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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06051617




Registration number
NCT06051617
Ethics application status
Date submitted
18/09/2023
Date registered
25/09/2023

Titles & IDs
Public title
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Scientific title
AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Secondary ID [1] 0 0
2024-516525-31-00
Secondary ID [2] 0 0
CB8025-41837
Universal Trial Number (UTN)
Trial acronym
AFFIRM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Biliary Cholangitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Seladelpar
Treatment: Drugs - Placebo

Experimental: Seladelpar -

Placebo comparator: Placebo -


Treatment: Drugs: Seladelpar
* Seladelpar 10 mg one capsule daily for up to 36 months in participants with CP-A cirrhosis or
* Seladelpar 5 mg one capsule daily for up to 36 months in participants with CP-B cirrhosis.

Treatment: Drugs: Placebo
One capsule daily for up to 36 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival (EFS)
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Liver transplant-free survival
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Time to hospitalization
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Time to Event Free Survival (EFS)
Timepoint [4] 0 0
36 months

Eligibility
Key inclusion criteria
Individuals must meet the following criteria to be eligible for study participation:

1. Must be at least 18 years old.
2. Must have a confirmed prior diagnosis of PBC
3. Evidence of cirrhosis
4. CP Score A or B
5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals must not meet any of the following criteria to be eligible for study participation:

1. Prior exposure to seladelpar
2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
4. Decompensated cirrhosis
5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
6. Hospitalization for liver-related complication within 12 weeks of Screening
7. Laboratory parameters at Screening:

1. Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or = 10×ULN
2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) =5×ULN
3. Total bilirubin (TB) =5×ULN
4. Platelet count =50×10^3/µL
5. Albumin =2.8 g/dL
6. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m^2
7. MELD score >12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
8. Serum alpha-fetoprotein (AFP) >20 ng/mL
9. INR >1.7
8. CP-C cirrhosis
9. History or presence of other concomitant liver diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2030
Actual
Sample size
Target
318
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Flinders Medical Center - Adelaide
Recruitment hospital [2] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Busan
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Daegu
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seongnam
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Turkey
State/province [24] 0 0
Adana
Country [25] 0 0
Turkey
State/province [25] 0 0
Ankara
Country [26] 0 0
Turkey
State/province [26] 0 0
Gaziantep
Country [27] 0 0
Turkey
State/province [27] 0 0
Gorukle
Country [28] 0 0
Turkey
State/province [28] 0 0
Izmir
Country [29] 0 0
Turkey
State/province [29] 0 0
Karabaglar
Country [30] 0 0
Turkey
State/province [30] 0 0
Kocaeli
Country [31] 0 0
Turkey
State/province [31] 0 0
Maltepe
Country [32] 0 0
Turkey
State/province [32] 0 0
Mersin
Country [33] 0 0
Turkey
State/province [33] 0 0
Pendik

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06051617