Efficacy of vitB12 plus standard chronic HCV treatment versus standard chronic HCV treatment on sustained virologic response rate

A comparison of vitB12 plus standard chronic HCV treatment with standard chronic HCV treatment on sustained virologic response rate

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015041720178N3

Enrollment

Registered

2015-05-03

Start date

2015-03-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Chronic viral hepatitis C. Chronic viral hepatitis C

Interventions

Intervention 1: control:: Peg-IFNa2b 1.5 mg/kg/week subcutaneously and ribavirin

according to body weight(1000 mg/day for weighing 75 kg in genotype 1 or 4 and a single ribavirin dose of 800 mg/day in genotype 2 or 3 . Intervention 2: Intervention: : Peg-IFNa2b 1.5 mg/kg/week sub

according to body weight(1000 mg/day for weighing 75 kg in genotype 1 or 4 and a single ribavirin dose of 800 mg/day in genotype 2 or 3 plus vitamin B12 5000 microgram intramuscular injection every

Treatment - Drugs

control:: Peg-IFNa2b 1.5 mg/kg/week subcutaneously and ribavirin

according to body weight(1000 mg/day for weighing 75 kg in genotype 1 or 4 and a single ribavirin dose of 800 mg/day in genotype 2 or 3 .

Intervention: : Peg-IFNa2b 1.5 mg/kg/week subcutaneously and ribavirin

according to body weight(1000 mg/day for weighing 75 kg in genotype 1 or 4 and a single ribavirin dose of 800 mg/day in genotype 2 or 3 plus vitamin B12 5000 microgram intramuscular injection ever

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:naive HCV hepatitis patients that refer to Rasoul Akram Hospital,Gastroenterology Clinic. Exclusion criteria:age70,previous treatment with interferon and/or ribavirin,concomitant causes of liver disease, such as HBV infection and autoimmune Hepatitis, alcohol user, HIV infection, hepatocellular carcinoma, decompensated cirrhosis, severe concurrent disease and contraindications to treatment including uncontrolled depression,psychosis, epilepsy, autoimmune diseases, poorlycontrolled hypertension, diabetes, heart failure and chronic obstructive pulmonary disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sustained virologic response rate. Timepoint: 24 weeks after treatment completion. Method of measurement: Quantitative HCV-PCR.	—

Secondary

Measure	Time frame
HCV genotype pattern. Timepoint: at the begining of treatment. Method of measurement: HCV genotyping.;Drug adverse effect rate. Timepoint: During treatment. Method of measurement: Data gathering sheet.;Non-responder rate. Timepoint: 12 and 24 weeks after start treatment. Method of measurement: Quantitative HCV-PCR.;Rapid viral response rate. Timepoint: 4 weeks after start treatment. Method of measurement: Quantitative HCV-PCR.;Complete early viral response rate. Timepoint: 12 weeks after start treatment. Method of measurement: Quantitative HCV-PCR.;Dropout rate. Timepoint: During treatment. Method of measurement: Data gathering sheet.;Liver steatosis and fibrosis rate. Timepoint: at first time before treatment. Method of measurement: liver fibroscan and/or biopsy.;Patient compliance rate. Timepoint: at the end of treatment. Method of measurement: Data gathering sheet.;The end-oftreatment viral response rate. Timepoint: at the end of treatment. Method of measurement: Quantitative HCV-PCR.;Virological breakthrough rate. Timepoint: During treatment. Method of measurement: Quantitative HCV-PCR.;Relapse rate. Timepoint: during 24 weeks after completing treatment. Method of measurement: Quantitative HCV-PCR.	—

Measure

Time frame

HCV genotype pattern. Timepoint: at the begining of treatment. Method of measurement: HCV genotyping.;Drug adverse effect rate. Timepoint: During treatment. Method of measurement: Data gathering sheet.;Non-responder rate. Timepoint: 12 and 24 weeks after start treatment. Method of measurement: Quantitative HCV-PCR.;Rapid viral response rate. Timepoint: 4 weeks after start treatment. Method of measurement: Quantitative HCV-PCR.;Complete early viral response rate. Timepoint: 12 weeks after start treatment. Method of measurement: Quantitative HCV-PCR.;Dropout rate. Timepoint: During treatment. Method of measurement: Data gathering sheet.;Liver steatosis and fibrosis rate. Timepoint: at first time before treatment. Method of measurement: liver fibroscan and/or biopsy.;Patient compliance rate. Timepoint: at the end of treatment. Method of measurement: Data gathering sheet.;The end-oftreatment viral response rate. Timepoint: at the end of treatment. Method of measurement: Quantitative HCV-PCR.;Virological breakthrough rate. Timepoint: During treatment. Method of measurement: Quantitative HCV-PCR.;Relapse rate. Timepoint: during 24 weeks after completing treatment. Method of measurement: Quantitative HCV-PCR.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarjan Mokhtare

Colorectal Research Center, Rasoul Akram Hospital

mokhtare.m@iums.ac.ir-marjanmokhtare@yahoo.com-mokhtaredr@gmail.com+98 21 6655 4790

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026