IBAT Inhibitor A4250 for Cholestatic Pruritus

NCT02360852 | Terminated Phase 2

• 1 other identifier: A4250 PBC Pruritus
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety, tolerability and influence on itching, bile acids and liver enzyme changes in patients with PBC (Primary Biliary Cirrhosis) treated with A4250

Conditions

Biliary Cirrhosis, Primary

Outcome Measures

Primary Outcomes (1)

• •Safety and Tolerability assessed by the occurrence of treatment-emergent SAEs during the four weeks of treatment with A4250

  4 weeks

Secondary Outcomes (5)

• Safety laboratory measurements

  4 weeks

• VAS-Itch

  4 weeks

• Itching scale

  Four weeks

• Bile acid evaluation

  Four weeks

• Liver biochemistry

  Four weeks

Study Arms (1)

A4250

EXPERIMENTAL

A4250 once daily

Drug: A4250

Interventions

A4250 DRUG

A4250 once daily

Also known as: IBAT Inhibitor A4250

A4250

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PBC or PBC-Autoimmune hepatitis overlap as established according to American Association for the Study of Liver Diseases/European Association for the Study of Liver (AASLD/EASL) definitions. Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:
• History of elevated alkaline phosphatase (ALP) levels (\>1.67 ULN) for at least 6 months prior to Day 1
• Positive antimitochondrial antibodies (AMA) titer or if AMA negative or in low titer (\<1:80) PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components (PDC-E2, 2-oxo-glutaric acid dehydrogenase complex)
• Liver biopsy consistent with PBC;
• Ursodeoxycholic acid (UDCA) non-responders defined as \>6 months of UDCA and at the time of enrolment a serum ALP \>1.67 ULN;
• Laboratory markers of cholestasis identified within 3 months of Visit 1;
• Treatment with cholestyramine at a dose \>4g BID or colestipol \> 5mg for at least 3 months;
• The patient has a VAS-Itch of at least 30 mm during the day before baseline (Visit 2);
• The patient is a male or non-pregnant female ≥18 years of age and ≤80 years of age with body mass index (BMI) ≥18.5 but \<35 kg/m2;

You may not qualify if:

• Any condition that, in the opinion of the Investigator constitutes a risk for the patient or a contraindication for participation and completion of the study, or could interfere with study objectives, conduct, or evaluations;
• Jaundice of extrahepatic origin;
• The patient has a structural abnormality of the GI tract;
• The patient has a known, active, clinically significant acute or chronic infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti infectives within 4 weeks of treatment start (study day 1) or completion of oral anti-infective treatment within 2 weeks prior to start of screening period;
• The patient has unexplained and clinically significant GI alarm signals (e.g., lower GI bleeding or heme-positive stool, iron-deficiency anaemia, unexplained weight loss) or systemic signs of infection or colitis;

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Albireo: collaborator

Study Sites (1)

Sahlgrenska Academy

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanns-Ulrich Marschall, MD

  Sahlgrenska Academy, Institute of Medicine,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: February 11, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)