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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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ClinicalTrials.gov Identifier: NCT02150291
Recruitment Status : Unknown
Verified May 2014 by Nermeen Nabil Ashoush, British University In Egypt.
Recruitment status was:  Recruiting
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Nermeen Nabil Ashoush, 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).

Condition or disease Intervention/treatment Phase
Hepatitis C Dietary Supplement: Folic acid Drug: Neurobion Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : May 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
one capsule of 5 mg of Folic acid twice daily and a tablet of Neurobion three times per day during hepatitis C treatment
Dietary Supplement: Folic acid
Drug: Neurobion
Active Comparator: Group B
Patients will receive one capsule of 5 mg of Folic acid twice daily during hepatitis C treatment
Dietary Supplement: Folic acid
Active Comparator: Group C
Patients will receive a tablet of Neurobion three times per day during hepatitis C treatment
Drug: Neurobion
Placebo Comparator: Group D
Patients will receive matching placebo capsule to take during hepatitis C treatment
Drug: placebo



Primary Outcome Measures :
  1. Effect of folic acid and/or Vitamin B complex to prevent adverse effect of pegylated interferon and ribavirin [ Time Frame: 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 :
  1. Effect of folic acid and/or Vitamin B complex on the efficacy of pegylated interferon and ribavirin. [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150291


Contacts
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Contact: Osama A Ahmed 01006154809 dros1977@hotmail.com

Locations
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Egypt
Ain Shams University Hospitals Recruiting
Cairo, Abbasiya, Egypt, 11566.
Contact: Osama A Ahmed    01006154809    dros1977@hotmail.com   
Principal Investigator: Nermeen N Ashoush         
Sponsors and Collaborators
British University In Egypt
Ain Shams University

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Responsible Party: Nermeen Nabil Ashoush, Lecturer Assistant in Clinical Pharmacy Department, British University In Egypt
ClinicalTrials.gov Identifier: NCT02150291     History of Changes
Other Study ID Numbers: 2107
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Folic Acid
Vitamin B Complex
Interferons
Ribavirin
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Hematinics