We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Dae Won Jun, Hanyang University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01439776
First Posted: September 23, 2011
Last Update Posted: September 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Dae Won Jun, Hanyang University
September 16, 2011
September 23, 2011
September 23, 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 ]
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
No Changes Posted
  • 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

  • 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
  • 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
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Hepatitis C
Dietary Supplement: Vit D
800IU/day
  • 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.
 
Unknown status
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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01439776
ML25569
No
Not Provided
Not Provided
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
To Top