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NCT02118012 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl in Patients With Chronic Hepatitis C
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02118012: Completed Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02118012 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02118012, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Background: \- Hepatitis C is a liver disease caused by the hepatitis C virus. It is the most common cause of serious liver disease in the United States. Many people have few if any symptoms. It can lead to cirrhosis, which can cause liver failure and cancer. Researchers want to study how a medicine called chlorcyclizine works in patients with hepatitis C. They want to see if it can be used to treat hepatitis C alone or when used with the standard hepatitis C treatment drug ribavirin. Objectives: \- To see if chlorcyclizine can be used to treat hepatitis C alone or in combination with the drug ribavirin. Eligibility: \- Adults with chronic hepatitis C who either have never been treated for it or have relapsed after prior treatment. Design: * Participants will be screened with medical history, physical exam, blood and urine tests, and a questionnaire. They will also have an ultrasound of their abdomen and electrocardiogram. Some of these tests will be repeated throughout the study. * Participants will spend 3 days as an inpatient to be monitored while starting study drug. They will be assigned randomly to a group and will begin taking the study drug. Blood will be taken frequently. * Group I will take the study drug twice a day for 28 days. * Group II will take the study drug twice a day and ribavirin twice a day for 28 days. * Participants will visit the clinic every 7 days for 28 days. * After participants stop taking the study drug, they will have 5 follow-up visits over 3 months.
Interventions
- DRUG Ribavirin
- DRUG Chlorcyclizine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-03-20 |
| Est. Completion | 2016-09-20 |
| Phase | Phase 1 |
What the finished NCT02118012 record still lists
NCT02118012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Ribavirin is the first listed.
NCT02118012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02118012 about?
NCT02118012 is a clinical study titled "Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl in Patients With Chronic Hepatitis C". Background: \- Hepatitis C is a liver disease caused by the hepatitis C virus. It is the most common cause of serious liver disease in the United States. Many people have few if any symptoms. It can lead to cirrhosis, which can cause liver failure and cancer. Researchers want to study how a medicin...
What is the current status of trial NCT02118012?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-03-20. Estimated completion is 2016-09-20.
What interventions are being tested in trial NCT02118012?
The interventions under investigation include: Ribavirin (DRUG), Chlorcyclizine HCl (DRUG).
Who is sponsoring clinical trial NCT02118012?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02118012's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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