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A Randomized, Placebo-controlled, Single-blind, Parallel Design, Multi-center, Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)

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Trial Profile

A Randomized, Placebo-controlled, Single-blind, Parallel Design, Multi-center, Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Mar 2022

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At a glance

  • Drugs Tertomotide (Primary)
  • Indications Benign prostatic hyperplasia
  • Focus Therapeutic Use
  • Sponsors GemVax & KAEL

    • Most Recent Events

    • 06 Apr 2018 Primary endpoint (Evaluation of doses of GV1001 by comparing the level of change in IPSS scores in study group 3 to a control group at week 13.) has not been met as per the results published in the BJU International.
    • 06 Apr 2018 Primary endpoint (Evaluation of doses of GV1001 by comparing the level of change in IPSS scores in three study groups to a control group.) has not been met as per the results published in the BJU International.
    • 06 Apr 2018 Primary endpoint (Evaluation of doses of GV1001 by comparing the level of change in IPSS scores in study groups 1 and 2 to a control group at week 13.) has been met as per the results published in the BJU International.

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