A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH
- Registration Number
- NCT02855892
- Lead Sponsor
- GemVax & Kael
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 161
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Placebo - Placebo, two-week interval, intradermal administration Study Group 3 Placebo - 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.) Study Group 1 GV1001 - GV1001 0.4 mg, two-week interval, intradermal administration Study Group 2 GV1001 - GV1001 0.56 mg, two-week interval, intradermal administration Study Group 3 GV1001 - 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.)
- Primary Outcome Measures
Name Time Method Evaluation of doses of GV1001 by comparing the level of change in IPSS scores in three study groups to a control group. at Week 0, 4, 8, 12, 13, and 16 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.
- Secondary Outcome Measures
Name Time Method Change in volume of prostate gland (TRUS) compared to the baseline at screening and Week 16 The amount of change from Transrectal Ultrasonography(TRUS) compared to the baseline
Change in International Index of Erectile Function (IIEF) compared to the baseline at Week 0, 4, 8, 12, 13, and 16 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.
Change in maximum flow rate (Qmax) compared to the baseline at Week 0, 4, 8, 12, 13, and 16 The amount of change from Maximum(peak) Urinary Flow Rate compared to the baseline
Change in prostate-specific antigen (PSA) compared to the baseline at Week 0, 13, and 16 The amount of change from Prostate-specific Antigen (PSA) compared to the baseline
Change in residual urine volume compared to the baseline at Week 0, 4, 8, 12, 13, and 16 The amount of change from Residual Urine Volume compared to the baseline
Change in hormones (testosterone, DHT) compared to the baseline at Week 0, 4, 8, 12, 13, and 16 The amount of change from Hormones (Testosterone, DHT) compared to the baseline
Trial Locations
- Locations (8)
Eulji General Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-si, Gyeonggi-do, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Dongguk University Gyeongju Hospital
🇰🇷Gyeongju, Gyeongsangbuk-do, Korea, Republic of
Chung-ang University Hospital
🇰🇷Seoul, Korea, Republic of