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Friday, 02/02/2018 12:30:04 AM

Friday, February 02, 2018 12:30:04 AM

Post# of 50118
Updated trial information on the clinical trials.gov website
Just checking in on the trials, and I see they also updated the trial info as of January 31, 2018
If I am not mistaken, the original required number of participants were 240, and now it reflects only a requirement of 200 participants. That is also great news for the company, and a huge positive when it comes to getting the trial done and FDA approval!

Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP With the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
Actual Study Start Date : January 14, 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019



Expect study completion by February 2019. With the relaxed enrollment criteria, and lower number of participants required. Who knows how close they are to reaching that 200th patient? also, this is not a blinded trial, so the company should know the 30-day results of those patients treated already. This and the fact that the Independent Safety Monitoring Committee recommended continuation without modifications tells me that things are going well! Had there been any adverse effects, the committee would have recommended discontinuing.
I am a believer of good things to come here, and that time is nearing!
IMHO

In My Own Personal Opinion Of Course!


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