Clinical trial NCT02690103: Response Modifier (Arabinoxylan Rice Bran/MGN-3/Biobran) With Interferon-Alpha for HCV
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Arabinoxylan
HCV
Viremia
Biobran
PEG interferon
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan
name: University of California, Los Angeles
First posted: 2016-02-24
Enrollment: 37
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Effect of BioBran on the viraemia levels in chronic HCV infected patients
timeFrame: 3-month post treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University, Egypt
name: Hosny Salama, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University, Egypt
name: Abdel Rahaman Zekry, PhD
role: STUDY_DIRECTOR
affiliation: University of California , Los Angeles, USA
name: Mamdouh Ghoneum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University , Egypt
name: Tarneem Darwish, MD
role: STUDY_CHAIR
affiliation: Cairo University , Egypt
name: Dalia Omran, MD
role: STUDY_CHAIR
affiliation: Cairo University , Egypt
name: Rasha Ahmed, MD
role: STUDY_CHAIR
affiliation: Cairo University , Egypt
name: Sherif Mousa, MD
role: STUDY_CHAIR
affiliation: Cairo University , Egypt
name: Sherine Abdel alim, MD
role: STUDY_CHAIR
affiliation: Cairo University , Egypt
name: Hany Khattab, MD
role: STUDY_CHAIR
affiliation: Cairo University , Egypt
name: Mervat Al Ansary, MD
role: STUDY_CHAIR
affiliation: Cairo University , Egypt
name: Nemat Kasem, MD
role: STUDY_CHAIR
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