Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl Alone or in Combination With Ribavirin in Patients With Chronic Hepatitis C
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|ClinicalTrials.gov Identifier: NCT02118012|
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : September 20, 2019
- 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.
- To see if chlorcyclizine can be used to treat hepatitis C alone or in combination with the drug ribavirin.
- Adults with chronic hepatitis C who either have never been treated for it or have relapsed after prior treatment.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Other: Chlorcyclizine HCL plus Ribavirin Other: Chlorcyclizine HCL Only||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl Alone or in Combination With Ribavirin in Patients With Chronic Hepatitis C|
|Study Start Date :||March 20, 2014|
|Actual Primary Completion Date :||March 20, 2014|
|Actual Study Completion Date :||September 20, 2016|
Active Comparator: Chlorcyclizine and RBV
Chlorcyclizine HCl and Ribavirin
Other: Chlorcyclizine HCL plus Ribavirin
RBV+ chlorcyclizine HCl (75 mg twice daily)
Active Comparator: Chlorcyclizine HCl only
chlorcyclizine HCl (75 mg twice daily)
Other: Chlorcyclizine HCL Only
chlorcyclizine HCl (75 mg twice daily)
- Decline in serum HCV RNA viral titer. [ Time Frame: 28 days ]Decline in HCV Viral Titer at the end of treatment (28 days).
- The ability to tolerate the drug at the prescribed dose for the duration of therapy. [ Time Frame: 28 days ]The ability to tolerate the drug at the prescribed dose for the duration of therapy.
- 1. A significant change in alanine aminotransferase (ALT) levels compared to baseline.2. Quantification of chlorcyclizine HCL and its metabolites in serum during therapy.3. Changes in symptom scale measurements during and after therapy. [ Time Frame: 28 days ]change in ALT measurements at the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118012
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Christopher Koh, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|