Clinical trial NCT02855892: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: GV1001
BPH
Benign prostatic hyperplasia
Lead sponsor: GemVax & Kael
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 161
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: \[Inclusion Criteria\]

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.)

Primary outcomes:
measure: Evaluation of doses of GV1001 by comparing the level of change in IPSS scores in three study groups to a control group.
timeFrame: at Week 0, 4, 8, 12, 13, and 16
Secondary outcomes:
measure: Change in volume of prostate gland (TRUS) compared to the baseline
timeFrame: at screening and Week 16
measure: Change in maximum flow rate (Qmax) compared to the baseline
timeFrame: at Week 0, 4, 8, 12, 13, and 16
measure: Change in International Index of Erectile Function (IIEF) compared to the baseline
timeFrame: at Week 0, 4, 8, 12, 13, and 16
measure: Change in prostate-specific antigen (PSA) compared to the baseline
timeFrame: at Week 0, 13, and 16
measure: Change in residual urine volume compared to the baseline
timeFrame: at Week 0, 4, 8, 12, 13, and 16
measure: Change in hormones (testosterone, DHT) compared to the baseline
timeFrame: at Week 0, 4, 8, 12, 13, and 16
Other outcomes:
Locations:
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Gyeongju
country: Korea, Republic of
facility: Dongguk University Gyeongju Hospital
state: Gyeongsangbuk-do
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Department of Urology, Dongguk University Gyeongju Hospital
name: Kyung Seop Lee
role: STUDY_CHAIR
References: