NCT02215525

Brief Summary

A Randomized, Open-Label, Study to evaluate and compare the efficacy and safety, of extracorporeal irradiation of circulating blood by UVA with antioxidant as a supplement (Selenium containing food supplement herbal tablets) in the treatment of non-cirrhotic subjects with chronic hepatitis C.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 13, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

June 24, 2014

Last Update Submit

August 11, 2014

Conditions

Hepatitis C

Keywords

HCVUVAHerbal therapy

Outcome Measures

Primary Outcomes (1)

  • sustained virological response (SVR) at 12 weeks

    SVR is defined as an absence of detectable HCV RNA in the serum with use of an assay with a sensitivity of at least 50 IU/mL.

    12 weeks after the end of treatment

Secondary Outcomes (1)

  • Sustained Virological Response (SVR) at 24 weeks

    24 weeks after completion of the course of treatment.

Study Arms (2)

UVA and Herbal

EXPERIMENTAL

Twenty four daily one hour sessions using Extra-corporeal electro-magnetic irradiation device combined with Herbal Food Supplement Selenium containing tables as an Anti Oxidant (Tablet A) starting 10 days before the radiation sessions and to continue for 24 weeks

Device: UVA

Herbal

EXPERIMENTAL

Chronic HCV patients, non complicated will be treated by Herbal tablets only . 500 mg twice tablets every 6 hours daily for 6 months.

Dietary Supplement: Herbal

Interventions

UVADEVICE

device uses UVA

Also known as: UVA device
UVA and Herbal
HerbalDIETARY_SUPPLEMENT

Herbal tablets, 1000 mg every 6 hours daily for 6 months

Also known as: Herbal tablets
Herbal

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female between the age of 21 and 60 years.
  • Female subjects of childbearing potential must be willing to use effective form of birth control.
  • Sexually active fertile females in childbearing period must have negative results for pregnancy tests.
  • Sexually active fertile males must agree either him or his wife to practicing effective form of birth control.
  • Subject should be treatment: Non cirrhotic HCV chronic Hepatitis.
  • Subjects must be able to understand and to adhere to the study visits schedule.
  • Body mass index (BMI) is \>18 to \<35kg/m2.
  • Must voluntarily sign and date an informed consent, approved by an Institutional Review Board/Ethics Committee (IRB/EC), prior to the initiation of any study-specific procedures.
  • Chronic HCV for at least 6 months prior to study enrolment. Chronic HCV infection is defined as one of the following:
  • Positive for anti-HCV antibody or HCV RNA at least 6 months before Screening, and positive for HCV RNA and anti-HCV antibody at the time of Screening; OR
  • Positive for anti-HCV antibody and HCV RNA at the time of Screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrolment with evidence of chronic hepatitis C disease).
  • Absence of cirrhosis judged by documented results of :-
  • Liver Ultrasound. OR
  • Fibro Test score of ≤ 0.75 and Aspartate Amino transferase to Platelet Ratio Index (APRI) ((AST/AST ULN)X100)/Plt in thousands) ≤ 2 at Screening, OR
  • FibroScan® result of \<14.5kPa, OR
  • +3 more criteria

You may not qualify if:

  • History of severe, life-threatening or other significant sensitivity to any drug.
  • Females who are pregnant or breast feeding.
  • Recent (within 6-months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
  • Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (anti-HIV Ab).
  • Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) and echocardiography that make the subject an unsuitable candidate for this study in the opinion of the Investigator.
  • History of uncontrolled seizures, cancer, or uncontrolled diabetes, as defined by a HbA1C level \>8.0%.
  • Any current or past clinical evidence of cirrhosis , a history or presence of ascites, oesophageal varices, or hepatic encephalopathy.
  • Known cause of liver disease other than chronic HCV infection.
  • Screening laboratory analyses show any of the following abnormal laboratory results:
  • Alanine amino transferase (ALT) \>5X upper limit of normal (ULN),
  • Aspartate amino transferase (AST) \>5X upper limit of normal (ULN),
  • Calculated creatinine clearance (using Cockcroft-Gault method) \<50mL/min,
  • Albumin\<lower limit of normal (LLN),
  • Prothrombin time INR \> 1.5,
  • Haemoglobin \< 11 %,
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EMMS

Cairo, Heliopolis, 11613, Egypt

RECRUITING

Related Publications (13)

  • Lindsay KL. Introduction to therapy of hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S114-20. doi: 10.1053/jhep.2002.36226.

    PMID: 12407584BACKGROUND

  • Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. No abstract available.

    PMID: 19330875BACKGROUND

  • Zeuzem S, Heathcote EJ, Shiffman ML, Wright TL, Bain VG, Sherman M, Feinman SV, Fried MW, Rasenack J, Sarrazin C, Jensen DM, Lin A, Hoffman JH, Sedarati F. Twelve weeks of follow-up is sufficient for the determination of sustained virologic response in patients treated with interferon alpha for chronic hepatitis C. J Hepatol. 2003 Jul;39(1):106-11. doi: 10.1016/s0168-8278(03)00187-9.

    PMID: 12821051BACKGROUND

  • Martinot-Peignoux M, Stern C, Maylin S, Ripault MP, Boyer N, Leclere L, Castelnau C, Giuily N, El Ray A, Cardoso AC, Moucari R, Asselah T, Marcellin P. Twelve weeks posttreatment follow-up is as relevant as 24 weeks to determine the sustained virologic response in patients with hepatitis C virus receiving pegylated interferon and ribavirin. Hepatology. 2010 Apr;51(4):1122-6. doi: 10.1002/hep.23444.

    PMID: 20069649BACKGROUND

  • Mohamoud YA, Mumtaz GR, Riome S, Miller D, Abu-Raddad LJ. The epidemiology of hepatitis C virus in Egypt: a systematic review and data synthesis. BMC Infect Dis. 2013 Jun 24;13:288. doi: 10.1186/1471-2334-13-288.

    PMID: 23799878BACKGROUND

  • Moysan A, Marquis I, Gaboriau F, Santus R, Dubertret L, Morliere P. Ultraviolet A-induced lipid peroxidation and antioxidant defense systems in cultured human skin fibroblasts. J Invest Dermatol. 1993 May;100(5):692-8. doi: 10.1111/1523-1747.ep12472352.

    PMID: 8491992BACKGROUND

  • Ridley AJ, Whiteside JR, McMillan TJ, Allinson SL. Cellular and sub-cellular responses to UVA in relation to carcinogenesis. Int J Radiat Biol. 2009 Mar;85(3):177-95. doi: 10.1080/09553000902740150.

    PMID: 19296341BACKGROUND

  • Girard PM, Pozzebon M, Delacote F, Douki T, Smirnova V, Sage E. Inhibition of S-phase progression triggered by UVA-induced ROS does not require a functional DNA damage checkpoint response in mammalian cells. DNA Repair (Amst). 2008 Sep 1;7(9):1500-16. doi: 10.1016/j.dnarep.2008.05.004. Epub 2008 Jul 7.

    PMID: 18603484BACKGROUND

  • Ferguson LR, Karunasinghe N, Zhu S, Wang AH. Selenium and its' role in the maintenance of genomic stability. Mutat Res. 2012 May 1;733(1-2):100-10. doi: 10.1016/j.mrfmmm.2011.12.011. Epub 2012 Jan 5.

    PMID: 22234051BACKGROUND

  • MILEY G, CHRISTENSEN JA. Ultraviolet blood irradiation therapy; further studies in acute infections. Am J Surg. 1947 Apr;73(4):486-93. doi: 10.1016/0002-9610(47)90330-9. No abstract available.

    PMID: 20290583BACKGROUND

  • Efficacy of ultraviolet blood irradiation therapy in the control of staphylococcemias. The American Journal of Surgery, Volume 64, Issue 3, June 1944, Pages 313-322

    BACKGROUND

  • OLNEY RC. Treatment of viral hepatitis with the Knott technic of blood irradiation. Am J Surg. 1955 Sep;90(3):402-9. doi: 10.1016/0002-9610(55)90777-7. No abstract available.

    PMID: 13238699BACKGROUND

  • George Miley Ultraviolet blood irradiation therapy (Knott technic) in acute pyogenic infections. The American Journal of Surgery, Volume 57, Issue 3, September 1942, Pages 493-50

    BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Tayseer A Abdulaal, M.D.

    EMMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tayseer A Abdulaal, M.D.

CONTACT

+201223407675tayseer70@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2014

First Posted

August 13, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

May 1, 2015

Last Updated

August 13, 2014

Record last verified: 2014-07

Locations

EG(1)