Chronic Liver Disease
Conditions
Brief summary
Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml)
Detailed description
This is a multi- center, randomized, open-label, Active-controlled phase 3 trial in participants aged 18 to 70 years with chronic liver disease. It is designed to assess the safety, tolerability and efficacy of both 4 ml SC and 10ml IV LAENNEC when administered twice of week for 6 weeks. A total of 226 participants will be randomised to received 4ml SC or 10ml IV of LAENNEC a 1:1 ratio. And in 4 ml SC and 10 ml IV, the ratio of ALD and NAFLD is 1:3. The investigational product will be administered SC or IV twice of week for a duration of 6 weeks. Participants will return to the clinic for follow-up safety and efficacy assessments on weeks 2, 4, 6.
Interventions
DRUGLAENNEC (Human Placenta Hydrolysate) IV
Intravenous Injection
DRUGLAENNEC (Human Placenta Hydrolysate) SC
Subcutaneous Injection
Sponsors
Green Cross Wellbeing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
A participant will be eligible for participation in the trial if all of the following inclusion criteria are met: 1. At the time of screening, 19 or 70 years 2. Those who have been diagnosed with alcoholic or non-alcoholic fatty liver disease 3. Those who have increased ALT level (Increased ALT level : 60 IU/L ≤ ALT ≤ 200 IU/L) 4. A person who can complete the signature agreement and comply with clinical trial requirements.
Exclusion criteria
A participant will not be eligible for trial participation if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ALT level relative to baseline at 6 weeks | week 6 | In order to compare the test groups and control groups, check the ALT change after 6 weeks compared to the baseline. For the 6 week ALT change amount, a civic analysis (ANCOVA) is performed with the ALT level of the base line and the tamed dynasty (alcohol liver disease/non -alcohol liver liver disease) in a covenant. In addition, depending on the normal distribution of the data, the Paired t-test or Wilcoxon's rank test is performed to confirm the difference in the average change in the military. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ALT level relative to baseline at 2, 4 weeks | week 2, 4 | In order to compare the test groups and control groups, check the ALT change after 2,4 weeks compared to the baseline. For the 2,4 weeks ALT change amount, a civic analysis (ANCOVA) is performed with the ALT level of the base line and the tamed dynasty (alcohol liver disease/non -alcohol liver liver disease) in a covenant. In addition, depending on the normal distribution of the data, the Paired t-test or Wilcoxon's rank test is performed to confirm the difference in the average change in the military. |
| Change in AST, Total Bilirubin and r-GT level relative to baseline at 2, 4, 6 weeks | week 2, 4, 6 | In order to compare the test groups and control groups, check the AST, Total Bilirubin and r-GT change after 2,4,6 weeks compared to the baseline. For the 2, 4, 6 weeks AST, Total Bilirubin and r-GT change amount, a civic analysis (ANCOVA) is performed with the ALT level of the base line and the tamed dynasty (alcohol liver disease/non -alcohol liver liver disease) in a covenant. In addition, depending on the normal distribution of the data, the Paired t-test or Wilcoxon's rank test is performed to confirm the difference in the average change in the military. |
| The rate of ALT normalization at 2, 4, 6 weeks | week 2, 4, 6 | Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the ALT normal level at 2, 4, 6 weeks. |
| The rate of AST normalization at 2, 4, 6 weeks | week 2, 4, 6 | Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the AST normal level at 2, 4, 6 weeks. |
| ALT normalization time | during 6 week | It presents the time to normalize the ALT of the test group and the control group, and checks the difference between the test group and the control group using the log order test. |
| The Rate of participants with ≤ 20% decrease of ALT relative to baseline at 2, 4 weeks | week 2, 4, 6 | Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the ≤ 20% decrease of ALT relative to baseline at 2, 4, 6 weeks. |
| Change in FSS score relative to baseline at 6 weeks | week 6 | In order to compare the test groups and control groups, check the FSS change after 6 week compared to the baseline. For the 6 week FSS change amount, a civic analysis (ANCOVA) is performed with the ALT level of the base line and the tamed dynasty (alcohol liver disease/non -alcohol liver liver disease) in a covenant. In addition, depending on the normal distribution of the data, the Paired t-test or Wilcoxon's rank test is performed to confirm the difference in the average change in the military. |
Countries
South Korea
Contacts
CONTACTYeongmin Kwon
STUDY_DIRECTORSeung Up Kim, Ph.D.
50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
STUDY_DIRECTOREileen Laurel Yoon, Ph.D.
222-1, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea
STUDY_DIRECTORSang Gyune Kim, Ph.D.
170, Jomaru-ro, Wonmi-gu, Bucheon-si, Gyeonggi-do, Republic of Korea
STUDY_DIRECTORYuri Cho, Ph.D.
323, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea
STUDY_DIRECTORJung Hwan Yu, Ph.D.
27, Inhang-ro, Jung-gu, Incheon, Republic of Korea
STUDY_DIRECTORWon Sohn, Ph.D.
29, Saemunan-ro, Jongno-gu, Seoul, Republic of Korea
STUDY_DIRECTORSoo Young Park, Ph.D.
807, Hoguk-ro, Buk-gu, Daegu, Republic of Korea
STUDY_DIRECTORByoung Kuk Jang, Ph.D.
1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea
STUDY_DIRECTORSoung Won Jeong, Ph.D.
59, Daesagwan-ro, Yongsan-gu, Seoul, Republic of Korea
STUDY_DIRECTORYoung Youn Cho, Ph.D.
102, Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea
STUDY_DIRECTOREun Ju Cho, Ph.D.
101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea
STUDY_DIRECTORJung Gil Park, Ph.D.
70, Hyeonchung-ro, Nam-gu, Daegu, Republic of Korea
STUDY_DIRECTORJung Hyun Kwon, Ph.D.
56, Dongsu-ro, Bupyeong-gu, Incheon, Republic of Korea
STUDY_DIRECTORYoung Kul Jung, Ph.D.
123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea
STUDY_DIRECTORJa Kyung Kim, Ph.D.
363, Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
STUDY_DIRECTORHyun Woong Lee, Ph.D.
211, Eonju-ro, Gangnam-gu, Seoul, Republic of Korea
STUDY_DIRECTORWon Hyeok Choe, Ph.D.
120-1, Neungdong-ro, Gwangjin-gu, Seoul, Republic of Korea
STUDY_DIRECTORChun Kyon Lee, Ph.D.
100, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea
Outcome results
None listed