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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03301506




Registration number
NCT03301506
Ethics application status
Date submitted
26/09/2017
Date registered
4/10/2017
Date last updated
26/11/2024

Titles & IDs
Public title
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Scientific title
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Secondary ID [1] 0 0
2020-005198-29
Secondary ID [2] 0 0
CB8025-31731-RE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Biliary Cirrhosis 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 5 mg Capsule
Treatment: Drugs - Seladelpar 10 mg Capsule

Experimental: Seladelpar 5 mg Capsules -

Experimental: Seladelpar 10 mg Capsule -


Treatment: Drugs: Seladelpar 5 mg Capsule
Subjects will be assigned to a treatment group if tolerability issues noted in the previous study.

Treatment: Drugs: Seladelpar 10 mg Capsule
Subjects will be assigned to a treatment group unless there are tolerability issues.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
Timepoint [1] 0 0
Through study completion, up to 60 Months
Secondary outcome [1] 0 0
Death
Timepoint [1] 0 0
60 Months
Secondary outcome [2] 0 0
Liver transplantation
Timepoint [2] 0 0
60 Months
Secondary outcome [3] 0 0
Change in MELD
Timepoint [3] 0 0
60 Months
Secondary outcome [4] 0 0
Ascites
Timepoint [4] 0 0
60 Months
Secondary outcome [5] 0 0
Hospitalization for variceal bleeding
Timepoint [5] 0 0
60 Months
Secondary outcome [6] 0 0
Hospitalization for hepatic encephalopathy
Timepoint [6] 0 0
60 Months
Secondary outcome [7] 0 0
Hospitalization for spontaneous bacterial peritonitis
Timepoint [7] 0 0
60 Months
Secondary outcome [8] 0 0
Response on composite endpoint
Timepoint [8] 0 0
60 Months
Secondary outcome [9] 0 0
Response on composite endpoint
Timepoint [9] 0 0
60 Months
Secondary outcome [10] 0 0
Normalization of ALP
Timepoint [10] 0 0
60 Months
Secondary outcome [11] 0 0
Laboratory Value: Serum Alkaline Phosphatase (ALP)
Timepoint [11] 0 0
Through study completion, up to 60 Months
Secondary outcome [12] 0 0
Laboratory Value: Aspartate Aminotransferase (AST)
Timepoint [12] 0 0
Through study completion, up to 60 Months
Secondary outcome [13] 0 0
Laboratory Value: Alanine Aminotransferase (ALT)
Timepoint [13] 0 0
Through study completion, up to 60 Months
Secondary outcome [14] 0 0
Laboratory Value: Gamma-glutamyl Transferase (GGT)
Timepoint [14] 0 0
Through study completion, up to 60 Months
Secondary outcome [15] 0 0
Laboratory Value: Bilirubin - Total Bilirubin
Timepoint [15] 0 0
Through study completion, up to 60 Months
Secondary outcome [16] 0 0
Laboratory Value: Bilirubin - Conjugated Bilirubin
Timepoint [16] 0 0
Through study completion, up to 60 Months
Secondary outcome [17] 0 0
Laboratory Value: Bilirubin - Unconjugated Bilirubin
Timepoint [17] 0 0
Through study completion, up to 60 Months

Eligibility
Key inclusion criteria
1. Must have given written informed consent (signed and dated)
2. Participated in a PBC study with seladelpar
3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are only applicable for subjects with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption.

1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer, any active infection)
3. AST or ALT above 3 × the upper limit of normal (ULN)
4. Total bilirubin above 2 × ULN
5. MELD score = 12. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
7. eGFR =45 mL/min/1.73 m2 (calculated by MDRD formula)
8. Auto-immune hepatitis
9. Primary sclerosing cholangitis
10. Known history of alpha-1-antitrypsin deficiency
11. Known history of chronic viral hepatitis
12. For females, pregnancy or breast-feeding
13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
14. Current use of fibrates or use of fibrates within 3 months prior to Screening
15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
17. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
19. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator
20. Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
21. Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis
22. Positive for:

1. Hepatitis B, defined as the presence of hepatitis B surface antigen
2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
3. Human immunodeficiency virus (HIV) antibody
23. Active COVID-19 infection during screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
12/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Balvanera
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
El Palomar
Country [25] 0 0
Argentina
State/province [25] 0 0
La Plata
Country [26] 0 0
Austria
State/province [26] 0 0
Wels
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Canada
State/province [29] 0 0
Calgary
Country [30] 0 0
Canada
State/province [30] 0 0
Toronto
Country [31] 0 0
Chile
State/province [31] 0 0
La Serena
Country [32] 0 0
Czechia
State/province [32] 0 0
Ostrava
Country [33] 0 0
France
State/province [33] 0 0
Lyon
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
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Germany
State/province [36] 0 0
Erlangen
Country [37] 0 0
Germany
State/province [37] 0 0
Hamburg
Country [38] 0 0
Germany
State/province [38] 0 0
Herne
Country [39] 0 0
Germany
State/province [39] 0 0
Kiel
Country [40] 0 0
Germany
State/province [40] 0 0
Tübingen
Country [41] 0 0
Greece
State/province [41] 0 0
Larisa
Country [42] 0 0
Hungary
State/province [42] 0 0
Budapest
Country [43] 0 0
Hungary
State/province [43] 0 0
Kaposvár
Country [44] 0 0
Israel
State/province [44] 0 0
Haifa
Country [45] 0 0
Israel
State/province [45] 0 0
Jerusalem
Country [46] 0 0
Israel
State/province [46] 0 0
Ramat Gan
Country [47] 0 0
Israel
State/province [47] 0 0
Tel Aviv
Country [48] 0 0
Israel
State/province [48] 0 0
Tel-Aviv
Country [49] 0 0
Italy
State/province [49] 0 0
Modena
Country [50] 0 0
Italy
State/province [50] 0 0
Palermo
Country [51] 0 0
Italy
State/province [51] 0 0
Rozzano
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Bucheon-Si
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Busan
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Daegu
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seongnam
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Songpa-Gu
Country [58] 0 0
Mexico
State/province [58] 0 0
Metepec
Country [59] 0 0
Mexico
State/province [59] 0 0
Roma Norte
Country [60] 0 0
Netherlands
State/province [60] 0 0
Nijmegen
Country [61] 0 0
New Zealand
State/province [61] 0 0
Christchurch
Country [62] 0 0
New Zealand
State/province [62] 0 0
Dunedin
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Poland
State/province [63] 0 0
Katowice
Country [64] 0 0
Poland
State/province [64] 0 0
Myslowice
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Romania
State/province [65] 0 0
Bucharest
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Russian Federation
State/province [66] 0 0
Saint Petersburg
Country [67] 0 0
Spain
State/province [67] 0 0
Badalona
Country [68] 0 0
Spain
State/province [68] 0 0
Barcelona
Country [69] 0 0
Spain
State/province [69] 0 0
Horcajo de la Sierra
Country [70] 0 0
Spain
State/province [70] 0 0
Madrid
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Spain
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Malaga
Country [72] 0 0
Spain
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Santander
Country [73] 0 0
Switzerland
State/province [73] 0 0
Zurich
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Turkey
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Ankara
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Turkey
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Bornova
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Turkey
State/province [76] 0 0
Cankaya
Country [77] 0 0
Turkey
State/province [77] 0 0
Maltepe
Country [78] 0 0
Turkey
State/province [78] 0 0
Topkapi
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Birmingham
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Hull
Country [81] 0 0
United Kingdom
State/province [81] 0 0
London
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Newcastle Upon Tyne
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Nottingham
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Plymouth
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Portsmouth

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

Ethics approval
Ethics application status

Summary
Brief summary
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Trial website
https://clinicaltrials.gov/study/NCT03301506
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03301506