Open Clinical Trials

Primary biliary cholangitis (PBC) is an autoimmune liver disease that is treated with Ursodeoxycholic acid. Seladelpar is a PPAR delta agonist that has been shown to be effective in normalizing alk phos in those who fail to respond to Ursodiol. This trial will assess the effectiveness of seladelpar.

Subjects must meet the following criteria to be eligible for study participation:

18 to 75 years old (inclusive)

Male or female with a diagnosis of PBC based on history

UDCA for the 12 months prior to screening (with stable dose for >3 months prior to screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to screening)

ALP >1√óULN and <1.67√óULN

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 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.

Study Coordinator:
Vyvian Ngo
650-498-9125 
vyviann@stanford.edu

PI: Dr Aparna Goel: goela21@stanford.edu

Metabolic dysfunction-associated steatotic liver disease is the most common liver disease worldwide. Present in approximately 25% of the United States population, these individuals are at risk for progressive liver disease and the development of metabolic dysfunction-associated steatohepatitis (MASH) that can lead to progressive fibrosis and cirrhosis.   This trial is evaluating a novel glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) agonist, Pemvidutide in the treatment of those with MASH and stage 2-3 fibrosis on liver biopsy.

Inclusion criteria

1.     Written informed consent

1. Male or female 18-75 years

3.     Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening

1. Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment
2. BMI ≥ 27.0 kg/m2
3. Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening
4. The following GLP-1RAs are allowed provided that therapy is well-tolerated with absent or mild GI symptoms (nausea, vomiting, diarrhea, constipation, or abdominal pain):
5.  
   1. A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis [0-3], lobular inflammation [0-3], and hepatocyte ballooning [0-2])
   2. NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation

i. Liraglutide, dulaglutide, exenatide at any dose

ii. Semaglutide up to 1 mg weekly SC or 14 mg daily orally,

8.     Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005)

9.     Liver fat content by MRI-PDFF ≥ 8%

Study Coordinator:  
Jennifer Smart 
650-721-8517 
jsmart2@stanford.edu

PI: Dr Paul Kwo: pkwo@stanford.edu

The impact of medications used to treat IBD on male fertility remains poorly characterized, particularly for the advanced immunologic medications that have emerged over the past twenty years. The primary aim of this study is to evaluate whether advanced immunologic therapies used in inflammatory bowel disease (IBD) can impact male fertility as measured by semen analysis:

Inclusion criteria:

                -Adult men of age 18-50

                -Established diagnosis of IBD

Exclusion criteria

                            -Prior diagnosis of infertility or hypogonadism

                            -Concomitant usage of sulfasalazine, methotrexate, or cyclosporine

                            -Concomitant usage of testosterone supplementation

                            -Unable or unwilling to provide semen sample

                            -History of a vasectomy

                            -History of testicular surgery/trauma (cryptorchidism, testicular torsion, etc.)

                            -History of prior cancer therapy

                            - Unable or unwilling to consent

Study Coordinator: 
Brianna Cavalla:  
650-724-1084
cavallab@stanford.edu 
 

PI: Dr Sarah Streett: sstreett@stanford.edu

Dr. Afrin Kamal and Dr. Jason Wang, Stanford University Faculty, are conducting a new qualitative study in public health to address health promotion and prevention issues. We aim to help researchers develop a mobile health application for acid reflux by answering the following questions: how has GERD impacted the lives of affected individuals, what are the needs of those affected by GERD, what features are these individuals interested in, and what barriers do patients experience for medication adherence? Participants with chronic GERD symptoms, 18 years of age or older, have confirmed diagnosis of reflux by testing and can speak English, may share personal experiences and everyday challenges with acid reflux through a semi-structured interview with the study team. In return for their valuable insights, participants will receive a $50.00 gift card. If your patients fit these requirements and are interested in participating in a research study, please direct them to KnowReflux.org for more information or to sign up.

Study Coordinator:
Caroline Antonov
650-723-7479
Cantonov@stanford.edu


PI: Dr Afrin Kamal: kamala@stanford.edu