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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vit D
Sponsored by
Hanyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring chronic hepatitis C, SVR, Vit D, Peginterferon alfa 2a, Ribavirin

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic genotype 1-3 HCV infection
  • Treatment Naive

Exclusion Criteria:

  • Child B and C
  • HCC patients
  • Pregnancy

Sites / Locations

  • Soonchunhyang university Hospital Cheonan
  • Soonchunhyang university hospital Bucheon
  • HANYANG University Guri Hospital
  • Bundang Jesaeng Hospital
  • Chuncheon Sacred Heart Hospital
  • Wonju Christian Hospital
  • Kyong Hee University Medical Center
  • Hanyang University Seoul Hospital
  • Kangdong Sacred Heart Hospital
  • Gangnam Severance Hospital
  • Sooncunhayng University Hospital Seoul
  • BORAMAE Medical Center
  • Chungang University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Peginterferon alfa 2a+Ribavirin

Vit D+Peginterferon alfa 2a+Ribavirin

Arm Description

standard of care for HCV : peginterferon alfa 2a and ribavirin

VitD+Peginterferon alfa 2a+Ribavirin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
September 16, 2011
Last Updated
March 2, 2023
Sponsor
Hanyang University
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT01439776
Brief Title
Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
January 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
chronic hepatitis C, SVR, Vit D, Peginterferon alfa 2a, Ribavirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Control: Peg-ING + ribavirin Treatment: peg-INF+ ribavirin + Vitamin D
Masking
None (Open Label)
Masking Description
Vitamin D add
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peginterferon alfa 2a+Ribavirin
Arm Type
No Intervention
Arm Description
standard of care for HCV : peginterferon alfa 2a and ribavirin
Arm Title
Vit D+Peginterferon alfa 2a+Ribavirin
Arm Type
Experimental
Arm Description
VitD+Peginterferon alfa 2a+Ribavirin
Intervention Type
Drug
Intervention Name(s)
Vit D
Intervention Description
800IU/day
Primary Outcome Measure Information:
Title
Number of participants with Sustained virologic response (SVR)
Description
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
Secondary Outcome Measure Information:
Title
Number of participants with End of treatment response (ETR)
Description
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
Title
Number of participants with Rapid virological response (RVR)
Description
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
Title
Number of participants with Early virological response (EVR)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic genotype 1-3 HCV infection Treatment Naive Exclusion Criteria: Child B and C HCC patients Pregnancy
Facility Information:
Facility Name
Soonchunhyang university Hospital Cheonan
City
Cheonan
State/Province
Chungcheongnam-do
ZIP/Postal Code
330721
Country
Korea, Republic of
Facility Name
Soonchunhyang university hospital Bucheon
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
420767
Country
Korea, Republic of
Facility Name
HANYANG University Guri Hospital
City
Guri
State/Province
Gyeonggido
ZIP/Postal Code
471701
Country
Korea, Republic of
Facility Name
Bundang Jesaeng Hospital
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
463774
Country
Korea, Republic of
Facility Name
Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Kangwondo
ZIP/Postal Code
200704
Country
Korea, Republic of
Facility Name
Wonju Christian Hospital
City
Wonju
State/Province
Kangwondo
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Kyong Hee University Medical Center
City
Seoul
ZIP/Postal Code
130702
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
133792
Country
Korea, Republic of
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
134701
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135720
Country
Korea, Republic of
Facility Name
Sooncunhayng University Hospital Seoul
City
Seoul
ZIP/Postal Code
140887
Country
Korea, Republic of
Facility Name
BORAMAE Medical Center
City
Seoul
ZIP/Postal Code
156707
Country
Korea, Republic of
Facility Name
Chungang University Hospital
City
Seoul
ZIP/Postal Code
156861
Country
Korea, Republic of

12. IPD Sharing Statement

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

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