Hepatitis C Clinical Trial
Official title:
The Effect of Omega-3 Fatty Acids (Omacor@) on the Response Rate to Antiviral Therapy in Patients With Chronic Hepatitis C Infection
Hepatitis C virus infection is the most common blood-borne infection in the United States
and is a leading cause of chronic liver disease affecting 130 million people around the
world. It is estimated that 1.6% of the US population may be affected by Hepatitis C
infection. The only recommended treatment that has been approved for your condition is the
use of interferon and ribavirin. In patients with chronic Hepatitis C, there tends to be an
accumulation of fat in the liver. Fatty liver has been associated with failure of treatment.
The accumulation of fat in the liver has been blamed on a particular type of fat called
triglycerides. Fish oil, by reducing a type of fat called VLDL, can lower the triglyceride
concentration by as much as 50 percent or more. This study seeks to determine if the
administration of fish oil along with standard treatment to patients with Hepatitis C will
increase the treatment response rates.
Hepatic steatosis may be present in up to 66% of cases of chronic Hepatitis C infection.
Previous studies have reported steatosis to be an independent predictor of treatment failure
in patients with chronic hepatitis C infection.
The pathogenesis of hepatic steatosis in chronic Hepatitis C infection has not been fully
elucidated. Hepatic steatosis is a manifestation of excessive triglyceride accumulation in
the liver. Hypertriglyceridemia may benefit from Omega-3 fatty acid (fish oil supplements)
which, by reducing VLDL production can lower the serum triglyceride concentration by as much
as 50 percent or more.
The treatment of chronic hepatitis C results in an average sustained viral response rate of
54%-63%. We have found response rates of around 50% on treatment of patients. We hypothesize
that by giving omega-3 fatty acids along with interferon therapy for patients with Hepatitis
C, we may be able to increase the treatment response rates. Thus, the purpose of the study
is to look at the effect of omega 3 fatty acids on early and sustained viral response rates
in patients with chronic HCV infection.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Recruiting |
NCT04510246 -
Link Hepatitis C Notifications to Treatment in Tasmania
|
N/A | |
| Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
| Completed |
NCT03109457 -
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
|
||
| Completed |
NCT03118674 -
Harvoni Treatment Porphyria Cutanea Tarda
|
Phase 2 | |
| Completed |
NCT01458054 -
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
|
Phase 1 | |
| Completed |
NCT03740230 -
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
|
||
| Completed |
NCT03426787 -
Helping Empower Liver and Kidney Patients
|
N/A | |
| Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
| Completed |
NCT00006301 -
Immune Response to Hepatitis C Virus
|
||
| Active, not recruiting |
NCT03949764 -
The Kentucky Viral Hepatitis Treatment Study
|
Phase 4 | |
| Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
| Recruiting |
NCT04405024 -
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
|
N/A | |
| Completed |
NCT04525690 -
Improving Inpatient Screening for Hepatitis C
|
N/A | |
| Completed |
NCT04033887 -
Evaluation Study of RDTs Detecting Antibodies Against HCV
|
||
| Withdrawn |
NCT04546802 -
HepATocellular Cancer Hcv Therapy Study
|
Phase 3 | |
| Active, not recruiting |
NCT02961426 -
Strategic Transformation of the Market of HCV Treatments
|
Phase 2/Phase 3 | |
| Completed |
NCT02992184 -
PoC-HCV Genedrive Viral Detection Assay Validation Study
|
N/A | |
| Completed |
NCT03186313 -
A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection
|
Phase 3 | |
| Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 |