A Phase 2 interventional study of Etribnabdione 25 mg BID and Etribnabdione 50 mg BID in Peripheral Arterial Disease, sponsored by VivaCell Biotechnology España. Not yet recruiting at 1 site in Spain. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by VivaCell Biotechnology España · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to study the safety and tolerability of Etrinabdione in adult patients with peripheral arterial disease. It will also learn about the preliminary efficacy of Etrinabdione. The main questions it aims to answer are:
Has Etrinabdione an acceptable safety/tolerability profile during 12 months?
Do the patients show any improvement in any of the tests included in the protocol for this disease?
Researchers will test first the low dose of Etrinadione. If the product is safe at 3 months, the high dose can start.
Participants will:
Take Etrinabdione twice a day for 12 months. Visit the clinic once every 4 weeks for checkups and tests.
This is a single center, open-label Phase IIa clinical study. The study will be conducted with 2 treatment arms 25 mg BID and 50 mg BID.
The study consists of a Screening Period, a Treatment Period, and a Follow-up Period. Total duration 14 months.
Subjects who meet the inclusion criteria and do not meet the exclusion criteria at screening will start with the lower dose (25 mg BID). When the 12 patients have been treated for 3 months and the PK and safety data are evaluated by the regulatory authority, the Sponsor and the site investigators, the high dose (50 mg BID) will be released.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →This is the only study on the registry with VivaCell Biotechnology España as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
25 mg BID
Drug: Etribnabdione 25 mg BID
50 mg BID
Drug: Etribnabdione 50 mg BID
The trial will start with the lower dose. When the 12 patients have been treated for 3 months and the PK and safety data are evaluated by the regulatory authority, the Sponsor and the site investigators, the high dose (50 mg BID) will be released.
The treatment will start when the regulatory authority, the sponsor and the site investigators have reviewed the low dose safety and pharmacokinetics data.
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Time frame: 13 months
Vascularization
The angiogenesis induced by Etrinabdione treatment will be assessed by the evaluation of the peripheral arterial system of affected limbs by computed tomography angiography.
Time frame: Baseline, 6 and 12 months
Absolute claudication time
The claudication time will be quantitatively measured by standardized treadmill test using a graded exercise protocol.
Time frame: Baseline, 3, 6 and 12 months
Hemodynamic
The Ankle/Brachial Index (ABI) is a diagnostic measure used to assess blood flow and detect potential vascular abnormalities. It will be calculated as the ratio of systolic blood pressure at the ankle level (posterior tibial artery or pedia) divided by the systolic blood pressure obtained on the arm (humeral artery).
Time frame: Baseline, 3, 6 and 12 months
Stenosis
Doppler ultrasound will be performed in the affected lower limbs at the level of the common femoral artery, superficial femoral artery, popliteal artery, posterior tibial artery and pedia artery.
Time frame: Baseline, 3, 6 and 12 months
Disease specific quality of life questionnaire (VascuQoL-6)
The questionnaire includes 6 questions with 4 possible answers, scoring from 1 to 4. The lower the score, the worse the patient's perceived quality of life.
Time frame: Baseline, 3, 6 and 12 months
Tissue oxigenation
Measure the local oxygen released from the capillaries through the skin by transcutaneous oximetry.
Time frame: Baseline, 3, 6 and 12 months
Pharmacokinetic profile of Etrinabdione in terms of maximum observed plasma concentration (Cmax).
The point of maximum concentration of Etrinabdione in plasma.
Time frame: pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6, 12, and 13 months.
Pharmacokinetic profile of Etrinabdione in terms of time to peak drug concentration (Tmax).
The time of Etrinabdine to reach its maximum concentration in the body after administration
Time frame: pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6, 12, and 13 months.
Pharmacokinetic profile of Etrinabdione in terms of area under the plasma concentration-time curve (AUC).
Total systemic exposure to Etrinabdione.
Time frame: pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6, 12, and 13 months.
Determination of potential accumulation of Etrinabdione.
Etrinabdione plasma through level.
Time frame: pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6, 12, and 13 months.
Change in blood levels of disease/mechanism of action biomarkers measured by proximity extension assay and next-generation sequencing. All levels of plasma proteins will be provided in normalized protein expression units (NPX).
von Willebrand factor, Angiogenin, EPO, HGF, VEGF, FGF-2, PDGF, Endoglin, Endothelin-1, IL-1, TNFa, IL-6, IL-17, ICAM-1, IL-18, Proteinase-activated receptor 1, Angiopoietin-1, Endothelial cell-specific molecule 1, IL-18 and MCP1
Time frame: Day 1 and months 1, 3, 6, 12, and 13 months.
Start is estimated for Jan 2026; primary completion for Mar 2027, 14 months later.
Of 27 phase 2 interventional studies under Peripheral Arterial Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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