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Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl in Patients With Chronic Hepatitis C

NCT02118012 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-06-09

Study results available
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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.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Chlorcyclizine HCl

Chlorcyclizine HCl (75 mg twice daily)

DRUG

Ribavirin

RBV was dosed via a weight-based regimen of 1000 mg daily\<75 kg and 1200 mg daily ≥75 kg.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Christopher Koh, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-20
Primary Completion
2014-03-20
Completion
2016-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02118012 on ClinicalTrials.gov