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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 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
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis C
Dietary Supplement: Vit D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hanyang University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 222
Study Start Date: September 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dietary Supplement: Vit D
800IU/day

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.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic genotype 1-3 HCV infection
  • Treatment Naive

Exclusion Criteria:

  • Child B and C
  • HCC patients
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439776

Locations
Korea, Republic of
Soonchunhyang university Hospital Cheonan
Cheonan, Chungcheongnam-do, Korea, Republic of, 330721
Soonchunhyang university hospital Bucheon
Bucheon, Gyeonggi-do, Korea, Republic of, 420767
HANYANG University Guri Hospital
Guri, Gyeonggido, Korea, Republic of, 471701
Bundang Jesaeng Hospital
Seongnam, Gyeonggido, Korea, Republic of, 463774
Chuncheon Sacred Heart Hospital
Chuncheon, Kangwondo, Korea, Republic of, 200704
Wonju Christian Hospital
Wonju, Kangwondo, Korea, Republic of, 220-701
Kyong Hee University Medical Center
Seoul, Korea, Republic of, 130702
Hanyang University Seoul Hospital
Seoul, Korea, Republic of, 133792
Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 134701
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135720
Sooncunhayng University Hospital Seoul
Seoul, Korea, Republic of, 140887
BORAMAE Medical Center
Seoul, Korea, Republic of, 156707
Chungang University Hospital
Seoul, Korea, Republic of, 156861
Sponsors and Collaborators
Hanyang University
Roche Pharma AG
  More Information

Responsible Party: Dae Won Jun, professor, Hanyang University
ClinicalTrials.gov Identifier: NCT01439776     History of Changes
Other Study ID Numbers: ML25569 
Study First Received: September 16, 2011
Last Updated: September 22, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanyang University:
chronic hepatitis C
SVR
Vit D
Peginterferon alfa 2a
Ribavirin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Vitamin D
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Immunologic Factors

ClinicalTrials.gov processed this record on December 02, 2016