Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Hepatitis C and Cirrhosis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression. The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray.
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 |
What the finished NCT01888900 record still lists
NCT01888900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01888900's enrollment target sits among peer trials
35 81st of 106 higher than 26 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
ACTIVE NOT RECRUITING · Phase 2
-
Expanding the Pool in Orthotopic Heart Transplantation
ACTIVE NOT RECRUITING · Phase 2
-
The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
COMPLETED · Phase 2
-
Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C
COMPLETED · Phase 2
-
A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
COMPLETED · Phase 2
-
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01697371 · 35 participants · NA
Proton Therapy in the Treatment of Liver Metastases
- NCT01940757 · 35 participants · Phase 1
Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
- NCT02235857 · 35 participants · NA
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
- NCT02637934 · 35 participants · Phase 1
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia