A Pilot Study to Assess the Efficacy and Safety of Folic Acid and/or Vitamin B Complex on Hepatitis C Infected Patients Treated With Pegylated Interferon and Ribavirin.

Hepatitis C Clinical Trial

Official title:

A Pilot Study to Assess the Efficacy and Safety of Folic Acid and/or Vitamin B Complex on Hepatitis C Infected Patients Treated With Pegylated Interferon and Ribavirin.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02150291
• Other study ID #: 2107
• Status: Recruiting
• Phase: Phase 4
• First received: May 27, 2014
• Last updated: May 27, 2014
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: May 2014
• Source: British University In Egypt
• Contact: Osama A Ahmed
• Phone: 01006154809
• Email: dros1977[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Since success of the combination therapy with PEG-IFN and RBV is contingent on maintaining adequate doses of both drugs throughout the treatment period, the emergence of hematological side effects is expected and requires intervention. The hematological adverse effects lead to a trade-off between continuing the treatment with optimal dosage, to clear the virus, exacerbating thereby the side effects versus decreasing dosage to relieve severe anemia, reducing thereby the chances of achieving sustained virological response (SVR). Therefore, we aimed at giving Folic acid® and Neurobion® to HCV-infected patients during treatment with different types of PEG-IFN plus ribavirin in an attempt to evaluate its efficacy and safety as a prophylactic treatment to prevent hematological adverse effects. Preventing adverse effects without interfering with the therapeutic efficacy of different types of PEG-IFN plus ribavirin in HCV patients will lead to better health outcomes and improvement in their quality of life (HRQOL).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Chronic hepatitis C patients of both sexes were eligible for inclusion if they were HCV RNA positive, naive to PEG-INF and RBV, and had abnormal serum alanine transaminase levels on two occasions during the preceding six months.

Exclusion Criteria:

Patients with significant hematological abnormalities at baseline, such as neutropenia (ANC <1200 x 103 cells/µL), thrombocytopenia (<70 x 103 cells/ µL), and anemia (<10.5 g/dL), were excluded. Patients were also excluded from study participation if they had serum creatinine =1.70 mg/dL (150 µmol), hepatitis B surface antigen positivity, decompensated cirrhosis, or other forms of liver disease not attributable to HCV. Patients with severe depression or psychosis, uncontrolled seizures, poorly controlled cardiovascular disease, diabetes mellitus, or autoimmune disorders were also ineligible. Women were ineligible for study participation if they were pregnant or unwilling to use at least 2 forms of effective contraception during the entire study period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Dietary Supplement:
• Folic acid

Drug:
• Neurobion

• placebo

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo	Abbasiya

Sponsors (2)

Lead Sponsor	Collaborator
British University In Egypt	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of folic acid and/or Vitamin B complex to prevent adverse effect of pegylated interferon and ribavirin	Maintain absolute neutrophil count (ANC) levels >750 cells/mm3, hemoglobin levels >10.5 g/dL to prevent adjustment to the PEG-INF dose or its temporary suspension. Moreover, to maintain a sustained platelet level above 45,000 platelet/mm3. During therapy thrombocytopenia was assessed at levels of 50,000 and 25,000/µl, since these levels are the usual thresholds for dose reductions or discontinuation of peginterferon alfa/ribavirin therapy.	1 YEAR	No
Secondary	Effect of folic acid and/or Vitamin B complex on the efficacy of pegylated interferon and ribavirin.	Biochemical improvement of liver function and sustained virological response (SVR). Biochemical improvement was defined as a decrease in alanine transaminase (ALT) level and Aspartate transaminase (AST). A sustained virological response (SVR) is de?ned as undetectable serum HCV RNA (< 51 IU/ml) 24 weeks after the completion of treatment.	1 year and 6 month after end of treatment	No