RE:RE:RE:8% & 99% efficacy...LaserStock29 wrote: CLinical Trial Gov Estimated Enrollment:9
Actual Study Start Date:December 21, 2016
Estimated Study Completion Date:December 1, 2017
Estimated Primary Completion Date:December 1, 2017 (
Final data collection date for primary outcome measure) Primary Outcome Measures: - Assessment of Safety: Evaluation of the safety of TLD1433 will be assessed with the incidence and severity of Adverse Effects [ Time Frame: Up to the completion of follow-up phase (180 days) ]
Hematology, blood chemistry, and urinalysis for safety purposes will be performed at days 1, 3, 30, 60, 90 and 180 as well as at the time of premature discontinuation. Troponin testing will only be performed at day 1, 3, and 30.
CT scan will be performed at Day 30 and Day 180 to identify possible tissue reaction to PDT.
ECG will be performed at baseline, during the study treatment and Day 1 (24 hours) after study treatment. An additional ECG will be performed at 8 hours ± 15 minutes post-drug instillation to correspond with the 8 hour PK blood sample at Day 0.
Vital signs (blood pressure, heart rate, respiratory rate and temperature) will be recorded for safety purposes at every visit throughout treatment and at the end of study.
A comprehensive physical examination for safety purposes is required during Screening and at the Month 6/End of Study and End of Treatment.
Multiple measurements will be aggregated into number of abnormal results different from baseline for each subject.
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Love that it's all Estimated LOL
Basically to have 9 enrolled and to have a full 6 month follow up from date of treatment you need to
1. Have the 3 patients treated by April 1 (May 1 is 30 day followup)
2. Enrol 6 more and treat by June 1 for a Dec 1 finish.
I am largely skeptical of that..... indeed we would need that 0,0,0,6 canditate paradigm to come true.
Man, lets get started!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!1
I really don't understand what pharking stupid HC is doing, why take so long,they have already wasted 1 year for delayed approval for human trial after 2015 year end no objection letter, and now another delay in human trial could be expected, why on earth for these years 40k/yearly refugees acceptance so soon while the endless delays on a promising technology that could save millions and millions people ' s life .