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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
Harvard University |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01091077 |
Purpose
Hepatitis C virus when it leaves the cells in the liver is bound to a type of fat. An component of grapefruit could block this fat and thus lower the amount of virus in the blood stream. We propose that treatment with this ingredient, called naringenin, could be used to block this fat and HCV in persons infected with hepatitis C.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Virus HCV Infection Chronic HCV Hepatitis C |
Dietary Supplement: Naringenin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of the Grapefruit Flavonoid Naringenin for the Treatment of HCV Infection |
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Naringenin
Single dose of naringenin, compared to placebo in the same individual.
|
Dietary Supplement: Naringenin
1 gram of naringenin mixed with 16 grams of hydroxypropyl-β-cyclodextrin in 250 mL of water
Other Name: Grapefruit
|
The hepatitis C virus is actively secreted by the liver of infected patients while bound to very low density lipoprotein (vLDL). The grapefruit flavonoid naringenin could be used to block vLDL secretion and lower the circulating viral titer.
Hypothesis:
Treatment with naringenin will block vLDL and HCV secretion in persons infected with HCV.
Primary Objective
To study the safety and pharmacokinetics of a single-dose of naringenin
Secondary Objectives
This is a single-arm, cross over study where placebo is administered during a transition from a fasted to a fed state, then the protocol is repeated with a single dose of naringenin plus cyclodextrin, using the previous measurements as his/her own control
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with a history of clinically significant cardiac disease, including a family history of Long QT Syndrome, and/or evidence of the following ECG abnormalities at screening:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Arthur Y Kim, M.D. | Massachusetts General Hospital |
More Information
| Responsible Party: | Arthur Kim, M.D., Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01091077 History of Changes |
| Other Study ID Numbers: | GFN-001 |
| Study First Received: | March 17, 2010 |
| Last Updated: | June 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
dietary supplement |
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Naringenin Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |