A Phase 4 interventional study of Vit D in Chronic Hepatitis C, sponsored by Hanyang University. Completed at 13 sites in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-06.
Sponsored by Hanyang University · Phase 4, Interventional, and Treatment
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral response(SVR)compared to Peg/RBV.
The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR additionally.
950 studies on the registry are indexed under Hepatitis C, Chronic; 8 are open to participants now.
This study's enrollment of 180 is above the median of 90 across 696 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →Hanyang University is the lead sponsor of 52 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard of care for HCV : peginterferon alfa 2a and ribavirin
VitD+Peginterferon alfa 2a+Ribavirin
Drug: Vit D
800IU/day
Number of participants with Sustained virologic response (SVR)
Compare the number of participants with HCV RNA is not detected in the blood at 24 weeks post-treatment between vitamin D and control group.
Time frame: 24w after completing Peg/RBV
Number of participants with End of treatment response (ETR)
Compare the number of participants with HCV RNA is not detected in the blood at the end of treatment between two groups. HCV RNA pCR perform at 48 weeks in genotye 1, at 24 weeks in Genotye 2 and 3
Time frame: 48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3
Number of participants with Rapid virological response (RVR)
Compare the number of participants with HCV RNA is notdetectable in the blood at week 4 of treatment between vitamin and control group
Time frame: Week 4
Number of participants with Early virological response (EVR)
Compare the number of participants with HCV RNA cannot be detected in the blood at week 12 of treatment between viatmin and control group
Time frame: Week 12
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin D
Hanyang University