|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 August 2021 |
|
Main ID: |
NCT03359174 |
|
Date of registration:
|
27/11/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis
|
|
Scientific title:
|
An Efficacy Trial of Low Dose All-trans Retinoic Acid (ATRA) in Patients With Primary Sclerosing Cholangitis |
|
Date of first enrolment:
|
May 29, 2018 |
|
Target sample size:
|
2 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT03359174 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
James Boyer, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Yale University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Males and females ages 18-80
- Diagnosis of large-duct PSC based on ERCP or MRCP, or liver biopsy findings without
alternative explanation for findings, for at least 6 months.
- Serum ALP levels persistently more than 1.5 x upper limit of normal over the past 6
months.
- Ursodeoxycholic acid therapy must be discontinued for at least 3 months.
- At least 2 forms of barrier protection for males and females of child-bearing age.
Exclusion Criteria:
- Small duct PSC, overlap with autoimmune hepatitis, IgG4 disease or secondary
sclerosing cholangitis.
- Any malignancy, presently or within the past 5 years, except adequately treated
non-melanoma skin cancer, carcinoma in situ of the cervix or in situ prostate cancer.
- Viral hepatitis including hepatitis A, B, C, D, E.
- Decompensated cirrhosis, or planned liver transplantation.
- Recent diagnostic or therapeutic biliary manipulation (endoscopic, radiologic) within
the past 3 months.
- Ascending Cholangitis requiring antibiotics within the past 3 months.
- Uncontrolled IBD, or IBD requiring the use of steroids.
- Acute or Chronic Kidney Disease with serum creatinine > 2 mg/dL.
- Allergy to ATRA or vitamin A compounds.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cholangitis, Sclerosing
|
|
Intervention(s)
|
|
Drug: All-trans retinoic acid
|
|
Primary Outcome(s)
|
|
Change of Serum Alkaline Phosphatase (ALP)
[Time Frame: Baseline to week 24.]
|
|
Secondary Outcome(s)
|
|
The Percent of Patients Who Have Reduction of Serum C4 by 50%
[Time Frame: Baseline to week 24.]
|
|
The Percent of Patients Who Have Reduction of Serum Alanine Aminotransferase (ALT) by 50%
[Time Frame: Baseline to week 24.]
|
|
The Percent of Patients Who Have Improvement in Fibrosis Per Transient Elastography by at Least 1 Stage
[Time Frame: Baseline to week 24.]
|
|
Change in Patients Who Have Normalization of Serum ALP or Reduction to Less Than 1.5 x Upper Limit of Normal (ULN)
[Time Frame: Baseline to week 24.]
|
|
The Percent of Patients Who Have Reduction of Serum Bile Acids by 50%
[Time Frame: Baseline to week 24.]
|
|
The Percent of Patients Who Have Reduction of Serum Enhanced Liver Fibrosis Score (ELF) by 10%
[Time Frame: Baseline to week 24.]
|
|
Secondary ID(s)
|
|
2000021447
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|