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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003186772 Date of Registration: 12/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title DAA effect on DNA Telomere in Hepatitis C virus related Cirrhosis
Official scientific title Impact of DAAs on Leucocytic DNA Telomere Length in HCV Related Hepatic Cirrhosis.
Brief summary describing the background and objectives of the trial Direct Acting Antiviral drugs (DAA) have established an advancement in management of Hepatitis C virus related hepatic cirrhosis.Recent evidence suggested that shortening of DNA telomere may be linked to cellular senescence as well as predisposition to malignant transformation. Study Objective was to assess leucocytic DNA telomere length in hepatitis C related cirrhosis pre-therapy and following viral eradication; 12 weeks after end of therapy (EOT), and healthy controls to accurately evaluate molecular changes in response to therapy.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Hepatitis C virus related hepatic cirrhosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2016
Actual trial start date 01/01/2017
Anticipated date of last follow up 01/10/2017
Actual Last follow-up date 30/12/2017
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 48
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Direct Antiviral Therapy Sofosbuvir 400 mg plus Daclatasvir 60 mg once daily oral 12 weeks Sofosbuvir 400 mg plus Daclatasvir 60 mg 24
Control Group contols: received no therapy and were HCV negative and healthy no therapy none received no therapy and were HCV negative and healthy 24 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Hepatitis C virus related cirrhosis naive concomitant Hepatitis B malignancy pregnancy renal failure 29 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
Yes 28/03/2018 alexandria Faculty of medicine ethics committee
Ethics Committee Address
Street address City Postal code Country
khartoum square, azareeta Alexandria 21544 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cure of experimental group receiving therapy before and after 12 weeks
Secondary Outcome effect on DNA telomere in experimental group before and 12 weeks and in control group measured once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University hospitals Khartoum square, azarreta Alexandria 21544 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria Faculty of Medicine khartoum square, azarreta alexandrai 21544 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Faculty of Medicine khartoum square, azarreta alexandrai 21544 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala Demerdash 75 ismail serry street, smouha alexandrai 21311 Egypt
Amany Elyamany khartoum square, azarreta alexandrai 21544 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hala demerdash demerdashh@yahoo.com +201229501257 75 ismail serry st smouha
City Postal code Country Position/Affiliation
Alexandria 21311 Egypt alexandria University hospitals
Role Name Email Phone Street address
Public Enquiries Emad Arida aridae@yahoo.com +201223129135 khartoum square,azareeta
City Postal code Country Position/Affiliation
Alexandria 21544 Egypt alexandria faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Amany El-Yamany amanyamany@yahoo.com +201223345799 khartoum square,azareeta
City Postal code Country Position/Affiliation
Alexandria 21544 Egypt alexandria faculty of medicine
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