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.

NCT02150291 | Unknown Phase 4 DMC

• 1 other identifier: 2107
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (4)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

Patients will receive one capsule of 5 mg of Folic acid twice daily during hepatitis C treatment

Dietary Supplement: Folic acid

Group C

ACTIVE COMPARATOR

Patients will receive a tablet of Neurobion three times per day during hepatitis C treatment

Drug: Neurobion

Group D

PLACEBO COMPARATOR

Patients will receive matching placebo capsule to take during hepatitis C treatment

Drug: placebo

Interventions

Folic acid DIETARY_SUPPLEMENT

Group A; Group B

Neurobion DRUG

Group A; Group C

placebo DRUG

Group D

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• British University In Egypt: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasiya, 11566., Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Folic Acid; Vitamin B Complex

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Osama A Ahmed

CONTACT

01006154809; dros1977@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Assistant in Clinical Pharmacy Department

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 29, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

EG (1)