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NCT01888900 · ClinicalTrials.gov registry record · Phase 2
New Treatment Response in People With and Without Cirrhosis From Chronic Hepatitis C
A Phase 2 study of Hepatitis C and Cirrhosis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT01888900 is a Phase 2 study of Hepatitis C and Cirrhosis that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 35 participants, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01888900, a Phase 2 study of Hepatitis C and Cirrhosis, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Some people who have chronic hepatitis C do not respond to the usual treatment with peginterferon and ribavirin. New chronic hepatitis treatments are being developed that may work better for different people. The treatments will look at how specific genes interact with the drugs. Researchers want to see how well these new drugs work in people whose chronic hepatitis C has not responded or only partly responded to the usual treatment drugs. Objectives: \- To compare new treatments for people with chronic hepatitis C. Eligibility: \- Individuals at least 18 years of age who have chronic hepatitis C that has not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Liver scans and a biopsy will be taken before the start of treatment. * Participants will be separated into two groups. One group will have the new treatment drugs (assunaprevir and daclatasvir). The second group will have these two drugs as well as peginterferon and ribavirin. All participants will have an initial 4-day hospital stay with regular blood tests to see how the start of the treatment works. * The first group will take the new study drug tablets daily for 24 weeks. Those who do not respond to this treatment will also start to take peginterferon and ribavirin, and the treatment will continue for 24 weeks after starting the additional drugs. * The second group will take all four drugs according to the standard dosing schedule for 24 weeks. * Treatment will be monitored with frequent blood tests. Liver scans, biopsies, and other tests will be performed as directed by the study doctors. * Participants will have 24 weeks of regular followup visits.
Conditions Studied
Interventions
- DRUG DUAL
- DRUG QUAD
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01888900
The ClinicalTrials.gov registry entry for NCT01888900 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower). 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 4 conditions, with Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which DUAL is the first listed.
NCT01888900 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01888900 about?
NCT01888900 is a clinical study titled "New Treatment Response in People With and Without Cirrhosis From Chronic Hepatitis C". Background: \- Some people who have chronic hepatitis C do not respond to the usual treatment with peginterferon and ribavirin. New chronic hepatitis treatments are being developed that may work better for different people. The treatments will look at how specific genes interact with the drugs. Res...
What is the current status of trial NCT01888900?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2013-05. Estimated completion is 2015-11.
What conditions does trial NCT01888900 study?
This clinical trial studies the following conditions: Hepatitis C, Cirrhosis, Hepatitis C, Chronic, Chronic Hepatitis C.
What interventions are being tested in trial NCT01888900?
The interventions under investigation include: DUAL (DRUG), QUAD (DRUG).
Who is sponsoring clinical trial NCT01888900?
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 NCT01888900 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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