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NCT02349048 · ClinicalTrials.gov registry record · Phase 2
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
A Phase 2 study of Hepatitis C Virus, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 8
- Study locations
NCT02349048 is a Phase 2 study of Hepatitis C Virus that has completed, run by Janssen Research & Development. The registered enrollment target is 68 participants, below the 295-participant average among 3 other Hepatitis C Virus trials with a reported enrollment target (77% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT02349048, a Phase 2 study of Hepatitis C Virus, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or investigational drug) participants with chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early stages of liver fibrosis or with cirrhosis.
Conditions Studied
Interventions
- DRUG Simeprevir 150 mg
- DRUG Daclatasvir 60 mg
- DRUG Sofosbuvir 400 mg
Study Locations (8)
Texas
- - Arlington
- - San Antonio
California
- - Bakersfield
Florida
- - Jacksonville
Maryland
- - Lutherville
North Carolina
- - Winston-Salem
Tennessee
- - Knoxville
Ontario
- - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02349048
The ClinicalTrials.gov registry entry for NCT02349048 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 295-participant average among 3 other Hepatitis C Virus trials with a reported enrollment target (77% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis C Virus appearing as the primary indexed condition, and to 3 interventions - of which Simeprevir 150 mg is the first listed.
NCT02349048 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT02349048 about?
NCT02349048 is a clinical study titled "Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection". The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or investigational drug) participants with chronic hepatitis (inflammatio...
What is the current status of trial NCT02349048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2015-01. Estimated completion is 2016-05.
What conditions does trial NCT02349048 study?
This clinical trial studies the following conditions: Hepatitis C Virus.
What interventions are being tested in trial NCT02349048?
The interventions under investigation include: Simeprevir 150 mg (DRUG), Daclatasvir 60 mg (DRUG), Sofosbuvir 400 mg (DRUG).
Who is sponsoring clinical trial NCT02349048?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02349048 being conducted?
This trial has 8 study locations across California, Florida, Maryland, North Carolina, Tennessee. 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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