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

Chronic Hepatitis C Clinical Trial

— Addwin  

Official title:

A Randomized, Multi-center, Phase IV Open-label Study Evaluating the Antiviral Efficacy of Addition of Vitamin D in Patients With Treatment Naïve Chronic Hepatitis C Receiving Peginterferon Alfa-2a Plus Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439776
• Other study ID #: ML25569
• Status: Completed
• Phase: Phase 4
• Start date: September 2011
• Est. completion date: January 20, 2018

Study information

• Verified date: March 2023
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 20, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Chronic genotype 1-3 HCV infection
• Treatment Naive

Exclusion Criteria:

• Child B and C
• HCC patients
• Pregnancy

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Vit D
800IU/day

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang university hospital Bucheon	Bucheon	Gyeonggi-do
Korea, Republic of	Soonchunhyang university Hospital Cheonan	Cheonan	Chungcheongnam-do
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon	Kangwondo
Korea, Republic of	HANYANG University Guri Hospital	Guri	Gyeonggido
Korea, Republic of	Bundang Jesaeng Hospital	Seongnam	Gyeonggido
Korea, Republic of	BORAMAE Medical Center	Seoul
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Kyong Hee University Medical Center	Seoul
Korea, Republic of	Sooncunhayng University Hospital Seoul	Seoul
Korea, Republic of	Wonju Christian Hospital	Wonju	Kangwondo

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University	Roche Pharma AG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24w after completing Peg/RBV
Secondary	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	48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3
Secondary	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	Week 4
Secondary	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	Week 12