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NCT02417740 · ClinicalTrials.gov registry record
Natural History of Noncirrhotic Portal Hypertension
A clinical trial of Cystic Fibrosis and Turner Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- 400
- Enrollment target
- 1
- Study location
NCT02417740 is a study of Cystic Fibrosis and Turner Syndrome that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 400 participants, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (126% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02417740, a study of Cystic Fibrosis and Turner Syndrome, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2015-07-27 |
| Est. Completion | 2029-09-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02417740
The ClinicalTrials.gov registry entry for NCT02417740 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (126% higher). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.
NCT02417740 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02417740 about?
NCT02417740 is a clinical study titled "Natural History of Noncirrhotic Portal Hypertension". 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 N...
What is the current status of trial NCT02417740?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2015-07-27. Estimated completion is 2029-09-04.
What conditions does trial NCT02417740 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Turner Syndrome, Congenital Hepatic Fibrosis, Immunologic Deficiency Syndrome, Idiopathic Non-Cirrhotic Portal Hypertension.
Who is sponsoring clinical trial NCT02417740?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02417740 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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