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The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALE.F02 | Experimental | Patients will receive 3 doses of ALE.F02 administered once every second week as a continuous intravenous (IV) infusion to a total of 3 doses. |
|
| Placebo | Placebo Comparator | Patients will receive 3 doses of matching placebo administered once every second week as a continuous intravenous (IV) infusion to a total of 3 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALE.F02 | Drug | Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis. | Maximum Serum Concentration [Cmax] | Baseline to Day 14 and Day 29 to Day 72 |
| Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis. | Time of Maximum Serum Concentration [Tmax] | Baseline to Day 14 and Day 29 to Day 72 |
| Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis. | Area under the serum concentration versus time curve [AUC0-tau, AUC0-inf] | Baseline to Day 14 and Day 29 to Day 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis. | Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0 criteria Incidence of Serious Adverse Events assessed by CTCAE v5.0 criteria | Baseline to Day 72 |
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Principal Inclusion Criteria:
Principal Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Manenti, MD | Alentis Therapeutics AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Research Corporation | San Antonio | Texas | 78215 | United States | ||
| APEX GmbH |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Thirty-eight patients will receive 3 doses of ALE.F02 or matching placebo, administered once every second week as a continuous intravenous (IV) infusion to a total of 3 doses per patient at the same dose level. The 4 cohorts are enrolled in a staggered sequence and escalated upon review and approval of a Safety Review Committee: Cohort 1 (low dose) (4:2 active:placebo), Cohort 2 (intermediate dose) (8:4), Cohort 3 (intermediate dose) (8:2), Cohort 4 (high dose) (8:2).
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Double-blind
| Placebo | Drug | Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses. |
|
| Pharmacodynamic (PD) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis. |
Relative change (%) of serum levels of PRO-C3 between baseline and the EOT. Relative change (%) of serum levels of tissue inhibitor of matrix metalloproteinase [TIMP1] between baseline and the EOT. Relative change (%) of serum levels of hyaluronic acid between baseline and the EOT. Relative change (%) of serum levels of procollagen III amino-terminal peptide [PIIINP] between baseline and the EOT. |
| Baseline to Day 72 |
| Munich |
| 81241 |
| Germany |
| ARENSIA Exploratory Medicine S.R.L. | Bucharest | 011665 | Romania |
| ARENSIA Exploratory Medicine S.R.L. - Cluj-Napoca | Cluj-Napoca | 400006 | Romania |
| Summit Clinical Research | Bratislava | 851 05 | Slovakia |
| Summit Clinical Research | Malacky | 90122 | Slovakia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |