Drug: GFH312

Placebo

EXPERIMENTAL

Participant will receive placebo once daily approximately at same time each day for 12 weeks.

Other: Placebo

Interventions

GFH312 DRUG

Oral tablet, GFH312 will be administered at 3 dose levels, each patient in one of three groups will be given a dose of 40mg, 80mg, 120mg of the study drug.

GFH312 120mg; GFH312 40mg; GFH312 80mg

Placebo OTHER

Placebo will be administered to subjects in the placebo group

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-80 years.
• Patients diagnosed with PAD and IC for at least 6 months before screening and disease assessed as stage II per the Fontaine classification.
• 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.
• 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.

You may not qualify if:

• 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.
• Patients who meet any of the following PAD related criteria:
• 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.
• Patients unable to hold all narcotic pain relievers for 24 hours prior to the performance of the walking test.
• Patients with any condition other than PAD that limits walking ability (e.g., orthopaedic disease, respiratory disease, neurological disorders).
• Known inflammatory disease of the arteries (other than atherosclerosis, e.g., thromboangiitis obliterans).
• 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).
• 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).
• Any of the following concomitant cardiovascular or metabolic conditions or diseases:
• Myocardial infarction or angina pectoris within 6 months of screening.
• Stroke within 3 months of screening.
• History of clinically significant ventricular arrhythmias, according to the discretion of the investigator, within 6 months of screening.
• Patients with electronic cardiac pacemaker.
• Significant ECG abnormalities (e.g., WPW syndrome), according to the discretion of the investigator, at screening.
• History of sustained and clinically significant supraventricular arrhythmias (e.g., paroxysmal atrial fibrillation/flutter) within 6 months of screening.

Sponsors & Collaborators

• Zhejiang Genfleet Therapeutics Co., Ltd.: lead

Study Sites (1)

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52801, United States

Location

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a multicenter, double-blinded, randomized, placebo-controlled study, to evaluate the safety/tolerability and efficacy in three paralleled dose groups of GFH312 compared with placebo in patients with PAD and IC.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: November 16, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)