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

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ClinicalTrials.gov Identifier: NCT02690103
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Collaborators:
Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan
University of California, Los Angeles
Information provided by (Responsible Party):
Hosny Salama, Cairo University

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.


Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: pegylated IFN Dietary Supplement: Biobran Drug: Ribavirin Phase 2

Detailed Description:

The current study is a preliminary investigation of whether Biobran has the ability to restrict viremia in patients with chronic HCV or not. In addition, we examined the effect of Biobran on liver enzymes and inflammation as well as assessing any side effects of Biobran. Results show that treatment with Biobran resulted in a significant reduction in the viral load, an increase in liver enzymes, and patients reported good health.

For the randomized trial, we selected 37 patients who had been admitted to El-Kasr El-Aini Hospital at Cairo, Egypt. The patients had been diagnosed with genotype 4 HCV infection. The study was approved by Cairo University Hospital, Cairo, Egypt and by IRB at Charles Drew school of medicine and Science, Los Angeles, CA, USA. The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in the prior approval by Cairo University, El-Kasr El-Aini Hospital, Cairo, Egypt and by the Institutional Review Board (IRB) at Cairo University, Egypt and Charles R Drew University (CDU), Los Angeles, CA., USA.

Thirty-seven patients of both sexes (23 males and 14 females) with HCV (genotype 4), between the ages of 15 and 69, participated in the current study. Informed consent was obtained from all participants.

The patients were divided randomly into two groups: the Biobran group and the PEG interferon plus ribavirin (control) group . Prior to treatment, clinical characteristics were determined for the patients in each group. The clinical characteristics of the HCV patients were investigated for hepatitis C, alpha-fetoprotein (AFP) levels, total leucocyte count (TLC), Platelet (PLT) count, Hemoglobin (Hb) levels, triglyceride (TG) levels, glycated hemoglobin (HbA1c) levels, blood clotting using International Normalized Ratio (INR), creatinine per milliliter (Cr/ml), and random blood sugar (RBG).

Patients in the control group were treated with 180µg of pegylated IFN (Pegasys-Roche) subcutaneously weekly for three months. In addition, they were given ribavirin according to their body weight (1200 mg for those over 75 kg and 1000 mg for those under 75 kg). The Biobran group was 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. Biobran was kindly provided by Daiwa Pharmaceuticals Co. Ltd., Tokyo, Japan.

The patients were divided randomly into two groups: the Biobran group and the PEG interferon plus ribavirin (control) group . Prior to treatment, clinical characteristics were determined for the patients in each group. The clinical characteristics of the HCV patients were investigated for hepatitis C, alpha-fetoprotein (AFP) levels, total leucocyte count (TLC), Platelet (PLT) count, Hemoglobin (Hb) levels, triglyceride (TG) levels, glycated hemoglobin (HbA1c) levels, blood clotting using International Normalized Ratio (INR), creatinine per milliliter (Cr/ml), and random blood sugar (RBG).

Viral load levels, toxicity, liver enzymes, and γ-interferon (IFN-γ) levels were examined before and three months after treatment. Viral load was examined by quantitative polymerase chain reaction (PCR) test using COBAS® TaqMan® Analyzer (Roche Corporation). IFN-γ, AFP, ALT, and AST levels were analyzed using specific Elisa Kits, which were performed by Spectrum Chemical Manufacturing Corporation, Gardena, CA, USA, and toxicity was assessed by a questionnaire, physician observation, and laboratory results.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Clinical Study of a Biological Response Modifier (Arabinoxylan Rice Bran/MGN-3/Biobran) With Interferon-Alpha for the Treatment of Hepatitis C Infection
Study Start Date : July 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arm Intervention/treatment
Active Comparator: Group 1
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
Patients are treated with 180µg of pegylated IFN (Pegasys-Roche) subcutaneously weekly for three months.

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

Experimental: Group 2
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
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.




Primary Outcome Measures :
  1. Effect of BioBran on the viraemia levels in chronic HCV infected patients [ Time Frame: 3-month post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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): NCT02690103


Sponsors and Collaborators
Cairo University
Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan
University of California, Los Angeles
Investigators
Principal Investigator: Hosny Salama, MD Cairo University, Egypt
Study Director: Abdel Rahaman Zekry, PhD Cairo University, Egypt
Principal Investigator: Mamdouh Ghoneum, MD University of California , Los Angeles, USA
Study Chair: 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

Publications:
University of Washington/Seattle STD/HIV Prevention Training Center. Hepatitis Web Study. 2013. Available at: http://www.cdc.gov/hepatitis/Resources/Professionals/PDFs/ABCTable.pdf. Accessed 29 November 2015.
A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt. Sievert, William et al. Liver Int. 31. 61-80. 2011. Available at: http://www.dailynewsegypt.com/2015/01/05/lawsuit-targets-army-officials-claiming-hiv-hepatitis-c-cure/. Accessed 29 November 2015.
Ghoneum M. Enhancement of human natural killer cell activity by modified arabinoxylane from rice bran (MGN-3). Int J Immunotherapy 1998; XIV(2):89-99.
Ghoneum M. Anti-HIV activity by MGN-3 in vitro. XI International Conference on AIDS. Vancouver, July 7-12, 1996.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hosny Salama, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT02690103     History of Changes
Other Study ID Numbers: 3
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hosny Salama, Cairo University:
Arabinoxylan
HCV
Viremia
Biobran
PEG interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Interferons
Ribavirin
Interferon-alpha
Immunologic Factors
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs