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

March 2, 2023 updated by: Dae Won Jun, Hanyang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 133792
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of, 135720
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 134701
        • Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of, 130702
        • Kyong Hee University Medical Center
      • Seoul, Korea, Republic of, 140887
        • Sooncunhayng University Hospital Seoul
      • Seoul, Korea, Republic of, 156707
        • Boramae Medical Center
      • Seoul, Korea, Republic of, 156861
        • Chungang University Hospital
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, Korea, Republic of, 330721
        • SoonChunHyang University Hospital Cheonan
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 420767
        • Soonchunhyang University Hospital Bucheon
    • Gyeonggido
      • Guri, Gyeonggido, Korea, Republic of, 471701
        • Hanyang University Guri Hospital
      • Seongnam, Gyeonggido, Korea, Republic of, 463774
        • Bundang Jesaeng Hospital
    • Kangwondo
      • Chuncheon, Kangwondo, Korea, Republic of, 200704
        • Chuncheon Sacred Heart Hospital
      • Wonju, Kangwondo, Korea, Republic of, 220-701
        • Wonju Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic genotype 1-3 HCV infection
  • Treatment Naive

Exclusion Criteria:

  • Child B and C
  • HCC patients
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Peginterferon alfa 2a+Ribavirin
standard of care for HCV : peginterferon alfa 2a and ribavirin
Experimental: Vit D+Peginterferon alfa 2a+Ribavirin
VitD+Peginterferon alfa 2a+Ribavirin
Drug: Vit D
800IU/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Sustained virologic response (SVR)
Time Frame: 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.
24w after completing Peg/RBV

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with End of treatment response (ETR)
Time Frame: 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
48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3
Number of participants with Rapid virological response (RVR)
Time Frame: 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
Week 4
Number of participants with Early virological response (EVR)
Time Frame: 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
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Collaborators

Roche Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

January 20, 2018

Study Registration Dates

First Submitted

September 16, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (Estimate)

September 23, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25569

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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