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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01151397
• Other study ID #: Genotype 2,3 HCV +Vitamin D
• Status: Not yet recruiting
• Phase: N/A
• First received: June 16, 2010
• Last updated: April 27, 2011
• Start date: August 2011
• Est. completion date: July 2012

Study information

• Verified date: June 2010
• Source: Ziv Hospital
• Contact: Assy Nimer
• Phone: +97246828445
• Email: assy.n[@]ziv.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peg + Vitamin D + Ribavirin
Peg+ Vitamin D+ Ribavirin for 3 months
• Peg + Ribavirin
Peg+ Ribavirin for 6 months

Locations

Country	Name	City	State
Israel	Ziv medical center liver unit	Safed, Israel

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sustained virologic response (SVR)rate	the SVR rate data will be collected and compared for 2 groups	24 weeks	No