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

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GV1001 placebo
Proscar placebo
Sponsored by
GemVax & Kael
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Benign Prostatic Hyperplasia, GV1001

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. A male at 50 years of age and older

  2. Clinical signs and symptoms of benign prostatic hyperplasia

    1. A volume of prostate gland (TRUS) > 30 cc
    2. Moderate to severe lower urinary tract symptoms with IPSS ≥ 13
    3. 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL
  3. PSA level < 10 ng/mL (however, if 4 ng/mL < PSA < 10 ng/mL, a person with a biopsy result, confirming that he does not have prostate cancer)
  4. Residual urine volume ≤ 200 Ml
  5. Consent not to participate in other clinical trials as a subject during this clinical trial period.

  6. Consent of patient and patient's partner a. Patient

    • Consent to avoid pregnancy by using condoms for 90 days after the end of study participation period and treatment. (Not applied if the patient had vasectomy.) b. Patient's partner (Consent should be obtained before visit 4, when necessary.)
    • Consent to avoid pregnancy by using contraceptive devices or oral contraceptives during the patient's participation in clinical trial and for 90 days after the end of treatment, except if the partner reaches menopause or is surgically sterilized.

Exclusion Criteria:

  1. Hypersensitivity reactions to ingredients of this drug.
  2. Taking drugs that affect the results of clinical trials. ex) 5-alpha reductase inhibitors, drugs similar to LHRH, alpha blockers, alpha-beta blockers, anticholinergics, antidiuretic hormones, diuretics, PDE-5 inhibitors, beta-3 adrenoceptor antagonists, steroids, immune suppressants, saw palmetto, etc.
  3. Taking drugs of an unapproved study drug in the past or the study drug for this clinical trial
  4. Diagnosis with prostate cancer in the past or at present
  5. Diagnosis by an investigator to have an influence to an evaluation on urine flow symptoms due to other previous or current diseases besides benign prostatic hyperplasia
  6. Surgeries or radiation therapies for prostate gland, bladder or pelvis, or who had invasive treatments for benign prostatic hyperplasia
  7. Severe medical condition which may be cause problem to conduct the clinical trial (e.g., chronic heart failure (CHF), difficult-to-control diabetes (HbA1c > 7%), mental disorder, drug, or alcohol abuse, etc.)
  8. Moderate to severe liver hypofunction and severe kidney hypofunction (less than 30 mL/min of creatinine clearance)
  9. Any other subjects who are considered to be ineligible for this study by an investigator

[Inclusion Criteria for Randomization]

  1. Clinical signs and symptoms of benign prostatic hyperplasia

    1. Volume of prostate gland (TRUS) > 30 cc *
    2. moderate to severe lower urinary tract symptoms with IPSS ≥ 13
    3. 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL
  2. Residual urine volume ≤ 200 mL
  3. Patient's partner (Consent should be obtained before visit 4, when necessary.) - Consent to avoid pregnancy by using contraceptive devices or oral contraceptives during the patient's participation in clinical trial and for 90 days after the end of treatment, except if the partner reaches menopause or is surgically sterilized.

(* In case that additional TRUS examination has been performed after screening, a decision should be made based on the latest result.)

Sites / Locations

  • Hanyang University Guri Hospital
  • Seoul National University Bundang Hospital
  • Dongguk University Gyeongju Hospital
  • Hallym University Medical Center
  • Inje University Busan Paik Hospital
  • Samsung Changwon Medical Center
  • Soonchunhyang University Hospital
  • Chungbuk National University Hospital
  • Chonnam National University Hospital
  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Chilgok Hospital
  • Yeungnam University Medical Center
  • Dongguk University Ilsan Hospital
  • Jeonbuk National University Hospital
  • Asan Medical Center
  • Chung-ang University Hospital
  • Eulji General Hospital
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Severance Hospital
  • The Catholic University of Korea, Seoul ST. Mary's Hospital
  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group

Study Group 1

Study Group 2

Arm Description

GV1001-Placebo ID injection administered every 2 weeks through Week 24 + Proscar PO administered once a day through Week 24

GV1001 0.56 mg ID injection administered every 2 weeks through Week 24 + Proscar-placebo PO administered once a day through Week 24

GV1001 1.12 mg ID injection administered every 2 weeks through Week 24 + Proscar-placebo PO administered once a day through Week 24

Outcomes

Primary Outcome Measures

Change in International Prostate Symptom Score(IPSS)
The amount of change from International Prostate Symptom Score(IPSS )compared to the baseline. The measures of the 7 items evaluating symptoms is evaluated from 0 to 5 for each item, the total coverage range is from 0 (no symptoms) to 35 (most severe symptoms). And the quality of life assessment is assessed from 0 (very satisfactory) to 6 (very unsatisfactory).

Secondary Outcome Measures

Change in International Prostate Symptom Score(IPSS)
The amount of change from International Prostate Symptom Score(IPSS )compared to the baseline. The measures of the 7 items evaluating symptoms is evaluated from 0 to 5 for each item, the total coverage range is from 0 (no symptoms) to 35 (most severe symptoms). And the quality of life assessment is assessed from 0 (very satisfactory) to 6 (very unsatisfactory).
Change in voiding score of International Prostate Symptom Score(IPSS)
The amount of change from voiding score of IPSS compared to the baseline. The voiding score is measured as the sum of the evaluation scores of items 1, 3, 5 and 6 of the seven symptom scores of the IPSS.
Change in Prostatic Volume(PV)
The amount of change from Prostatic Volume(PV) compared to the baseline.
Change in Maximum(peak) Urinary Flow Rate
The amount of change from Maximum(peak) Urinary Flow Rate compared to the baseline
Change in Prostate-specific Antigen (PSA)
The amount of change from Prostate-specific Antigen (PSA) compared to the baseline
Change in Residual Urine Volume
The amount of change from Residual Urine Volume compared to the baseline
Change in Hormones (Testosterone, DHT)
The amount of change from Hormones (Testosterone, DHT) compared to the baseline
Change in International Index of Erectile Function (IIEF)
The amount of change from International Index of Erectile Function (IIEF) compared to the baseline
rate of incidence of Acute urinary tract(AUR)
The rate of incidence of Acute urinary tract(AUR), meaning clinical progression of prostate hypertrophy
Ratio of prostate surgery and minimally invasive (non-surgical) procedure
The ratio of prostate surgery and minimally invasive (non-surgical) procedure, meaning clinical progression of prostate hypertrophy

Full Information

First Posted
July 19, 2019
Last Updated
August 24, 2022
Sponsor
GemVax & Kael
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1. Study Identification

Unique Protocol Identification Number
NCT04032067
Brief Title
Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GemVax & Kael

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH)
Keywords
Benign Prostatic Hyperplasia, GV1001

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
423 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
GV1001-Placebo ID injection administered every 2 weeks through Week 24 + Proscar PO administered once a day through Week 24
Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
GV1001 0.56 mg ID injection administered every 2 weeks through Week 24 + Proscar-placebo PO administered once a day through Week 24
Arm Title
Study Group 2
Arm Type
Experimental
Arm Description
GV1001 1.12 mg ID injection administered every 2 weeks through Week 24 + Proscar-placebo PO administered once a day through Week 24
Intervention Type
Drug
Intervention Name(s)
GV1001 placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
0.9 % Normal Saline
Intervention Type
Drug
Intervention Name(s)
Proscar placebo
Other Intervention Name(s)
Finasteride
Intervention Description
PO
Primary Outcome Measure Information:
Title
Change in International Prostate Symptom Score(IPSS)
Description
The amount of change from International Prostate Symptom Score(IPSS )compared to the baseline. The measures of the 7 items evaluating symptoms is evaluated from 0 to 5 for each item, the total coverage range is from 0 (no symptoms) to 35 (most severe symptoms). And the quality of life assessment is assessed from 0 (very satisfactory) to 6 (very unsatisfactory).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change in International Prostate Symptom Score(IPSS)
Description
The amount of change from International Prostate Symptom Score(IPSS )compared to the baseline. The measures of the 7 items evaluating symptoms is evaluated from 0 to 5 for each item, the total coverage range is from 0 (no symptoms) to 35 (most severe symptoms). And the quality of life assessment is assessed from 0 (very satisfactory) to 6 (very unsatisfactory).
Time Frame
Weeks 4, 8, 12, 16 and 20
Title
Change in voiding score of International Prostate Symptom Score(IPSS)
Description
The amount of change from voiding score of IPSS compared to the baseline. The voiding score is measured as the sum of the evaluation scores of items 1, 3, 5 and 6 of the seven symptom scores of the IPSS.
Time Frame
Weeks 4, 8, 12, 16, 20 and 24
Title
Change in Prostatic Volume(PV)
Description
The amount of change from Prostatic Volume(PV) compared to the baseline.
Time Frame
Weeks 12 and 24
Title
Change in Maximum(peak) Urinary Flow Rate
Description
The amount of change from Maximum(peak) Urinary Flow Rate compared to the baseline
Time Frame
Weeks 12 and 24
Title
Change in Prostate-specific Antigen (PSA)
Description
The amount of change from Prostate-specific Antigen (PSA) compared to the baseline
Time Frame
Weeks 12 and 24
Title
Change in Residual Urine Volume
Description
The amount of change from Residual Urine Volume compared to the baseline
Time Frame
Weeks 12 and 24
Title
Change in Hormones (Testosterone, DHT)
Description
The amount of change from Hormones (Testosterone, DHT) compared to the baseline
Time Frame
Weeks 4, 8, 12, 16, 20 and 24
Title
Change in International Index of Erectile Function (IIEF)
Description
The amount of change from International Index of Erectile Function (IIEF) compared to the baseline
Time Frame
Weeks 4, 8, 12, 16, 20 and 24
Title
rate of incidence of Acute urinary tract(AUR)
Description
The rate of incidence of Acute urinary tract(AUR), meaning clinical progression of prostate hypertrophy
Time Frame
Every 2 weeks After screening visit up to 24 week
Title
Ratio of prostate surgery and minimally invasive (non-surgical) procedure
Description
The ratio of prostate surgery and minimally invasive (non-surgical) procedure, meaning clinical progression of prostate hypertrophy
Time Frame
Every 2 weeks After screening visit up to 24 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A male at 50 years of age and older Clinical signs and symptoms of benign prostatic hyperplasia A volume of prostate gland (TRUS) > 30 cc Moderate to severe lower urinary tract symptoms with IPSS ≥ 13 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL PSA level < 10 ng/mL (however, if 4 ng/mL < PSA < 10 ng/mL, a person with a biopsy result, confirming that he does not have prostate cancer) Residual urine volume ≤ 200 Ml Consent not to participate in other clinical trials as a subject during this clinical trial period. Consent of patient and patient's partner a. Patient Consent to avoid pregnancy by using condoms for 90 days after the end of study participation period and treatment. (Not applied if the patient had vasectomy.) b. Patient's partner (Consent should be obtained before visit 4, when necessary.) Consent to avoid pregnancy by using contraceptive devices or oral contraceptives during the patient's participation in clinical trial and for 90 days after the end of treatment, except if the partner reaches menopause or is surgically sterilized. Exclusion Criteria: Hypersensitivity reactions to ingredients of this drug. Taking drugs that affect the results of clinical trials. ex) 5-alpha reductase inhibitors, drugs similar to LHRH, alpha blockers, alpha-beta blockers, anticholinergics, antidiuretic hormones, diuretics, PDE-5 inhibitors, beta-3 adrenoceptor antagonists, steroids, immune suppressants, saw palmetto, etc. Taking drugs of an unapproved study drug in the past or the study drug for this clinical trial Diagnosis with prostate cancer in the past or at present Diagnosis by an investigator to have an influence to an evaluation on urine flow symptoms due to other previous or current diseases besides benign prostatic hyperplasia Surgeries or radiation therapies for prostate gland, bladder or pelvis, or who had invasive treatments for benign prostatic hyperplasia Severe medical condition which may be cause problem to conduct the clinical trial (e.g., chronic heart failure (CHF), difficult-to-control diabetes (HbA1c > 7%), mental disorder, drug, or alcohol abuse, etc.) Moderate to severe liver hypofunction and severe kidney hypofunction (less than 30 mL/min of creatinine clearance) Any other subjects who are considered to be ineligible for this study by an investigator [Inclusion Criteria for Randomization] Clinical signs and symptoms of benign prostatic hyperplasia Volume of prostate gland (TRUS) > 30 cc * moderate to severe lower urinary tract symptoms with IPSS ≥ 13 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL Residual urine volume ≤ 200 mL Patient's partner (Consent should be obtained before visit 4, when necessary.) - Consent to avoid pregnancy by using contraceptive devices or oral contraceptives during the patient's participation in clinical trial and for 90 days after the end of treatment, except if the partner reaches menopause or is surgically sterilized. (* In case that additional TRUS examination has been performed after screening, a decision should be made based on the latest result.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Seop Lee
Organizational Affiliation
Department of Urology, Dongguk University Gyeongju Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Dongguk University Gyeongju Hospital
City
Gyeongju
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Facility Name
Hallym University Medical Center
City
Anyang
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Samsung Changwon Medical Center
City
Changwon
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Chungbuk
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Chungnam
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Dongguk University Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Jeonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Eulji General Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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