Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?

Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve SVR in Genotype 2,3 Chronic Hepatitis C Patients?

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01151397

Enrollment

Registered

2010-06-28

Start date

2011-08-31

Completion date

2012-07-31

Last updated

2011-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

SVR, VITAMIN D, Hepatitis C, Genotype 2,3, Naive, RVR

Brief summary

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines 1. Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks) 2. whether Vitamin D levels predicts negative treatment outcome.

Detailed description

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2, 3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, for 3 months therapy could improve viral response. The working hypothesis is that 3 months therapy with Vitamin D + Peg + Ribavirin significantly improves RVR, EVR, and SVR.

Interventions

DRUGPeg + Vitamin D + Ribavirin

Peg+ Vitamin D+ Ribavirin for 3 months

DRUGPeg + Ribavirin

Peg+ Ribavirin for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 18 to 65 years of age * chronic genotype 2,3 HCV infection * treatment Naive negative sero for HBV, HDV and HIV viral infections * absolute neutrophil count of \>1500 per cubic millimeter * a platelet count of \>90,000 per cubic millimeter normal hemoglobin level

Exclusion criteria

* decompensated liver disease (cirrhosis with CP score \>9) * another cause of clinically significant liver disease hepato cellular carcinoma * psychiatric Disorder * chronic heart failure * pregnant women * uncontrolled diabetes with retinopathy Arrhythmia Active CAD * positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease

Design outcomes

Primary

Measure	Time frame	Description
sustained virologic response (SVR)rate	24 weeks	the SVR rate data will be collected and compared for 2 groups

Countries

Israel

Contacts

Primary ContactAssy Nimer

assy.n@ziv.health.gov.il+97246828445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026