Hepatitis C, ChronicPhase 2NCT02690103
Response Modifier (Arabinoxylan Rice Bran/MGN-3/Biobran) With Interferon-Alpha for HCV
A Phase 2 study testing pegylated IFN, Biobran and Ribavirin in people with Hepatitis C, Chronic, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- pegylated IFN, Biobran and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with chronic HCV infection and chronic active liver diseases.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- pegylated IFN, Biobran, Ribavirin
- Keywords
- Arabinoxylan, HCV, Viremia, Biobran, PEG interferon
- Medical subject headings
- Hepatitis C, Chronic, Viremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated IFNDrug
Patients are treated with 180µg of pegylated IFN (Pegasys-Roche) subcutaneously weekly for three months.
BiobranDietary 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.
RibavirinDrug
Ribavirin is prescribed according to patients body weight (1200 mg for those over 75 kg and 1000 mg for those under 75 kg).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Dietary Supplement: Biobran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of BioBran on the viraemia levels in chronic HCV infected patients
Measured: 3-month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan, University of California, Los Angeles
- Responsible party
- Principal investigator, Hosny Salama, Cairo University
- Investigators
- Hosny Salama, MD, Principal investigator, Cairo University, EgyptAbdel Rahaman Zekry, PhD, Study director, Cairo University, EgyptMamdouh Ghoneum, MD, Principal investigator, University of California , Los Angeles, USATarneem Darwish, MD, Study chair, Cairo University , EgyptDalia Omran, MD, Study chair, Cairo University , EgyptRasha Ahmed, MD, Study chair, Cairo University , EgyptSherif Mousa, MD, Study chair, Cairo University , EgyptSherine Abdel alim, MD, Study chair, Cairo University , Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690103
- Sponsor's protocol ID
- 3
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
Sievert W, Altraif I, Razavi HA, Abdo A, Ahmed EA, Alomair A, Amarapurkar D, Chen CH, Dou X, El Khayat H, Elshazly M, Esmat G, Guan R, Han KH, Koike K, Largen A, McCaughan G, Mogawer S, Monis A, Nawaz A, Piratvisuth T, Sanai FM, Sharara AI, Sibbel S, Sood A, Suh DJ, Wallace C, Young K, Negro F. A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt. Liver Int. 2011 Jul;31 Suppl 2:61-80. doi: 10.1111/j.1478-3231.2011.02540.x.
PubMed 21651703Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011 Feb;17(2):107-15. doi: 10.1111/j.1469-0691.2010.03432.x.
PubMed 21091831Ghoneum M. Anti-HIV activity in vitro of MGN-3, an activated arabinoxylane from rice bran. Biochem Biophys Res Commun. 1998 Feb 4;243(1):25-9. doi: 10.1006/bbrc.1997.8047.
PubMed 9473473Ghoneum 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, 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.
PubMed 15563765Cholujova D, Jakubikova J, Czako B, Martisova M, Hunakova L, Duraj J, Mistrik M, Sedlak J. MGN-3 arabinoxylan rice bran modulates innate immunity in multiple myeloma patients. Cancer Immunol Immunother. 2013 Mar;62(3):437-45. doi: 10.1007/s00262-012-1344-z. Epub 2012 Sep 2.
PubMed 22941038Perez-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.
PubMed 25541298Cholujova D, Jakubikova J, Sedlak J. BioBran-augmented maturation of human monocyte-derived dendritic cells. Neoplasma. 2009;56(2):89-95. doi: 10.4149/neo_2009_02_89.
PubMed 19239320Ghoneum M, Agrawal S. Activation of human monocyte-derived dendritic cells in vitro by the biological response modifier arabinoxylan rice bran (MGN-3/Biobran). Int J Immunopathol Pharmacol. 2011 Oct-Dec;24(4):941-8. doi: 10.1177/039463201102400412.
PubMed 22230400Ghoneum 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.
PubMed 25572732Ghoneum 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.
PubMed 11059563Noaman 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.
PubMed 18554778Ghoneum 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.
PubMed 23287771Ghoneum M. Anti-HIV activity by MGN-3 in vitro. XI International Conference on AIDS. Vancouver, July 7-12, 1996.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02690103
- Acronym / sponsor ID
- 3
- Conditions
- Hepatitis C, Chronic
- Keywords
- Arabinoxylan, HCV, Viremia, Biobran, PEG interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Daiwa Pharmaceutical Corporation Co, Ltd, Tokyo 154-0024 Japan, University of California, Los Angeles
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: pegylated IFN, Drug: RibavirinPatients 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). |
| Group 2 | Experimental | Dietary Supplement: BiobranPatients 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. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with chronic HCV infection and chronic active liver diseases.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegylated IFNPatients are treated with 180µg of pegylated IFN (Pegasys-Roche) subcutaneously weekly for three months. | Drug | Group 1 |
| BiobranBiobran, 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. | Dietary supplement | Group 2 |
| RibavirinRibavirin is prescribed according to patients body weight (1200 mg for those over 75 kg and 1000 mg for those under 75 kg). | Drug | Group 1 |
Primary outcome
Effect of BioBran on the viraemia levels in chronic HCV infected patients
Time frame: 3-month post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- BackgroundUniversity 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.
- Background: PubMed 21651703Sievert W, Altraif I, Razavi HA, Abdo A, Ahmed EA, Alomair A, Amarapurkar D, Chen CH, Dou X, El Khayat H, Elshazly M, Esmat G, Guan R, Han KH, Koike K, Largen A, McCaughan G, Mogawer S, Monis A, Nawaz A, Piratvisuth T, Sanai FM, Sharara AI, Sibbel S, Sood A, Suh DJ, Wallace C, Young K, Negro F. A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt. Liver Int. 2011 Jul;31 Suppl 2:61-80. doi: 10.1111/j.1478-3231.2011.02540.x.
- Background: PubMed 21091831Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011 Feb;17(2):107-15. doi: 10.1111/j.1469-0691.2010.03432.x.
- Background: PubMed 9473473Ghoneum M. Anti-HIV activity in vitro of MGN-3, an activated arabinoxylane from rice bran. Biochem Biophys Res Commun. 1998 Feb 4;243(1):25-9. doi: 10.1006/bbrc.1997.8047.
- BackgroundGhoneum M. Enhancement of human natural killer cell activity by modified arabinoxylane from rice bran (MGN-3). Int J Immunotherapy 1998; XIV(2):89-99.
- Background: PubMed 15563765Ghoneum 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.
- Background: PubMed 22941038Cholujova D, Jakubikova J, Czako B, Martisova M, Hunakova L, Duraj J, Mistrik M, Sedlak J. MGN-3 arabinoxylan rice bran modulates innate immunity in multiple myeloma patients. Cancer Immunol Immunother. 2013 Mar;62(3):437-45. doi: 10.1007/s00262-012-1344-z. Epub 2012 Sep 2.
- Background: PubMed 25541298Perez-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.
- Background: PubMed 19239320Cholujova D, Jakubikova J, Sedlak J. BioBran-augmented maturation of human monocyte-derived dendritic cells. Neoplasma. 2009;56(2):89-95. doi: 10.4149/neo_2009_02_89.
- Background: PubMed 22230400Ghoneum M, Agrawal S. Activation of human monocyte-derived dendritic cells in vitro by the biological response modifier arabinoxylan rice bran (MGN-3/Biobran). Int J Immunopathol Pharmacol. 2011 Oct-Dec;24(4):941-8. doi: 10.1177/039463201102400412.
- Background: PubMed 25572732Ghoneum 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.
- Background: PubMed 11059563Ghoneum 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hosny Salama, MD principal investigator
Cairo University, Egypt
Abdel Rahaman Zekry, PhD study director
Cairo University, Egypt
Mamdouh Ghoneum, MD principal investigator
University of California , Los Angeles, USA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegylated IFN, Biobran and Ribavirin in people with Hepatitis C, Chronic, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of BioBran on the viraemia levels in chronic HCV infected patients (time frame: 3-month post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02690103, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.