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

StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

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  1. Primary completion date: Mar 2022 to Nov 15, 2029
    • Start date: Mar 2020 to Sep 1, 2027
    • Study completion date: Mar 2023 to Jun 15, 2030
    v35
  2. Re-verified, no change to tracked fieldsv34
  3. Start date: Oct 15, 2019 to Mar 2020
    • Primary completion date: Oct 15, 2021 to Mar 2022
    • Study completion date: Oct 15, 2022 to Mar 2023
    v33
  4. 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
    v32
  5. Start date: Aug 30, 2019 to Oct 15, 2019v31 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 200 to 150
    • Primary completion date: Aug 30, 2021 to Oct 15, 2021
    • Study completion date: Aug 30, 2022 to Oct 15, 2022
    • 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…
    • Study arms: 4 to 2
Show 29 earlier versionsHide 29 earlier versions
  1. Enrollment target: 120 to 200v30 Show 4 more changesShow less
    • Study sites: 10 to 0
    • Primary completion date: Sep 30, 2021 to Aug 30, 2021
    • Study completion date: Sep 30, 2022 to Aug 30, 2022
    • Start date: Sep 30, 2019 to Aug 30, 2019
  2. Re-verified, no change to tracked fieldsv29
  3. Primary completion date: Jun 2015 to Sep 30, 2021v28 Show 4 more changesShow less
    • Start date: Sep 2008 to Sep 30, 2019
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Study completion date: Dec 2015 to Sep 30, 2022
    • Site contacts updated at 10 of 10 sites
  4. Re-verified, no change to tracked fieldsv27
  5. Primary completion date: Jun 2012 to Jun 2015
    • Study completion date: Dec 2012 to Dec 2015
    v26
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v25
  7. Primary completion date: Jun 2010 to Jun 2012
    • Study completion date: Dec 2010 to Dec 2012
    v24
  8. Primary completion date: Oct 2009 to Jun 2010
    • Study completion date: Dec 2009 to Dec 2010
    v23
  9. Study sites: 5 to 10
    • Eligibility criteria shortened, about 29 words
    v22
  10. Eligibility criteria expanded, about 202 wordsv21
  11. Study sites: 4 to 5v20
  12. Study title expanded, about 1 wordv19
  13. Eligibility criteria expanded, about 23 words
    • Site contacts updated at 1 of 4 sites
    v18
  14. Study sites: 1 to 4v17
  15. 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
    v16
  16. Start date: Jun 2008 to Aug 2008
    • Primary completion date: Jul 2009 to Aug 2009
    • Study completion date: Jul 2009 to Dec 2009
    v15
  17. Primary completion date: Jun 2009 to Jul 2009
    • Study completion date: Jun 2010 to Jul 2009
    • Start date: May 2008 to Jun 2008
    v14
  18. Re-verified, no change to tracked fieldsv13
  19. Primary completion date: Apr 2009 to Jun 2009
    • Study completion date: Jun 2010
    • Start date: Apr 2008 to May 2008
    v12
  20. Eligibility criteria expanded, about 558 words
    • Study title expanded, about 3 words
    v11
  21. Primary completion date: Mar 2009 to Apr 2009
    • Start date: Mar 2008 to Apr 2008
    v10
  22. 2 versions Re-verified since Jan 25, 2008, no change to tracked fieldsv8-v9
  23. 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
    v7
  24. Study title shortened, about 3 wordsv6
  25. Phase: Phase 1 to Phase 2v5 Show 7 more changesShow less
    • Enrollment target: 20 to 120
    • Start date: Jun 2004 to Sep 2007
    • Trial status: Completed to Not Yet Recruiting
    • Study sites: 6 to 0
    • Eligibility criteria expanded, about 300 words
    • Collaborators shortened, about 3 words
    • Study title expanded, about 2 words
  26. Re-verified, no change to tracked fieldsv4
  27. Trial status: Recruiting to Completed
    • Site details revised at 6 of 6 sites
    v3
  28. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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
(from sponsor)		 Coronary Disease, Coronary Heart Disease, Myocardial Ischemia, Coronary Arteriosclerosis
Related terms Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov