Brief Summary
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with Primary Sclerosing Cholangitis.
Brief Title
A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.
Detailed Description
Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Primary Sclerosing Cholangitis (ALPINE-PSC)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Primary Sclerosing Cholangitis
Eligibility Criteria
Inclusion Criteria:
1. Able and willing to give informed consent
2. Confirmed diagnosis of PSC based on either:
1. Abnormal cholangiography consistent with PSC as measured by MRCP with contrast
2. Liver biopsy consistent with PSC
3. LSM by VCTE, indicative of at least F2 liver fibrosis stage
4. Laboratory parameters:
1. TBL ≤2.5 mg/dL unless known for Gilbert's Syndrome
2. ALT and ALT \<5x ULN
3. MELD score ≤12
Exclusion Criteria:
1. Clinically significant acute or chronic liver disease of an etiology other than PSC
2. Alternate causes of sclerosing cholangitis including IgG4 related sclerosing cholangitis
3. Subjects with moderate to severe hepatic impairment
4. Subjects with moderate to severe renal impairment
5. Placement of bile duct stent or percutaneous bile duct drain within 12 weeks of Screening
1. Able and willing to give informed consent
2. Confirmed diagnosis of PSC based on either:
1. Abnormal cholangiography consistent with PSC as measured by MRCP with contrast
2. Liver biopsy consistent with PSC
3. LSM by VCTE, indicative of at least F2 liver fibrosis stage
4. Laboratory parameters:
1. TBL ≤2.5 mg/dL unless known for Gilbert's Syndrome
2. ALT and ALT \<5x ULN
3. MELD score ≤12
Exclusion Criteria:
1. Clinically significant acute or chronic liver disease of an etiology other than PSC
2. Alternate causes of sclerosing cholangitis including IgG4 related sclerosing cholangitis
3. Subjects with moderate to severe hepatic impairment
4. Subjects with moderate to severe renal impairment
5. Placement of bile duct stent or percutaneous bile duct drain within 12 weeks of Screening
Inclusion Criteria
Inclusion Criteria:
1. Able and willing to give informed consent
2. Confirmed diagnosis of PSC based on either:
1. Abnormal cholangiography consistent with PSC as measured by MRCP with contrast
2. Liver biopsy consistent with PSC
3. LSM by VCTE, indicative of at least F2 liver fibrosis stage
4. Laboratory parameters:
1. TBL ≤2.5 mg/dL unless known for Gilbert's Syndrome
2. ALT and ALT \<5x ULN
3. MELD score ≤12
1. Able and willing to give informed consent
2. Confirmed diagnosis of PSC based on either:
1. Abnormal cholangiography consistent with PSC as measured by MRCP with contrast
2. Liver biopsy consistent with PSC
3. LSM by VCTE, indicative of at least F2 liver fibrosis stage
4. Laboratory parameters:
1. TBL ≤2.5 mg/dL unless known for Gilbert's Syndrome
2. ALT and ALT \<5x ULN
3. MELD score ≤12
Gender
All
Gender Based
false
Keywords
PSC
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT06654726
Org Class
Industry
Org Full Name
NGM Biopharmaceuticals, Inc
Org Study Id
282-PS-231
Overall Status
Withdrawn
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 2b/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of Aldafermin in Subjects With Primary Sclerosing Cholangitis (ALPINE-PSC).
Primary Outcomes
Outcome Description
Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome.
ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \> 7.7-9.8 is moderate, \> 9.8 is severe.
ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \> 7.7-9.8 is moderate, \> 9.8 is severe.
Outcome Measure
Change From Baseline in Enhanced Liver Fibrosis Score at Week 96
Outcome Time Frame
96 Weeks
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18