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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Hanyang University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Dae Won Jun, Hanyang University
ClinicalTrials.gov Identifier:
NCT01439776
First received: September 16, 2011
Last updated: September 22, 2011
Last verified: September 2011

September 16, 2011
September 22, 2011
September 2011
February 2013   (final data collection date for primary outcome measure)
Number of participants with Sustained virologic response (SVR) [ Time Frame: 24w after completing Peg/RBV ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01439776 on ClinicalTrials.gov Archive Site
  • Number of participants with End of treatment response (ETR) [ Time Frame: 48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Compare the number of participants with HCV RNA cannot be detected in the blood at week 12 of treatment between viatmin and control group
Same as current
Not Provided
Not Provided
 
Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
Dietary Supplement: Vit D
800IU/day
Other Name: Vit D
  • 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
    Intervention: Dietary Supplement: Vit D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
222
August 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic genotype 1-3 HCV infection
  • Treatment Naive

Exclusion Criteria:

  • Child B and C
  • HCC patients
  • Pregnancy
Both
20 Years to 75 Years
No
Contact: Daewon Jun, professor 82222909501 noshin@hanyang.ac.kr
Contact: Jungmin Cho, CRC 82222909501 01sin03@naver.com
Korea, Republic of
 
NCT01439776
ML25569
No
Dae Won Jun, Hanyang University
Hanyang University
Roche Pharma AG
Not Provided
Hanyang University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP