Open Clinical Trials Relevant to PSC

PSC-129615-edited.jpgDelaying Progression (Interventional Trials)

In the absence of a clear understanding of what causes Primary Sclerosing Cholangitis (PSC) and targeted therapies that address that cause(s), it is critically important to develop and test new therapies that delay the progression of PSC, buying patients more time with as much healthy, functional liver and bile duct tissue as possible.  Check out the trials below to learn what therapies are being tested to slow progression of PSC or to learn how to participate in one of these research studies.

Antifibrotics (Bile Ducts + Liver)

Immunomodulators

  • Induction of Regulatory T Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases (TRANSREG)  
  • A Trial of BTT1023 in Patients with Primary Sclerosing Cholangitis (BUTEO)  

Antibiotics/Probiotics

Bile Acid Modifiers

Autoimmune Sclerosing Cholangitis (ASC) and PSC/AIH Overlap

Studies open to PSC/AIH Overlap Patients

  • Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis 
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Images L to R by Joy Worthington, Roger Chapman [CC BY 2.0 (http://creativecommons.org/licenses/by/2.0)], via Wikimedia Commons;  By Orrling and Tomer S (Own work); By Nephron (Own work) [CC BY-SA 3.0 (http://creativecommons.org/licenses/by-sa/3.0) or GFDL (http://www.gnu.org/copyleft/fdl.html)], via Wikimedia Commons

Itch_02.jpgSymptom Management (Interventional Trials)

Anyone with PSC knows that beyond  the slow progression of the biliary disease that ultimately causes liver failure, the symptoms associated with liver and bile duct dysfunction are miserable.  Severe itching, known as pruritus, sleep disturbances, pain, and sometimes debilitating fatigue are leading symptoms associated with PSC.  Check out the trials below to learn what is being done to address these issues impacting quality of life in PSC or to learn how to participate in one of these research studies.

Pruritus

Natural History Studies and Observational Studies

In the absence of a clear understanding of what causes PSC, it is critically important to track PSC patients over time and study the underlying biology of this disease.  Check out the trials below to learn what studies are ongoing that may shed more light on the nature of PSC.

Diagnostic Development

Read here about trials focused on developing new ways to diagnose PSC and similar, related, or overlapping conditions, including cancers common in PSC.

Cholangiocarcinoma_-_intermed_mag.jpgCancer                       (Interventional Trials)

People with PSC are at increased risk of developing multiple types of cancer.  If you have been diagnosed with cancer in the setting of PSC, check out the trials below, which may be relevant to your situation, and discuss with your physician(s) as early as possible whether you should enroll in a clinical trial.  Some of these trials may not apply to your situation depending on the state of your autoimmune disease or if your liver function does not meet criteria for enrollment.  These listings are meant to inform discussions with your doctor.  If you are aware of a clinical trial for cancer that may be of relevance to patients with PSC that is not listed here, please contact us so we can include that information in this list.  Please contact us through this form if you have a cancer diagnosis in PSC and need help being connected with additional resources, or call us at +1 (412) 447-0900.

Cholangiocarcinoma (CCA)

  1. CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer  
  2. Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations  
  3. Recruitment Suspended: T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer  
  4. A Study of Patients Receiving High-Dose Rate Brachytherapy  
  5. Recruitment Suspended: A Phase I Study of Belinostat in Combination With Cisplatin and Etoposide in Adults With Small Cell Lung Carcinoma and Other Advanced Cancers  
  6. Recruitment Suspended: T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive  
  7. NCI-MPACT: Molecular Profiling-Based Assignment of Cancer Therapy for Patients With Advanced Solid Tumors  
  8. Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction 
  9. TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas 
  10. FdCyd and THU for Advanced Solid Tumors 
  11. AZD1775 for Advanced Solid Tumors
  12. Phase I Trial of 4'-Thio-2'-Deoxycytidine (TdCyd) in Patients With Advanced Solid Tumors
  13. Trial of the Combination of Bortezomib and Clofarabine in Adults With Relapsed Solid Tumors
  14. Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors

More CCA trials at clinicaltrials.gov   

  • Colorectal Cancer (CRC)

  • Coming Soon.
  • Hepatocellular Carcinoma (HCC)

  • Coming Soon.