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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

PHASE3RECRUITING

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC).

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Study details:

Primary:. To evaluate the long-term safety and tolerability of seladelpar. Secondary:.

* To evaluate the long-term efficacy of seladelpar. * To evaluate the effect of seladelpar on patient-reported outcomes (pruritus).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Must have given written informed consent (signed and dated)

Participated in a PBC study with seladelpar

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

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.

Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar

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)

AST or ALT above 3 × the upper limit of normal (ULN)

Total bilirubin above 2 × ULN

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.

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)

eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)

Auto-immune hepatitis

Primary sclerosing cholangitis

Known history of alpha-1-antitrypsin deficiency

Known history of chronic viral hepatitis

For females, pregnancy or breast-feeding

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

Current use of fibrates or use of fibrates within 3 months prior to Screening

Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening

Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening

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

Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening

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

Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)

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

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

Active COVID-19 infection during screening

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2017-12-12

Primary completion: 2028-11-01

Study completion finish: 2028-11-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT03301506

Intervention or treatment

DRUG: Seladelpar 5 mg Capsule

DRUG: Seladelpar 10 mg Capsule

Conditions

• Primary Biliary Cirrhosis

Image related to Primary Biliary Cirrhosis

Condition: Primary Biliary Cirrhosis
DRUG: Seladelpar 5 mg Capsule and other drugs
Herston, Queensland, Australia and more
Sponsor: Gilead Sciences

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Find a site

Closest Location:

Royal Brisbane and Women's Hospital

Research sites nearby

Select from list below to view details:

Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Seladelpar 5 mg Capsules Not Specified	DRUG: Seladelpar 5 mg Capsule Subjects will be assigned to a treatment group if tolerability issues noted in the previous study.
EXPERIMENTAL: Seladelpar 10 mg Capsule Not Specified	DRUG: Seladelpar 10 mg Capsule Subjects will be assigned to a treatment group unless there are tolerability issues.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results	Not Specified	Through study completion, up to 60 Months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Death	Occurrence of overall death	60 Months
Liver transplantation	Occurrence of overall liver transplantation	60 Months
Change in MELD	MELD score ≥ 15 for at least 2 consecutive visits	60 Months
Ascites	Occurrence of overall ascites requiring treatment	60 Months
Hospitalization for variceal bleeding	Hospitalization for new onset, or recurrence, of variceal bleeding	60 Months
Hospitalization for hepatic encephalopathy	Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)	60 Months
Hospitalization for spontaneous bacterial peritonitis	Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)	60 Months
Response on composite endpoint	Alkaline phosphate (ALP)	60 Months
Response on composite endpoint	Total bilirubin	60 Months
Normalization of ALP	Proportion of subjects with normalization of ALP	60 Months
Laboratory Value: Serum Alkaline Phosphatase (ALP)	Serum Alkaline Phosphatase (ALP)	Through study completion, up to 60 Months
Laboratory Value: Aspartate Aminotransferase (AST)	Aspartate Aminotransferase (AST)	Through study completion, up to 60 Months
Laboratory Value: Alanine Aminotransferase (ALT)	Alanine Aminotransferase (ALT)	Through study completion, up to 60 Months
Laboratory Value: Gamma-glutamyl Transferase (GGT)	Gamma-glutamyl Transferase (GGT)	Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Total Bilirubin	Bilirubin - Total Bilirubin	Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Conjugated Bilirubin	Bilirubin - Conjugated Bilirubin	Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Unconjugated Bilirubin	Bilirubin - Unconjugated Bilirubin	Through study completion, up to 60 Months

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)