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OpenTrials
Completed

NCT Number: NCT01439776

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soonchunhyang university Hospital Cheonan, Cheonan, Chungcheongnam-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic genotype 1-3 HCV infection
  • Treatment Naive

Exclusion criteria

  • Child B and C
  • HCC patients
  • Pregnancy

Treatment and study plan

Vit D

Drug

800IU/day

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study 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

Acronym: Addwin

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Sep 23, 2011
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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