Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients

Phase 4

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Vit D

• Registration Number: NCT01439776
• Lead Sponsor: Hanyang University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Primary Completion: 2017-12-15
• Study Completion: 2018-01-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Chronic genotype 1-3 HCV infection
• Treatment Naive

Exclusion Criteria

• Child B and C
• HCC patients
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vit D+Peginterferon alfa 2a+Ribavirin	Vit D	VitD+Peginterferon alfa 2a+Ribavirin

Primary Outcome Measures

Name	Time	Method
Number of participants with Sustained virologic response (SVR)	24w after completing Peg/RBV	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with Rapid virological response (RVR)	Week 4	Compare the number of participants with HCV RNA is notdetectable in the blood at week 4 of treatment between vitamin and control group
Number of participants with End of treatment response (ETR)	48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3	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
Number of participants with Early virological response (EVR)	Week 12	Compare the number of participants with HCV RNA cannot be detected in the blood at week 12 of treatment between viatmin and control group

Trial Locations

Locations (13)

HANYANG University Guri Hospital; 🇰🇷 Guri, Gyeonggido, Korea, Republic of

BORAMAE Medical Center; 🇰🇷 Seoul, Korea, Republic of

Sooncunhayng University Hospital Seoul; 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang university Hospital Cheonan; 🇰🇷 Cheonan, Chungcheongnam-do, Korea, Republic of

Bundang Jesaeng Hospital; 🇰🇷 Seongnam, Gyeonggido, Korea, Republic of

Soonchunhyang university hospital Bucheon; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of

Wonju Christian Hospital; 🇰🇷 Wonju, Kangwondo, Korea, Republic of

Kangdong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyong Hee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chungang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Kangwondo, Korea, Republic of