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Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Primary completion date: Mar 2022 to Nov 15, 2029

    Start date: Mar 2020 to Sep 1, 2027; Completion date: Mar 2023 to Jun 15, 2030

    Study Status, Contacts/Locations, Referencesv35

  2. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v34

  3. Notable

    Start date: Oct 15, 2019 to Mar 2020

    Primary completion date: Oct 15, 2021 to Mar 2022; Completion date: Oct 15, 2022 to Mar 2023

    Study Statusv33

  4. Minor

    Interventions: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose (Combination Product), Human Recombinant Fibroblast Growth Factor-1… to Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose (Combination Product), Human Recombinant Fibroblast Growth Factor-1…

    Secondary endpoints: details revised at 1 of 1 entry; Study arms: 2 to 3

    Study Status, Arms and Interventions, Outcome Measures, Contacts/Locationsv32

  5. Notable

    Start date: Aug 30, 2019 to Oct 15, 2019

    Primary endpoints: 1 to 2; Enrollment target: 200 to 150; Primary completion date: Aug 30, 2021 to Oct 15, 2021; and 3 more

    Show all 7 changes in this update
    • Notable Start date: Aug 30, 2019 to Oct 15, 2019
    • Notable Primary endpoints: 1 to 2
      Show what changed
      Change in CCS angina score Change in cardiac perfusion as measured by SPECTcMRI scan under stress conditions and change in vascular bed density at the sites of injections as determined by angiography
    • Minor Enrollment target: 200 to 150
    • Minor Primary completion date: Aug 30, 2021 to Oct 15, 2021
    • Minor Completion date: Aug 30, 2022 to Oct 15, 2022
    • Minor Interventions: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) (Drug), Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) (Drug), Human… to Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose (Combination Product), Human Recombinant Fibroblast Growth Factor-1…
    • Minor Study arms: 4 to 2

    Study Status, Oversight, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locationsv31

Show 29 earlier versions

  1. Notable

    Enrollment target: 120 to 200

    Study sites: 10 to 0; Primary completion date: Sep 30, 2021 to Aug 30, 2021; Completion date: Sep 30, 2022 to Aug 30, 2022; and 1 more

    Show all 5 changes in this update
    • Notable Enrollment target: 120 to 200
    • Minor Study sites: 10 to 0
    • Minor Primary completion date: Sep 30, 2021 to Aug 30, 2021
    • Minor Completion date: Sep 30, 2022 to Aug 30, 2022
    • Minor Start date: Sep 30, 2019 to Aug 30, 2019

    Study Identification, Study Status, Study Description, Study Design, Contacts/Locationsv30

  2. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v29

  3. Notable

    Primary completion date: Jun 2015 to Sep 30, 2021

    Start date: Sep 2008 to Sep 30, 2019; Trial status: Active, Not Recruiting to Not Yet Recruiting; Completion date: Dec 2015 to Sep 30, 2022; and 1 more

    Show all 5 changes in this update
    • Notable Primary completion date: Jun 2015 to Sep 30, 2021
    • Notable Start date: Sep 2008 to Sep 30, 2019
    • Minor Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Minor Completion date: Dec 2015 to Sep 30, 2022
    • Minor Site contacts updated at 10 of 10 sites

    Study Status, Oversight, Contacts/Locationsv28

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v27

  5. Notable

    Primary completion date: Jun 2012 to Jun 2015

    Completion date: Dec 2012 to Dec 2015

    Study Statusv26

  6. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised at 10 of 10 sites

    Study Status, Sponsor/Collaborators, Contacts/Locationsv25

  7. Notable

    Primary completion date: Jun 2010 to Jun 2012

    Completion date: Dec 2010 to Dec 2012

    Study Statusv24

  8. Notable

    Primary completion date: Oct 2009 to Jun 2010

    Completion date: Dec 2009 to Dec 2010

    Study Statusv23

  9. Minor

    Study sites: 5 to 10

    Eligibility criteria shortened, about 29 words

    Show what changed: Eligibility criteria
    Inclusion criteria Sign an informed consent form prior to the initiation of any study procedures. Subjects must be competent to give written informed consent. Age ≥25 and ≤75 years and may be of, either gender, and any race. At least a 3 month history of chronic, stable angina that is documented as triggered by physical effort, and is relieved by rest and/or nitroglycerin. Documented sym [...]

    Study Status, Eligibility, Contacts/Locationsv22

  10. Minor

    Eligibility criteria expanded, about 202 words

    Show what changed: Eligibility criteria
    Inclusion Criteria:criteria Must signSign an informed consent form prior to the initiation of any study procedures. Subjects must be competent to give written informed consent. Age ≥25 and ≤75 years and may be of either gender and any [...] ed by rest and/or nitroglycerin. Documented symptomatic CCS AnginalAngina Classification of III to IV despite use of optimal medical therapy as noted in inclusionInclusion criterionCriterion 1110. Pattern of CHD (coronary pathology) where percutaneous int [...] nd/or CABG is not recommended by the treating cardiologist. This decision should have a documented basis in ei [...] [...]

    Study Status, Eligibilityv21

  11. Minor

    Study sites: 4 to 5

    Study Status, Contacts/Locationsv20

  12. Minor

    Study title expanded, about 1 word

    Show what changed: Study title
    Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease

    Study Identification, Study Status, Contacts/Locationsv19

  13. Minor

    Eligibility criteria expanded, about 23 words

    Site contacts updated at 1 of 4 sites

    Show what changed: Eligibility criteria
    [...] llowing medications: beta-blockers, calcium entry blockers, ranolizineranolazine, or long-acting nitrates. Exercise duration during the qual [...] vidence of concurrent clinically significant infection (e.g., elevated white blood cell [WBC] count > 13,000 x 109/L, temp [...]

    Study Status, Eligibility, Contacts/Locationsv18

  14. Minor

    Study sites: 1 to 4

    Study Status, Contacts/Locationsv17

  15. Notable

    Trial status: Not Yet Recruiting to Recruiting

    Study sites: 0 to 1; Primary completion date: Aug 2009 to Oct 2009; Start date: Aug 2008 to Sep 2008

    Study Identification, Study Status, Contacts/Locationsv16

  16. Notable

    Start date: Jun 2008 to Aug 2008

    Primary completion date: Jul 2009 to Aug 2009; Completion date: Jul 2009 to Dec 2009

    Study Statusv15

  17. Minor

    Primary completion date: Jun 2009 to Jul 2009

    Completion date: Jun 2010 to Jul 2009; Start date: May 2008 to Jun 2008

    Study Statusv14

  18. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v13

  19. Minor

    Primary completion date: Apr 2009 to Jun 2009

    Completion date: Jun 2010; Start date: Apr 2008 to May 2008

    Study Statusv12

  20. Minor

    Eligibility criteria expanded, about 558 words

    Study title expanded, about 3 words

    Show what changed: Eligibility criteria
    [...] ility to complete the study in compliance with the protocol. Exclusion Criteria History of undergoing a CABG, PTCA or TMR or evidence of an acute MI in the last 3 months. Subjects with malignancies or a history of malignancies (with the exception of basal cell carcinoma [BCC] of the skin) will be excluded from the study. Those subjects with a history of BCC [...]
    Show what changed: Study title
    Fibroblast Growth Factor-1 (FGF-1) for Treatment of Coronary Heart Disease

    Study Identification, Study Status, Eligibilityv11

  21. Minor

    Primary completion date: Mar 2009 to Apr 2009

    Start date: Mar 2008 to Apr 2008

    Study Statusv10

  22. Minor

    2 amendments

    2 re-verifications since 2008-01-25, no change to tracked fields

    v8-v9

  23. Notable

    Start date: Sep 2007 to Mar 2008

    Primary completion date: Mar 2009; Interventions: Human Fibroblast Growth Factor 1 (Drug) to Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) (Drug), Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) (Drug), Human…; Study arms: 0 to 4

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Conditions, Study Design, Arms and Interventionsv7

  24. Minor

    Study title shortened, about 3 words

    Show what changed: Study title
    Recombinant Human Growth FactorFGF-1 for Treatment of Coronary Heart Disease

    Study Identification, Study Statusv6

  25. Notable

    Phase: Phase 1 to Phase 2

    Enrollment target: 20 to 120; Start date: Jun 2004 to Sep 2007; Trial status: Completed to Not Yet Recruiting; and 4 more

    Show all 8 changes in this update
    • Notable Phase: Phase 1 to Phase 2
    • Notable Enrollment target: 20 to 120
    • Notable Start date: Jun 2004 to Sep 2007
    • Minor Trial status: Completed to Not Yet Recruiting
    • Minor Study sites: 6 to 0
    • Minor Eligibility criteria expanded, about 300 words
      Show what changed
      Inclusion Criteria: Must sign an informed consent form. Age ≥25 and ≤75 years and may be of either gender and any race. At least a 3 month history of chronic, stable angina Mini-thoracotomy that is documented as triggered by physical effort, and anesthesiais relieved by rest and/or nitroglycerin. Documented symptomatic CCS Anginal Classification of III to IV despite use of optimal medical therapy as noted in inclusion criterion 11. Pattern of CHD (coronary pathology) where percutaneous interventional therapy and/or CABG is not contraindicated Notrecommended eligibleby forthe bypasstreating or [...] [...]
    • Minor Collaborators shortened, about 3 words
      Show what changed
      Cardiovascular Clinical Research
    • Minor Study title expanded, about 2 words
      Show what changed
      CardioRecombinant VascuHuman Growth Factor-Grow1 for Treatment of Coronary Heart Disease

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations, Referencesv5

  26. Minor

    Study Status

    Re-verified, no change to tracked fields

    v4

  27. Minor

    Trial status: Recruiting to Completed

    Site details revised at 6 of 6 sites

    Study Status, Contacts/Locationsv3

  28. Minor

    Study Status

    Re-verified, no change to tracked fields

    v2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Treatment for no-option heart patients with coronary artery disease. Procedure includes the injection into the heart of a protein growth factor, administered by the Biological Delivery Systems MyoStar injection and mapping catheters, to stimulate the growth of blood vessels around blocked coronary arteries.
Trial Details
NCT Number NCT00117936
Lead Sponsor Venturis Therapeutics, Inc.
Conditions Coronary Disease, Coronary Heart Disease, Myocardial Ischemia, Coronary Arteriosclerosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov