Back to resultsA 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.
Primary Purpose
Hepatitis C
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Folic acid
Neurobion
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis C
Eligibility Criteria
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.
Sites / Locations
- Ain Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Group A
Group B
Group C
Group D
Arm Description
one capsule of 5 mg of Folic acid twice daily and a tablet of Neurobion three times per day during hepatitis C treatment
Patients will receive one capsule of 5 mg of Folic acid twice daily during hepatitis C treatment
Patients will receive a tablet of Neurobion three times per day during hepatitis C treatment
Patients will receive matching placebo capsule to take during hepatitis C treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 defined as undetectable serum HCV RNA (< 51 IU/ml) 24 weeks after the completion of treatment.
Full Information
NCT ID
NCT02150291
First Posted
May 27, 2014
Last Updated
May 27, 2014
Sponsor
British University In Egypt
Collaborators
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT02150291
Brief 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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British University In Egypt
Collaborators
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
one capsule of 5 mg of Folic acid twice daily and a tablet of Neurobion three times per day during hepatitis C treatment
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients will receive one capsule of 5 mg of Folic acid twice daily during hepatitis C treatment
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Patients will receive a tablet of Neurobion three times per day during hepatitis C treatment
Arm Title
Group D
Arm Type
Placebo Comparator
Arm Description
Patients will receive matching placebo capsule to take during hepatitis C treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic acid
Intervention Type
Drug
Intervention Name(s)
Neurobion
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Effect of folic acid and/or Vitamin B complex to prevent adverse effect of pegylated interferon and ribavirin
Description
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.
Time Frame
1 YEAR
Secondary Outcome Measure Information:
Title
Effect of folic acid and/or Vitamin B complex on the efficacy of pegylated interferon and ribavirin.
Description
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.
Time Frame
1 year and 6 month after end of treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osama A Ahmed
Phone
01006154809
Email
dros1977@hotmail.com
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
State/Province
Abbasiya
ZIP/Postal Code
11566.
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama A Ahmed
Phone
01006154809
Email
dros1977@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nermeen N Ashoush
12. IPD Sharing Statement
Learn more about this trial
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.
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