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Natural History of Noncirrhotic Portal Hypertension

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Procedures mentioned: Ultrasound, Physical exams, Blood draws, MRI scans, Questionnaires, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: * Participants will have 2 screening visits. * Visit 1: to see if they have or may develop NCPH. * Medical history * Physical exam * Urine and stool studies * Abdominal ultrasound * Fibroscan."
  • "Sound waves measure liver stiffness. \<TAB\>- Visit 2: * Blood tests * Abdominal MRI * Echocardiogram * Questionnaire * Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement."
  • "This is done with a small tube inserted in a neck vein. * They may have a liver biopsy. * All participants will visit the clinic every 6 months for a history, physical exam, and blood tests."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people to learn how noncirrhotic portal hypertension (NCPH) develops over time. NCPH means high pressure in the liver’s blood vessels without cirrhosis (severe liver scarring). The study is for people age 12 and older who have NCPH or are at risk for it.

Background: \- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs. Many people may not even know that they have a liver disease. There are no specific treatments for NCPH. Objectives: \- To learn more about how NCPH develops over time. Eligibility: \- People age 12 and older who have NCPH or are at risk for getting it. In the past year, they cannot have had other types of liver disease that typically result in cirrhosis, liver cancer, or active substance abuse. Design: * Participants will have 2 screening visits. * Visit 1: to see if they have or may develop NCPH. * Medical history * Physical exam * Urine and stool studies * Abdominal ultrasound * Fibroscan. Sound waves measure liver stiffness. \<TAB\>- Visit 2: * Blood tests * Abdominal MRI * Echocardiogram * Questionnaire * Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This is done with a small tube inserted in a neck vein. * They may have a liver biopsy. * All participants will visit the clinic every 6 months for a history, physical exam, and blood tests. They will also repeat some of the screening tests yearly. * Participants with NCPH will also have: * Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and stomach. * At least every 2 years: Esophagogastroduodenoscopy. * At least every 4 years: testing including HVPG measurements and liver biopsy. * Participants without NCPH will also have: * Liver biopsy and HVPG measurements to see if they have NCPH. * Every 2 years: abdominal MRI and stool studies. * The study will last indefinitely.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 12 or older.
  • Have NCPH or a health condition that puts you at risk for it.
  • If you can become pregnant, agree to use birth control.

Who can't join

  • Being pregnant.
  • Having another liver disease that usually causes severe liver scarring, or having severe scarring confirmed by a liver tissue test.
  • Having active long-term hepatitis B or hepatitis C, which are viruses that infect the liver.
  • Having certain other liver diseases, including immune system diseases, Wilson’s disease (copper buildup), or hemochromatosis (iron buildup).
  • Having a blocked bile duct shown on a scan within the past 6 months. Bile ducts carry digestive fluid from the liver.
  • Having signs of liver cancer or bile duct cancer.
  • Having active alcohol or drug abuse within the past year.
  • Having another serious condition that prevents taking part, being unable to follow study requirements, or being unable to give written consent.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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.

Study sites (1)

MD