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Trial record 1 of 1 for:    NCT05642468
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Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis

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ClinicalTrials.gov Identifier: NCT05642468
Recruitment Status : Recruiting
First Posted : December 8, 2022
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Albireo

Study Description
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Brief Summary:
This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC).

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: A3907 Phase 2

Detailed Description:
The primary goal of this study in participants with PSC who are treated with A3907 is to assess the safety and tolerability of A3907 following repeat doses. Secondary goals include evaluation of the pharmacokinetic properties of A3907 (the study of how the body interacts with A3907 for the entire duration of exposure) and changes in safety parameters via laboratory testing such as liver enzymes, bile acid levels and markers of bile acid synthesis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase 2 Study to Evaluate the Effect of A3907 on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults With Primary Sclerosing Cholangitis (PSC)
Actual Study Start Date : January 23, 2023
Estimated Primary Completion Date : June 17, 2024
Estimated Study Completion Date : June 17, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 10 mg (Arm 1)
10mg tablet A3907 administered orally once daily for 12 weeks.
 Drug: A3907
A3907 is an oral, systemically available, potent inhibitor of the apical sodium bile acid transporter (ASBT).
Experimental: 30 mg (Arm 2)
30mg (3x10 mg tablets) A3907 administered orally once daily for 12 weeks.
 Drug: A3907
A3907 is an oral, systemically available, potent inhibitor of the apical sodium bile acid transporter (ASBT).


Outcome Measures
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Primary Outcome Measures :
  1. Treatment related adverse events [ Time Frame: From baseline through week 12 ]
    Number of participants with treatment related adverse events as assessed by CTCAE v 5.0


Secondary Outcome Measures :
  1. Area under the Plasma Concentration versus Time Curve (AUC) of A3907 [ Time Frame: From baseline through week 12 ]
  2. Change in serum and urine individual and total bile acid levels [ Time Frame: From baseline through week 12 ]
  3. Change in ALT, AST, gamma-glutamyltransferase (GGT), ALP and bilirubin levels [ Time Frame: From baseline through week 12 ]
  4. Change in serum C4 level [ Time Frame: From baseline through week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion criteria:

  • Clinical and radiological diagnosis of large-duct PSC via magnetic resonance cholangiopancreatography movement-related cortical potential (MRCP) or equivalent imaging modality that excludes biliary obstruction and malignancy within 6 months before screening
  • Alkaline phosphatase (ALP) > 1.5 × upper limit of normal (ULN) but ≤ 10 × ULN
  • Total bilirubin < 3 × ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × ULN
  • Baseline serum bile acid level at Screening must be > ULN
  • Clinically stable for at least 3 months prior to screening

Key exclusion criteria:

  • Presence of documented secondary sclerosing cholangitis, small duct PSC, known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis or other causes of chronic liver disease
  • Biliary intervention within 3 months prior to study enrollment or planned
  • Inflammatory bowel disease (IBD) with uncontrolled moderate to severe activity and/or on treatment with any immunosuppressive, immunomodulator, or biologic agent for treatment of IBD. Treatment with corticosteroids in the previous 4 weeks
  • History of human immunodeficiency virus infection or any other known relevant infection (e.g., tuberculosis)
  • History of colostomy or colectomy
  • History of malignancy, including hepatocellular carcinoma within the past 10 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
  • History of transplants, including liver transplantation, or currently on active transplantation list
  • Known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis

  • Liver cirrhosis as assessed by any of the following:

    1. historical liver histology suspected liver fibrosis
    2. liver stiffness measurement, assessed by FibroScan (FibroScan value > 14.4 kPa)
    3. current or history of signs and symptoms of hepatic decompensation (including, but not limited to, jaundice, ascites, variceal haemorrhage, and/or hepatic encephalopathy)
  • Treatment with rifampicin, CYP3A4 substrates, vitamin D or fibrates (unless patient is on a stable dose ≥ 6 months prior to baseline) and with medications that slow gastrointestinal motility
  • Exposure to an investigational drug, biologic agent, or medical device within 30 days prior to Screening, or 5 half-lives of the study agent, whichever is longer
  • Platelet count < 150 000/mm3
  • Albumin level < 3.0 g/dL
  • International normalised ratio (INR) > 1.4 (the patient may be treated with vitamin K intravenously, and if INR is ≤ 1.4 at resampling, the patient may be enrolled)
  • Advanced renal disease glomerular filtration rate (GFR) <70 mL/min/1.73 m2)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05642468


Contacts
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Contact: Albireo +1(857) 378-2035 medinfo@albireopharma.com

Locations
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France
Hopital Saint Antoine Recruiting
Paris, France, 75012
Contact: Karima Ben Belkacem    +33149282380    karima.benbelkacem@aphp.fr   
Principal Investigator: Olivier Chazouilleres, MD         
Italy
ASST di Monza - Azienda Ospedaliera San Gerardo Recruiting
Monza, Italy, 20900
Contact: Gabriella Marsoni    +390392333962    g.marsoni.sc@gmail.com   
Contact: Riccardo Artuso    +390392334598    r.artusosc@gmail.com   
Principal Investigator: Marco Carbone, MD         
Azienda Ospedale Università Padova Recruiting
Padova, Italy, 35128
Contact: Emanuela Bonaiuto    +390498215611    emanuela.bonaiuto@gmail.com   
Principal Investigator: Nora Cazzagon, MD         
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 8036
Contact: Cristina Marti    +34697267846    cmartid@clinic.cat   
Principal Investigator: María Carlota Londoño Hurtado, MD         
Sponsors and Collaborators
Albireo
More Information
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Responsible Party: Albireo
ClinicalTrials.gov Identifier: NCT05642468    
Other Study ID Numbers: A3907-002
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Albireo:
PSC
Primary Sclerosing Cholangitis
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases