Intermittent ClaudicationPhase 2NCT05618691
A Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)
A Phase 2 study testing GFH312 in people with Intermittent Claudication and Peripheral Artery Disease, run by Zhejiang Genfleet Therapeutics Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Intermittent Claudication, Peripheral Artery Disease
- What is being tested?
- GFH312
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 31 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 31Show fewer
- 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.
- Chronic heart failure New York Heart Association Class III or IV.
- Known presence of aortic aneurysm > 5 cm.
- Uncontrolled diabetes as defined by a random fasting glucose level of 13 mmol/L or 240 mg/dL or a HbA1c greater than 9% as measured at screening.
- Uncontrolled or resistant hypertension, defined as BP>160/100 mm Hg after standard anti-hypertension treatment.
- History of unstable or severe hepatic or renal disease or another medically significant illness
- History of any of the following chronic conditions:
- Malignancy of any organ system (other than localized basal or squamous cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result, and severe uncontrolled ulcerative colitis or Crohn's disease.
- History of any hypercoagulable or bleeding disorders.
- History of significant and active drug or alcohol abuse that could interfere with conduct of the trial within the 12 months prior to dosing. Note: investigator may establish veracity of patient history with drug or alcohol testing as deemed necessary.
- Dementia or other mental disorders (e.g., continues to receive medication or psychological intervention) that prevent patients from following a research protocol.
- Major surgical procedure before screening or planned to occur during the planned time frame of the study.
- History of multiple and clinically significant recurring drug allergies.
- Use of strong inhibitors or strong inducers of CYP3A4 within 14 days or 5 half-lives (whichever longer); or grapefruit juice or grapefruit containing products within 7 days prior to first study treatment.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test.
- Any medical condition (e.g., with a plan to receive vaccination within study duration) that in the opinion of the investigator may place the patient at higher risk from his/her participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52801
About this study
Official title: A Double-blinded, Randomized, Placebo-controlled Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)
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.
- Being tested
- GFH312, Placebo
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH312Drug
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.
PlaceboOther
Placebo will be administered to subjects in the placebo group
| Study group | Role | What they receive |
|---|---|---|
| GFH312 40mg | Experimental | Participant will receive GFH312 40mg once daily approximately at same time each day for 12 weeks. Receives: Drug: GFH312 |
| GFH312 80mg | Experimental | Participant will receive GFH312 80mg once daily approximately at same time each day for 12 weeks. Receives: Drug: GFH312 |
| GFH312 120mg | Experimental | Participant will receive GFH312 120mg once daily approximately at same time each day for 12 weeks. Receives: Drug: GFH312 |
| Placebo | Experimental | Participant will receive placebo once daily approximately at same time each day for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Incidence and severity of adverse events (AEs), SAEs
Incidence and severity of adverse events (AEs), SAEs
Measured: 12 weeks
Secondary outcomes (1)
Pain-free walking distance (PFWD) at Week 12 assessed by a walking test
Pain-free walking distance would be collected during the test of 6-MWT, the 6-MWT will be performed according to the 2002 American Thoracic Society Guidelines
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 May 2024 (estimated)
Why it stopped: The study was terminated by sponsor for reasons of adjusted clinical development strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618691
- Sponsor's protocol ID
- GFH312X2201
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized, Placebo-controlled Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)
- ClinicalTrials.gov ID
- NCT05618691
- Acronym / sponsor ID
- GFH312X2201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated by sponsor for reasons of adjusted clinical development strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GFH312 40mg | Experimental | Drug: GFH312Participant will receive GFH312 40mg once daily approximately at same time each day for 12 weeks. |
| GFH312 80mg | Experimental | Drug: GFH312Participant will receive GFH312 80mg once daily approximately at same time each day for 12 weeks. |
| GFH312 120mg | Experimental | Drug: GFH312Participant will receive GFH312 120mg once daily approximately at same time each day for 12 weeks. |
| Placebo | Experimental | Other: PlaceboParticipant will receive placebo once daily approximately at same time each day for 12 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (31 listed)
- 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:
- Any of the following concomitant cardiovascular or metabolic conditions or diseases:
- History of unstable or severe hepatic or renal disease or another medically significant illness
- History of any of the following chronic conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFH312Oral 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. | Drug | GFH312 120mg, GFH312 40mg, GFH312 80mg |
| PlaceboPlacebo will be administered to subjects in the placebo group | Other | Placebo |
Primary outcome
Absolute change from baseline in maximum walking distance (MWD) at Week 12 assessed by a 6-minute walking test (6-MWT)
Time frame: 12 weeks
The 6-MWT will be performed according to the 2002 American Thoracic Society Guidelines
Incidence and severity of adverse events (AEs), SAEs
Time frame: 12 weeks
Incidence and severity of adverse events (AEs), SAEs
1 secondary outcome
Pain-free walking distance (PFWD) at Week 12 assessed by a walking test
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GFH312 in people with Intermittent Claudication and Peripheral Artery Disease, run by Zhejiang Genfleet Therapeutics Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline in maximum walking distance (MWD) at Week 12 assessed by a 6-minute walking test (6-MWT) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.