A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH

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)

This clinical trial is designed as a randomized, placebo-controlled, single-blind, parallel design, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of GV1001 in patients with benign prostatic hyperplasia. Eligible subjects are randomized into a group out of the three study groups and a placebo group after four weeks of placebo run-in period. Placebo run-in period is concurrently proceeded as a wash-out period for previous treatment of benign prostatic hyperplasia, and a placebo is administered intradermally twice with two-week interval during this period. After that, the randomized subjects receive a study drug and a placebo intradermally seven times with two-week interval by visiting at Week 0, 2, 4, 6, 8, 10, and 12. After the treatment period, the subjects additionally visit at Week 13 and 16, and the efficacy is evaluated at Week 4, 8, 12, 13, and 16, and the safety is evaluated over the 16-week period.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Other: Placebo; Drug: GV1001

Detailed Description

Patients will be randomized equally between the four arms.

1. Control group (placebo, two-week interval): 38 subjects
2. Study group 1 (GV1001 0.4 mg, intradermal administration, two-week interval): 38 subjects
3. Study group 2 (GV1001 0.56 mg, intradermal administration, two-week interval): 38 subjects
4. Study group 3 (GV1001 0.56 mg, intradermal administration, four-week interval): 38 subjects

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Seoul, Korea, Republic of
    • Eulji General Hospital
  • Seoul, Korea, Republic of
    • Chung-ang University Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Gyeonggi-do
    • Guri-si, Gyeonggi-do, Korea, Republic of
      • Hanyang University Guri Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Seoul National University Bundang Hospital
  • Gyeongsangbuk-do
    • Gyeongju, Gyeongsangbuk-do, Korea, Republic of
      • Dongguk university gyeongju hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

[Inclusion Criteria]

All of the following criteria should be satisfied to be enrolled in this clinical trial.

1. A male at 50 years of age and older

2. A patient who satisfies the following clinical signs and symptoms of benign prostatic hyperplasia

   ① A patient with a volume of prostate gland (TRUS) > 30 cc

   ② A patient with moderate to severe lower urinary tract symptoms with IPSS ≥ 13

   ③ A patient with 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL

3. A patient with 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. A patient with residual urine volume ≤ 200 mL
5. A patient with intention of not using drugs which may affect benign prostatic hyperplasia (5-alpha reductase inhibitors, drugs similar to LHRH, alpha blockers, alpha-beta blockers, anticholinergics, antidiuretic hormones, diuretics, PDE-5 inhibitors, beta-3 adrenoceptor antagonists, etc.), drugs affecting immune system (steroids, immunosuppressants), or health functional foods which may affect a prostate gland (saw palmetto, etc.) during the clinical trial period
6. A patient has to consent not to participate in other clinical trials as a subject during this clinical trial period.
7. Before enrollment to the study, a patient has to consent to avoid pregnancy by using condoms for 90 days after the end of study participation period and treatment. (However, this is not applied if the patient had vasectomy.) Also, a partner of the patient has to 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. (Consent should be obtained before visit 4, when necessary.)

[Exclusion Criteria]

If any one of the following is applied, a patient cannot be enrolled in this clinical trial.

1. A patient who has hypersensitivity reactions to ingredients of this drug.
2. A patient who received 5-alpha reductase inhibitors other than a drug used in this clinical trial before randomization (within six months)
3. A patient who received drugs similar to LHRH other than a drug used in this clinical trial
4. A patient who has received an unapproved study drug in the past or the study drug for this clinical trial (One exception: a patient can be enrolled when the drug is considered by an investigator not to affect prostate and urinary function, and the patient is not participating in other ongoing clinical trial.)
5. If diagnosed with prostate cancer in the past or at present
6. A patient who was considered 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 (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder cancer, malignant tumor in lower urinary tract, etc.)
7. A patient who had surgeries or radiation therapies for prostate gland, bladder or pelvis, or who had invasive treatments for benign prostatic hyperplasia
8. A patient who has 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.)
9. A patient with moderate to severe liver hypofunction and severe kidney hypofunction (less than 30 mL/min of creatinine clearance)
10. A patient who receives drugs affecting immune system (e.g., immunosuppressives, steroids for systemic action, etc.)
11. Any other patients who are considered to be ineligible for this study by an investigator

[Inclusion Criteria for Randomization]

1. A patient who satisfies the following clinical signs and symptoms of benign prostatic hyperplasia

   ① A patient with a volume of prostate gland (TRUS) > 30 cc *

   ② A patient with moderate to severe lower urinary tract symptoms with IPSS ≥ 13

   ③ A patient with 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL

2. A patient with residual urine volume ≤ 200 mL
3. A partner of the patient has to 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control Group; - Placebo, two-week interval, intradermal administration	Other: Placebo; Other Names: Normal Saline 0.9 %
EXPERIMENTAL: Study Group 1; - GV1001 0.4 mg, two-week interval, intradermal administration	Drug: GV1001; Other Names: Tertomotide
EXPERIMENTAL: Study Group 2; - GV1001 0.56 mg, two-week interval, intradermal administration	Drug: GV1001; Other Names: Tertomotide
EXPERIMENTAL: Study Group 3; - GV1001 0.56 mg, four-week interval, intradermal administration : Should be visited every two weeks (GV1001 0.56 mg or placebo is administered alternately at every visit.)	Other: Placebo; Other Names: Normal Saline 0.9 %; Drug: GV1001; Other Names: Tertomotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of doses of GV1001 by comparing the level of change in IPSS scores in three study groups to a control group.	IPSS questionnaire: 7-item questionnaire that measures urinary symptoms, but with an additional, independent eighth question on quality of life. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. The first 7 items has a 6-point response scale (0=none/never to 5=almost always/5 or more times) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). The last item assesses quality of life reported as a Quality of Life assessment index.	at Week 0, 4, 8, 12, 13, and 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in volume of prostate gland (TRUS) compared to the baseline	The amount of change from Transrectal Ultrasonography(TRUS) compared to the baseline	at screening and Week 16
Change in maximum flow rate (Qmax) compared to the baseline	The amount of change from Maximum(peak) Urinary Flow Rate compared to the baseline	at Week 0, 4, 8, 12, 13, and 16
Change in International Index of Erectile Function (IIEF) compared to the baseline	IIEF questionnaire: 15-item, 5 domain scale collected by subject interview, relating to the subjects' experience of erectile function (and other sexual parameters) over the previous 4 weeks.	at Week 0, 4, 8, 12, 13, and 16
Change in prostate-specific antigen (PSA) compared to the baseline	The amount of change from Prostate-specific Antigen (PSA) compared to the baseline	at Week 0, 13, and 16
Change in residual urine volume compared to the baseline	The amount of change from Residual Urine Volume compared to the baseline	at Week 0, 4, 8, 12, 13, and 16
Change in hormones (testosterone, DHT) compared to the baseline	The amount of change from Hormones (Testosterone, DHT) compared to the baseline	at Week 0, 4, 8, 12, 13, and 16

Collaborators and Investigators

• Sponsor: GemVax & Kael

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (ESTIMATE): August 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: BPH; Benign prostatic hyperplasia; GV1001
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: KG 3/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No