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.: PACTR201708002452985 Date of Approval: 21/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hepatocellular carcinoma recurrence after directly acting antivirals
Official scientific title Early versus late start of directly acting antivirals regarding hepatocellular carcinoma recurrence : A randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Many trials studied the role of hepatitis C virus (HCV) eradication on the hepatocellular carcinoma (HCC) recurrence in the era of pegylated interferone. The long-term studies have found a reduction in the incidence of HCC over time as a result of switch-off the necro-inflammatory process and inflammatory cytokines, but without complete elimination of the risk and so long term follow up is warranted. In the era of directly acting antivirals (DAAs), the recent introduction of these drugs did not allow a long-term evaluation of the impact on the incidence of HCC; so, data regarding HCC recurrence after DAAs treatment are limited and debatable.Surprisingly, unlike what was expected; some reports have suggested that treatment with DAAs is associated with a higher rate of HCC recurrence.On the other hand, many other studies showed no increased risk of tumor recurrence and even the risk might be decreased on the long term. Also, time of start of antiviral therapy is claimed to influence risk of recurrence. Objectives: This randomized controlled trial will include 68 patients who will start DAAs either 4 weeks after tumor ablation (group 1) or 6 months after tumor ablation (group 2), aiming for evaluation of DAAs in the cohort of HCV induced HCC as regards the following: a) Sustained virological response (SVR). b) Rate of HCC recurrence after viral eradication in those with early HCV management (4 weeks after tumor ablation) and late HCV management (6 months after tumor ablation). (primary endpoint) c) Progression of Child-Pugh core, M ELD score, Performance status and Mortality rates. (secondary endpoints)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Hepatitis C virus, Hepatocellular carcinoma
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2017
Actual trial start date 31/07/2017
Anticipated date of last follow up 05/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 using a radomisation table created by a computer software program non blinded Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group late initiation of antivirals for HCV Late start of directly acting antivirals 34
Control Group Early initiation of Antivirals for HCV Early start of directly acting antivirals 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Child-Pugh class is A or B. 2- With either single HCC lesion less than 5 cm or ¿ 3 lesions less than 3 cm. 3- total ablation of Hcc lesion(s) using radiofrequency or microwave ablation. 1-Positive HBsAg. 2-History of alcohol consumption 3-Patients with other known causes of chronic liver disease. 4-Patients who have received previous locoregional treatment for HCC. 5-Patients with previous exposure to directly acting antivirals for hepatitis C virus. 18 Year(s) 80 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 15/06/2017 The Ethics Committee of the Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
17 Champollion street Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome sustained virological response 12 weeks after end of antiviral therapy for HCV
Primary Outcome rate of hepatocellular carcinoma recurrence after antiviral therapy for HCV 1 and 2 years after tumor ablation
Secondary Outcome Changes in Child Pugh score, MELD score and performance status. 1 and 2 years after tumor ablation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Facuty of Medicine, Hepatology Unit 1 Khartoum square Alexandria 21131 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria Faculty of Medicine 1 Khartoum square Alexandria 21131 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Main University hospital 1 Khartoum square Alexandria 21131 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amr Aly Abd Elmoety 1 Khartoum square Alexandria 21131 Egypt
Mohammed Shater 1 Khartoum square Alexandria 21131 Egypt
Sameh Lashen 1 Khartoum square Alexandria 21131 Egypt
Yousri Rostom 1 Khartoum square Alexandria 21131 Egypt
Ahmed Kamal 1 Khartoum square Alexandria 21131 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Kamal ahmed.kamal.med.scientific@gmail.com +201279734654 1 Khartoum square
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Ahmed Kamal ahmed.kamal.med.scientific@gmail.com +201279734654 1 Khartoum square
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Ahmed Kamal ahmed.kamal.med.scientific@gmail.com +201279734654 1 Khartoum square
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Assistant lecturer
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