NCT02150291

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: British University In Egypt · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Folic acid
DRUG	Neurobion
DRUG	placebo

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-05-01
• Completion: 2015-11-01
• First posted: 2014-05-29
• Last updated: 2014-05-29

Locations

1 site across 1 country: Egypt