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NCT00718172 · ClinicalTrials.gov registry record · Phase 1
Viral Kinetics and Liver Gene Expression in Response to Ribavirin and Peginterferon Therapy of Chronic Hepatitis C
A Phase 1 study of Hepatitis C, Chronic, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT00718172 is a Phase 1 study of Hepatitis C, Chronic that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 81 participants, below the 373-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00718172, a Phase 1 study of Hepatitis C, Chronic, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
Up to 120 patients with chronic hepatitis C will be enrolled in a study of viral kinetics and liver gene expression before and during combination therapy with peginterferon and ribavirin. Adult patients with chronic hepatitis C virus (HCV) infection who have compensated liver disease and have not received interferon in the past will be randomized into one of four groups. Groups A and C will undergo liver biopsy before starting peginterferon therapy and Groups B and D will undergo biopsy 6 hours after the initial dose of peginterferon. Furthermore, Groups C and D will receive a run-in period of 4 weeks of ribavirin therapy before starting peginterferon. All patients will receive the standard recommended doses of peginterferon alfa 2a (180 mcg sc weekly) and ribavirin (1000 or 1200 mg daily for genotypes 1, 4-6 and 800 mg daily for genotype 2 and 3) for up to 48 weeks (24 weeks for genotype 2 and 3). All patients in Groups C and D, irrespective of genotype, will be pretreated with ribavirin at a dose of 1000 or 1200 mg, depending on patient body-weight. After the initial peginterferon injection, patients will have blood taken and symptoms recorded at 6, 24, 48, 72 hours and weekly thereafter for four weeks to assess viral kinetic response. Liver biopsy tissue taken before or 6 hours after the initial dose of peginterferon will be assessed by standard light microscopy and also subjected to RNA extraction and microarray analysis of mRNA expression. Patients will be monitored carefully during therapy and tested regularly for HCV RNA levels. Therapy will be given for 48 weeks, but will be discontinued early for patients with genotype 1 infection if HCV RNA levels do not decline by at least 2 log IU/ml by week 12 (lack of an early virological response) or do not decline to undetectable levels by week 24 (lack of HCV RNA clearance). Patients with other genotypes with be treated for a full course of therapy regardless of early responses. After completing therapy, patients wi
Conditions Studied
Interventions
- PROCEDURE Liver Biopsy
- DRUG Peginterferon & Ribavirin for Hepatitis C
- DRUG Pre-treatment Ribavirin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2008-07-11 |
| Est. Completion | 2014-08-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00718172
The ClinicalTrials.gov registry entry for NCT00718172 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 373-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (78% 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 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 3 interventions - of which Liver Biopsy is the first listed.
NCT00718172 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00718172 about?
NCT00718172 is a clinical study titled "Viral Kinetics and Liver Gene Expression in Response to Ribavirin and Peginterferon Therapy of Chronic Hepatitis C". Up to 120 patients with chronic hepatitis C will be enrolled in a study of viral kinetics and liver gene expression before and during combination therapy with peginterferon and ribavirin. Adult patients with chronic hepatitis C virus (HCV) infection who have compensated liver disease and have not re...
What is the current status of trial NCT00718172?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2008-07-11. Estimated completion is 2014-08-19.
What conditions does trial NCT00718172 study?
This clinical trial studies the following conditions: Hepatitis C, Chronic.
What interventions are being tested in trial NCT00718172?
The interventions under investigation include: Liver Biopsy (PROCEDURE), Peginterferon & Ribavirin for Hepatitis C (DRUG), Pre-treatment Ribavirin (DRUG).
Who is sponsoring clinical trial NCT00718172?
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 NCT00718172 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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