Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201507001055177 Date of Approval: 05/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title HEPANTIVIR CLINICAL TRIAL
Official scientific title EVALUATION OF THE EFFICACY OF HEPANTIVIR (SECURININE) IN PATIENTS WITH CHRONIC HEPATITIS B INFECTION
Brief summary describing the background and objectives of the trial Hepatitis B viral infection is endemic in sub-saharan Africa including Nigeria and is an important contributory cause of morbidity and mortality. It is estimated that more than 10% of the Nigerian population is chronically infected, and nearly 30% of these stand the risk of developing liver cirrhosis and other complications including cancer and liver failure if nothing is done. Approved therapy for this infection includes interferon (&2 and B) and the nuceoside analogues lamivudine, entecavir, adefovir, tenofovir, and telbivudine). Their efficacy in most studies has varied from about 30 to 60%, and is influenced by viral and host factors. Besides the very high cost of these medications which makes them unaffordable by majority of patients. Some products like lamivudine have low barrier to resistance. Hence the need for affordable, cheap, and affordable agents. A plant derived product securinine (Hepantivir) has been shown in initial evaluation to demonstrate antiviral activity against HBV infection. We seek in this trial to evaluate its efficacy, and evaluate any adverse effects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HEPATITIS,Infections and Infestations
Sub-Disease(s) or condition(s) being studied HEPATITIS
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2015
Actual trial start date
Anticipated date of last follow up 31/05/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation by picking a number from a cartoon of numbers 1 to 25A and 1-25B. A refers to treatment arm A and B to treatment arm B By putting the numbers into a carton Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group A 300mg 6 months 300mg Tenofovir (1 tablet) daily 25 Active-Treatment of Control Group
Experimental Group B 3 capsules thrices daily 6 months Securinine 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Fifty consecutive and consenting patients being managed by gastroenterology unitwith clinical and biochemical features as well as serological evidence of chronic hepatitis B infection and who meet the study criteria- 18 years and above, HBsAg positive with elevated serum ALT, Serum HBV DNA > 2000iu/ml No consent, presence of underlying liver malignancy, presence of co-morbidities eg end-organ failure 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No LASUTH ETHICS COMMITEE
Ethics Committee Address
Street address City Postal code Country
LASUTH LAGOS Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvement in symptoms, laboratory measurement including transaminase and HBV load as well as any adverse event will be compared between the treatment arm and tenofovir using chi sqaure test. 2 months 4 months 6 months
Secondary Outcome Absence of HBV DNA 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
GASTROENTEROLOGY DEPT, LAGOS STATE UNIVERSITY TEACHING HOSPITAL SOBO AROBIODU, GRA IKEJA LAGOS Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
BOLAR PHARMACEUTICALS LTD 72 ADENIYI JONES AVENUE, IKEJA LAGOS Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor BOLAR PHARMACEUTICALS LTD 72 ADENIYI JONES AVENUE, IKEJA LAGOS Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
GGIA LAB Place de la Victoire, Lome BP 795 LOME Togo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator DR ONYEKWERE ifymobi@yahoo.com +2348033080186 LASUTH
City Postal code Country Position/Affiliation
IKEJA LAGOS Nigeria CONSULTANT
Role Name Email Phone Street address
Public Enquiries BOLADE SOREMEKUN b.soremekun@bolarpharm.com +2348034499670 72 ADENIYI JONES AVE IKEJA
City Postal code Country Position/Affiliation
LAGOS Nigeria SPONSOR
Role Name Email Phone Street address
Scientific Enquiries OSCAR D'ALMEDIA ggialabs@yahoo.fr +2282225949 place de la victoire
City Postal code Country Position/Affiliation
LOME Togo RESEARCHER
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information