Clinical trial NCT01439776: Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Keywords: chronic hepatitis C
SVR
Vit D
Peginterferon alfa 2a
Ribavirin
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2011-09-23
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control: Peg-ING + ribavirin Treatment: peg-INF+ ribavirin + Vitamin D
Primary purpose: TREATMENT

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.

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 criteria: Inclusion Criteria:

* Chronic genotype 1-3 HCV infection
* Treatment Naive

Exclusion Criteria:

* Child B and C
* HCC patients
* Pregnancy

Primary outcomes:
measure: Number of participants with Sustained virologic response (SVR)
timeFrame: 24w after completing Peg/RBV
Secondary outcomes:
measure: Number of participants with End of treatment response (ETR)
timeFrame: 48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3
measure: Number of participants with Rapid virological response (RVR)
timeFrame: Week 4
measure: Number of participants with Early virological response (EVR)
timeFrame: Week 12
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang university Hospital Cheonan
state: Chungcheongnam-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang university hospital Bucheon
state: Gyeonggi-do
city: Guri
country: Korea, Republic of
facility: HANYANG University Guri Hospital
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: Bundang Jesaeng Hospital
state: Gyeonggido
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Kangwondo
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
state: Kangwondo
city: Seoul
country: Korea, Republic of
facility: Kyong Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Sooncunhayng University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: BORAMAE Medical Center
city: Seoul
country: Korea, Republic of
facility: Chungang University Hospital
Study officials:
References: