Understanding the progression of Noncirrhotic Portal Hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the natural history of Noncirrhotic Portal Hypertension (NCPH) by enrolling up to 400 participants aged 12 and older who have NCPH or are at risk for developing it. Participants will undergo a series of assessments including medical history, physical exams, imaging studies, and blood tests to gather data on the disease's progression and biological mechanisms. The study seeks to identify novel biomarkers and establish guidelines for monitoring and managing NCPH effectively.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Male or female, aged \>= 18 years of age, and minors 12-17 years of age.
* Women of childbearing potential must agree to use birth control unless they are menopausal or had hysterectomy.
* Known diagnosis of NCPH, or to be at the risk for NCPH by virtue of underlying disease processes such as but not limited to; CGD, SCD, Mastocytosis, CVID, CF, and CHF.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Pregnancy.
* Evidence of other forms of liver disease that typically result in cirrhosis.
* Evidence of active Chronic Hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) in serum and elevated HBV DNA (\>10,000 IU/mL).
* Hepatitis C as defined by the presence of hepatitis C RNA in serum.
* Evidence of other liver disease such as primary sclerosing cholangitis, primary biliary cirrhosis, Wilson s disease, autoimmune hepatitis as defined by either liver histology or laboratory abnormalities.
* Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy or homozygosity for C282Y. Patients with iron saturation indices of \>45% and serum ferritin levels of \>300 ng/ml for men and \>250 ng/ml for women will undergo genetic testing for hemochromatosis.
* Bile duct obstruction as suggested by imaging studies done within the previous six months.
* The presence of cirrhosis confirmed by liver biopsy.
* Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year (assessed during subject interviews by subject self-report).
* Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 50 ng/ml (normal \<6.6ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
* Evidence of cholangiocarcinoma as suggested by liver histology.
* Any other severe condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.
* Inability to comply or give written informed consent.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Theo Heller, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study coordinator: Jaha F Norman-Wheeler
• Email: jaha.norman-wheeler@nih.gov
• Phone: (301) 435-6122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.