Clincosm LogoSign in Get a demo

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

Sponsor
Hanyang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01439776
Collaborator
Roche Pharma AG (Industry)
222
Enrollment
13
Locations
2
Arms
23
Duration (Months)
17.1
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vit D
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
222 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2011
Anticipated Primary Completion Date :
Feb 1, 2013
Anticipated Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with Sustained virologic response (SVR) [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 Outcome Measures

  1. Number of participants with End of treatment response (ETR) [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) [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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Chronic genotype 1-3 HCV infection

  • Treatment Naive

Exclusion Criteria:

  • Child B and C

  • HCC patients

  • Pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Soonchunhyang university Hospital Cheonan Cheonan Chungcheongnam-do Korea, Republic of 330721
2 Soonchunhyang university hospital Bucheon Bucheon Gyeonggi-do Korea, Republic of 420767
3 HANYANG University Guri Hospital Guri Gyeonggido Korea, Republic of 471701
4 Bundang Jesaeng Hospital Seongnam Gyeonggido Korea, Republic of 463774
5 Chuncheon Sacred Heart Hospital Chuncheon Kangwondo Korea, Republic of 200704
6 Wonju Christian Hospital Wonju Kangwondo Korea, Republic of 220-701
7 Kyong Hee University Medical Center Seoul Korea, Republic of 130702
8 Hanyang University Seoul Hospital Seoul Korea, Republic of 133792
9 Kangdong Sacred Heart Hospital Seoul Korea, Republic of 134701
10 Gangnam Severance Hospital Seoul Korea, Republic of 135720
11 Sooncunhayng University Hospital Seoul Seoul Korea, Republic of 140887
12 BORAMAE Medical Center Seoul Korea, Republic of 156707
13 Chungang University Hospital Seoul Korea, Republic of 156861

Sponsors and Collaborators

  • Hanyang University
  • Roche Pharma AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dae Won Jun, professor, Hanyang University
ClinicalTrials.gov Identifier:
NCT01439776
Other Study ID Numbers:
  • ML25569
First Posted:
Sep 23, 2011
Last Update Posted:
Sep 23, 2011
Last Verified:
Sep 1, 2011
Keywords provided by Dae Won Jun, professor, Hanyang University
chronic hepatitis C
SVR
Vit D
Peginterferon alfa 2a
Ribavirin
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic

Study Results

No Results Posted as of Sep 23, 2011