Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients (Addwin)
This study is not yet open for participant recruitment.
Verified September 2011 by Hanyang University
Sponsor:
Hanyang University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Other Name: Vit D
|
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439776
Contacts
| Contact: Daewon Jun, professor | 82222909501 | noshin@hanyang.ac.kr |
| Contact: Jungmin Cho, CRC | 82222909501 | 01sin03@naver.com |
Locations
| Korea, Republic of | |
| Soonchunhyang university Hospital Cheonan | Not yet recruiting |
| Cheonan, Chungcheongnam-do, Korea, Republic of, 330721 | |
| Contact: Saehwan Lee, Professor stevesh@schmc.ac.kr | |
| Principal Investigator: Saehwan Lee, Professor | |
| Soonchunhyang university hospital Bucheon | Not yet recruiting |
| Bucheon, Gyeonggi-do, Korea, Republic of, 420767 | |
| Contact: Sanggyune Kim, professor mcnulty@schbc.ac.kr | |
| Principal Investigator: Sanggyune Kim, professor | |
| HANYANG University Guri Hospital | Not yet recruiting |
| Guri, Gyeonggido, Korea, Republic of, 471701 | |
| Contact: Joohyun Sohn, Professor sonjh@hanyang.ac.kr | |
| Principal Investigator: Joohyun Sohn, Professor | |
| Bundang Jesaeng Hospital | Not yet recruiting |
| Seongnam, Gyeonggido, Korea, Republic of, 463774 | |
| Contact: Bohyun Kim, M.D. bohkim@medimail.co.kr | |
| Principal Investigator: Bohyun Kim, Kwajang | |
| Chuncheon Sacred Heart Hospital | Not yet recruiting |
| Chuncheon, Kangwondo, Korea, Republic of, 200704 | |
| Contact: Kitae Suk, Professor ktsuk@hallym.ac.kr | |
| Principal Investigator: Kitae Suk, Professor | |
| Wonju Christian Hospital | Not yet recruiting |
| Wonju, Kangwondo, Korea, Republic of, 220-701 | |
| Contact: Munyeong Kim, Professor | |
| Principal Investigator: Munyeong Kim, Professor | |
| Sooncunhayng University Hospital Seoul | Not yet recruiting |
| Seoul, Korea, Republic of, 140887 | |
| Contact: Soungwon Jeong, professor jeongsw@hosp.sch.ac.kr | |
| Principal Investigator: Soungwon Jeong, Professor | |
| BORAMAE Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 156707 | |
| Contact: Won Kim, professor drwon1@snu.ac.kr | |
| Principal Investigator: Won Kim, Professor | |
| Gangnam Severance Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 135720 | |
| Contact: Jakyung Kim, Professor ceciliak@yuhs.ac | |
| Principal Investigator: Jakyung Kim, Professor | |
| Kyong Hee University Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 130702 | |
| Contact: JaeJoon Shim, Professor joyshim@khu.ac.kr | |
| Principal Investigator: JaeJoon Shim, Professor | |
| Chungang University Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 156861 | |
| Contact: Hyunwoong Lee, Professor lhwdoc@hanmail.net | |
| Principal Investigator: Hyunwoong Lee, Professor | |
| Kangdong Sacred Heart Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 134701 | |
| Contact: Hyungsu Kim, Professor hskim@hallym.or.kr | |
| Principal Investigator: Hyungsoo Kim, Professor | |
| Hanyang University Seoul Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 133792 | |
| Contact: Daewon Jun, Professor noshin@hanyang.ac.kr | |
| Principal Investigator: Daewon Jun, Professor | |
Sponsors and Collaborators
Hanyang University
Roche Pharma AG
More Information
No publications provided
| 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, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Vitamin D Vitamins |
Ribavirin Peginterferon alfa-2a Interferon-alpha Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances Antiviral Agents Anti-Infective Agents Therapeutic Uses Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013