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

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

Interventions

DRUG

pegylated IFN

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

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.

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).

Sponsors & Collaborators

• Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan

  collaborator UNKNOWN

• University of California, Los Angeles

  collaborator OTHER

• Cairo University

  lead OTHER

Principal Investigators

• Hosny Salama, MD · Cairo University, Egypt

• Abdel Rahaman Zekry, PhD · Cairo University, Egypt

• Mamdouh Ghoneum, MD · University of California , Los Angeles, USA

• Tarneem Darwish, MD · Cairo University , Egypt

• Dalia Omran, MD · Cairo University , Egypt

• Rasha Ahmed, MD · Cairo University , Egypt

• Sherif Mousa, MD · Cairo University , Egypt

• Sherine Abdel alim, MD · Cairo University , Egypt

• Hany Khattab, MD · Cairo University , Egypt

• Mervat Al Ansary, MD · Cairo University , Egypt

• Nemat Kasem, MD · Cairo University , Egypt

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2015-06-30

Completion

2015-06-30