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

NCT01439776 | Completed Phase 4

• 1 other identifier: ML25569
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Hepatitis C

Keywords

chronic hepatitis C; SVR; Vit D; Peginterferon alfa 2a; Ribavirin

Outcome Measures

Primary Outcomes (1)

• Number of participants with Sustained virologic response (SVR)

  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.

  24w after completing Peg/RBV

Secondary Outcomes (3)

• Number of participants with End of treatment response (ETR)

  48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3

• Number of participants with Rapid virological response (RVR)

  Week 4

• Number of participants with Early virological response (EVR)

  Week 12

Study Arms (2)

Peginterferon alfa 2a+Ribavirin

NO INTERVENTION

standard of care for HCV : peginterferon alfa 2a and ribavirin

Vit D+Peginterferon alfa 2a+Ribavirin

EXPERIMENTAL

VitD+Peginterferon alfa 2a+Ribavirin

Drug: Vit D

Interventions

Vit D DRUG

800IU/day

Vit D+Peginterferon alfa 2a+Ribavirin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic genotype 1-3 HCV infection
• Treatment Naive

You may not qualify if:

• Child B and C
• HCC patients
• Pregnancy

Sponsors & Collaborators

• Hanyang University: lead
• Roche Pharma AG: collaborator

Study Sites (13)

Soonchunhyang university Hospital Cheonan

Cheonan, Chungcheongnam-do, 330721, South Korea

Location

Soonchunhyang university hospital Bucheon

Bucheon-si, Gyeonggi-do, 420767, South Korea

Location

HANYANG University Guri Hospital

Guri-si, Gyeonggido, 471701, South Korea

Location

Bundang Jesaeng Hospital

Seongnam, Gyeonggido, 463774, South Korea

Location

Chuncheon Sacred Heart Hospital

Chuncheon, Kangwondo, 200704, South Korea

Location

Wonju Christian Hospital

Wŏnju, Kangwondo, 220-701, South Korea

Location

Kyong Hee University Medical Center

Seoul, 130702, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 133792, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, 134701, South Korea

Location

Gangnam Severance Hospital

Seoul, 135720, South Korea

Location

Sooncunhayng University Hospital Seoul

Seoul, 140887, South Korea

Location

BORAMAE Medical Center

Seoul, 156707, South Korea

Location

Chungang University Hospital

Seoul, 156861, South Korea

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Vitamin D add
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Control: Peg-ING + ribavirin Treatment: peg-INF+ ribavirin + Vitamin D

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 23, 2011
• Study Start: September 1, 2011
• Primary Completion: December 15, 2017
• Study Completion: January 20, 2018
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

KR (13)