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.

Phase 4

• Conditions: Hepatitis C
• Interventions: Dietary Supplement: Folic acid; Drug: placebo; Drug: Neurobion

• Registration Number: NCT02150291
• Lead Sponsor: British University In Egypt

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-27
• Last Update Submitted: 2014-05-27
• Study First Posted: 2014-05-29
• Last Update Posted: 2014-05-29
• Primary Completion: 2015-05
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Folic acid	one capsule of 5 mg of Folic acid twice daily and a tablet of Neurobion three times per day during hepatitis C treatment
Group A	Neurobion	one capsule of 5 mg of Folic acid twice daily and a tablet of Neurobion three times per day during hepatitis C treatment
Group B	Folic acid	Patients will receive one capsule of 5 mg of Folic acid twice daily during hepatitis C treatment
Group C	Neurobion	Patients will receive a tablet of Neurobion three times per day during hepatitis C treatment
Group D	placebo	Patients will receive matching placebo capsule to take during hepatitis C treatment

Primary Outcome Measures

Name	Time	Method
Effect of folic acid and/or Vitamin B complex to prevent adverse effect of pegylated interferon and ribavirin	1 YEAR	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.

Secondary Outcome Measures

Name	Time	Method
Effect of folic acid and/or Vitamin B complex on the efficacy of pegylated interferon and ribavirin.	1 year and 6 month after end of treatment	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 defined as undetectable serum HCV RNA (\< 51 IU/ml) 24 weeks after the completion of treatment.

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Abbasiya, Egypt