Response Modifier (Arabinoxylan Rice Bran/MGN-3/Biobran) With Interferon-Alpha for HCV

NCT02690103 | Completed Phase 2 DMC

• 1 other identifier: 3
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

Current treatments for Hepatitis C virus (HCV) have severe side effects and are very expensive. There is a need to explore effective natural therapies against HCV that are less toxic and more cost-effective. 37 chronic HCV infected patients were randomized into two groups and treated with PEG interferon plus ribavirin for the first group or Biobran, an arabinoxylan from rice bran (1 g/day) for the second group. Viremia level, liver enzymes, γ-interferon (IFN-γ) levels in serum, and toxicity were checked before and three months after treatment.

Conditions

Hepatitis C, Chronic

Keywords

Arabinoxylan; HCV; Viremia; Biobran; PEG interferon

Outcome Measures

Primary Outcomes (1)

• Effect of BioBran on the viraemia levels in chronic HCV infected patients

  3-month post treatment

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Patients are treated with 180µg of pegylated IFN (Pegasys-Roche) subcutaneously weekly for three months. In addition, they are given ribavirin according to their body weight (1200 mg for those over 75 kg and 1000 mg for those under 75 kg).

Drug: pegylated IFN; Drug: Ribavirin

Group 2

EXPERIMENTAL

Patients are treated with Biobran, at a dose of 1g per day, allocated in packets, taken orally with meals for the three months duration of the study. Biobran is a denatured hemicellulose that is obtained by reacting rice bran hemicellulose with multiple carbohydrate hydrolyzing enzymes from Shiitake mushrooms. It is a polysaccharide that contains ß-1, 3-glucans, and activated hemicellulose.

Dietary Supplement: Biobran

Interventions

pegylated IFN DRUG

Patients are treated with 180µg of pegylated IFN (Pegasys-Roche) subcutaneously weekly for three months.

Group 1

Biobran DIETARY_SUPPLEMENT

Biobran, at a dose of 1g per day, allocated in packets, taken orally with meals for the three months duration of the study. Biobran is a denatured hemicellulose that is obtained by reacting rice bran hemicellulose with multiple carbohydrate hydrolyzing enzymes from Shiitake mushrooms. It is a polysaccharide that contains ß-1, 3-glucans, and activated hemicellulose. Biobran was kindly provided by Daiwa Pharmaceuticals Co. Ltd., Tokyo, Japan.

Group 2

Ribavirin DRUG

Ribavirin is prescribed according to patients body weight (1200 mg for those over 75 kg and 1000 mg for those under 75 kg).

Group 1

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with chronic HCV infection and chronic active liver diseases.

You may not qualify if:

• Patients diagnosed with chronic HBV , HIV infection , autoimmune disorders , any heart diseases , any kidney diseases or any blood disease , any neoplastic disorders.
• Pregnant or lactating ladies , and drug abusers will be excluded.

Sponsors & Collaborators

• Cairo University: lead
• Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan: collaborator
• University of California, Los Angeles: collaborator

Related Publications (29)

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  BACKGROUND

• Ghoneum M, Abedi S. Enhancement of natural killer cell activity of aged mice by modified arabinoxylan rice bran (MGN-3/Biobran). J Pharm Pharmacol. 2004 Dec;56(12):1581-8. doi: 10.1211/0022357044922.

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• Perez-Martinez A, Valentin J, Fernandez L, Hernandez-Jimenez E, Lopez-Collazo E, Zerbes P, Schworer E, Nunez F, Martin IG, Sallis H, Diaz MA, Handgretinger R, Pfeiffer MM. Arabinoxylan rice bran (MGN-3/Biobran) enhances natural killer cell-mediated cytotoxicity against neuroblastoma in vitro and in vivo. Cytotherapy. 2015 May;17(5):601-12. doi: 10.1016/j.jcyt.2014.11.001. Epub 2014 Dec 23.

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• Ghoneum M, Agrawal S. Mgn-3/biobran enhances generation of cytotoxic CD8+ T cells via upregulation of dec-205 expression on dendritic cells. Int J Immunopathol Pharmacol. 2014 Oct-Dec;27(4):523-30. doi: 10.1177/039463201402700408.

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• Ghoneum M, Jewett A. Production of tumor necrosis factor-alpha and interferon-gamma from human peripheral blood lymphocytes by MGN-3, a modified arabinoxylan from rice bran, and its synergy with interleukin-2 in vitro. Cancer Detect Prev. 2000;24(4):314-24.

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• Noaman E, Badr El-Din NK, Bibars MA, Abou Mossallam AA, Ghoneum M. Antioxidant potential by arabinoxylan rice bran, MGN-3/biobran, represents a mechanism for its oncostatic effect against murine solid Ehrlich carcinoma. Cancer Lett. 2008 Sep 18;268(2):348-59. doi: 10.1016/j.canlet.2008.04.012. Epub 2008 Jun 12.

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• Ghoneum M, Badr El-Din NK, Abdel Fattah SM, Tolentino L. Arabinoxylan rice bran (MGN-3/Biobran) provides protection against whole-body gamma-irradiation in mice via restoration of hematopoietic tissues. J Radiat Res. 2013 May;54(3):419-29. doi: 10.1093/jrr/rrs119. Epub 2013 Jan 3.

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• Ghoneum M. Anti-HIV activity by MGN-3 in vitro. XI International Conference on AIDS. Vancouver, July 7-12, 1996.

  BACKGROUND

• Tazawa K, Ichihashi K, Fuji T, Omura K, Anazawa M, Maeda H. The orally administration of the Hydrolysis Rice Bran prevents a common cold syndrome for the elderly people based on the immunomodulatory function. J Trad Med 2003; 20:132-41.

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• Salama H, Medhat E, Shaheen M, Zekri AN, Darwish T, Ghoneum M. Arabinoxylan rice bran (Biobran) suppresses the viremia level in patients with chronic HCV infection: A randomized trial. Int J Immunopathol Pharmacol. 2016 Dec;29(4):647-653. doi: 10.1177/0394632016674954. Epub 2016 Oct 31.

  PMID: 27799299 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Viremia

Interventions

polysaccharide MGN3; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Hosny Salama, MD

  Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

• Abdel Rahaman Zekry, PhD

  Cairo University, Egypt

  STUDY DIRECTOR

• Mamdouh Ghoneum, MD

  University of California , Los Angeles, USA

  PRINCIPAL INVESTIGATOR

• Tarneem Darwish, MD

  Cairo University , Egypt

  STUDY CHAIR

• Dalia Omran, MD

  Cairo University , Egypt

  STUDY CHAIR

• Rasha Ahmed, MD

  Cairo University , Egypt

  STUDY CHAIR

• Sherif Mousa, MD

  Cairo University , Egypt

  STUDY CHAIR

• Sherine Abdel alim, MD

  Cairo University , Egypt

  STUDY CHAIR

• Hany Khattab, MD

  Cairo University , Egypt

  STUDY CHAIR

• Mervat Al Ansary, MD

  Cairo University , Egypt

  STUDY CHAIR

• Nemat Kasem, MD

  Cairo University , Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 24, 2016
• Study Start: July 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02