NCT02417740Recruiting
Natural History of Noncirrhotic Portal Hypertension
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 15 Apr 2015
- Start date
- 27 Jul 2015
- Primary completion date
- 4 Sept 2029
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Diseases
- Cystic fibrosis, High blood pressure
- NCT number
- NCT02417740
What you commit to
- Study type: Observational
- Planned participants: 400
- From 27 Jul 2015 to the primary completion date, 4 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Bile duct obstruction as suggested by imaging studies done within the previous six months.
- Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year (assessed during subject interviews by subject self-report).
Other illness
- Evidence of other forms of liver disease that typically result in cirrhosis.
- 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.
- Any other severe condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.
Lab values
- 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.
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy.
- The presence of cirrhosis confirmed by liver biopsy.
- Evidence of cholangiocarcinoma as suggested by liver histology.
- Inability to comply or give written informed consent.
Criteria the registry did not label
- 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.
Age in the registry: 12 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.