Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04032067

Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:
A Randomized, Active-Controlled, Double-Blind, Parallel Design, Multi-Center, Phase III Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)

Clinical Trial Summary

The current study is being conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered as a treatment for Benign prostate hyperplasia(BPH). The investigational drug, GV1001, was first developed as a cancer vaccine for use as active immunotherapy of cancer forms expressing telomerase (eg, pancreatic cancer, prostate cancer, etc.). Subsequently, it was found that GV1001 showed efficacy in alleviating BPH symptoms during in vivo studies by reducing the size of the prostate gland. Based on the result, the effectiveness of GV1001 as a treatment for BPH has been assessed in experimental animals that are designed to develop BPH. It is considered that GV1001 acts to alleviate BPH and the results obtained from previous phase II study indicate that GV1001 may provide potential beneficial effects in BPH patients. So this study is to verify the efficacy and safety of GV1001 on BPH population, large-scale clinical study than phase II.

Clinical Trial Description

This was a multi-center, randomized, Double-blind, Active-controlled, parallel design, Phase 3 study in patients with BPH. The study consisted of a Screening period, a 4-weeks Run-in/Washout period, a 24-week Treatment period, an Evaluation and Close-out Visit at Week 24. There are a total of 3 groups in this study, which contained 2 study groups (GV1001) and 1 placebo group (0.9% normal saline). Approximately 417 patients are planned to be randomly assigned into the study in a 1:1:1 ratio. All patients are randomized into 1 of 3 treatment groups to ensure completion of patients. The Screening period have a time period of 4 weeks before the beginning of Run-in/Washout period. Eligible patients entered into a 4-week Run-in/Washout period and receive placebo treatment, which will be completed before randomization on Week 0. All randomized patients will receive the investigational drug or a placebo via intradermal injection 12 times with a 2-week interval at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24. Efficacy evaluation will be conducted at Weeks 4, 8, 12, 16, 20 and 24, and safety evaluation will be conducted throughout the 24-weeks period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04032067
Study type Interventional
Source GemVax & Kael
Contact
Status Completed
Phase Phase 3
Start date October 30, 2019
Completion date March 17, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT03052049 - Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres N/A
Recruiting NCT04757116 - Post-Market Study to Assess iTind Safety in Comparison to UroLift N/A
Completed NCT03460873 - Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
Completed NCT01218243 - An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia Phase 2
Completed NCT01566292 - Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy Phase 2/Phase 3
Active, not recruiting NCT00407953 - PROLIEVE® Post-Marketing Study TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) Phase 4
Completed NCT03191734 - French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue N/A
Recruiting NCT04838769 - REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men N/A
Completed NCT03856242 - Benign Prostatic Hyperplasia and Ischemic Heart DIsease Phase 4
Completed NCT02505919 - Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) N/A
Completed NCT02855892 - A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH Phase 2
Completed NCT02145208 - Study to Assess the Efficacy of Medi-Tate iTind Device N/A
Completed NCT00970632 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Phase 3
Recruiting NCT02592473 - Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia N/A
Completed NCT00945490 - Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018 Phase 3
Completed NCT00759135 - Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate) Phase 2
Completed NCT00224107 - A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo Phase 3
Recruiting NCT04648176 - Application of MOSES Technology in BPH N/A
Terminated NCT00651807 - A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806) Phase 2
Recruiting NCT04766268 - Prostate Artery Embolization: Single Center Experience N/A