Home » Trials » SLCTR/2017/007
Effect of combination therapy of Pegylated interferon- Alpha 2a, Sofosbuvir and Ribavirin for 12 weeks versus combination of Sofosbuvir and Ribavirin for 24 weeks on viral loads in Hepatitis C Virus (HCV) Genotype 3 chronic hepatitis & compensated cirrhosis patients
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SLCTR Registration Number
SLCTR/2017/007
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effect of combination therapy of Pegylated interferon- Alpha 2a, Sofosbuvir and Ribavirin for 12 weeks versus combination of Sofosbuvir and Ribavirin for 24 weeks on viral loads in Hepatitis C Virus (HCV) Genotype 3 chronic hepatitis & compensated cirrhosis patients
Public Title of Trial
Effect of combination therapy of Pegylated interferon- Alpha 2a, Sofosbuvir and Ribavirin for 12 weeks versus combination of Sofosbuvir and Ribavirin for 24 weeks on viral loads in HCV Genotype 3 chronic hepatitis & compensated cirrhosis patients
Disease or Health Condition(s) Studied
HCV genotype 3 related chronic hepatitis & compensated cirrhosis
Scientific Acronym
BSMMUHCV study (BangaBandhu Sheikh Mujib Medical University Hepatitis C virus study)
Public Acronym
BSMMUHCV (Banga Bandhu Sheikh Mujib Medical University Hepatitis C virus study)
Brief title
None
Universal Trial Number
U1111-1185-7598
Any other number(s) assigned to the trial and issuing authority
BSMMU/2016/1951 (ERC: Bangabandhu Sheikh Mujib Medical University)
What is the research question being addressed?
What is the difference in treatment outcome as determined by SVR12 of combination therapy of weekly Pegylated Interferon alpha-2A, Daily Tablet Sofosbuvir and weight based Ribavirin for 12 weeks versus Daily Tablet Sofosbuvir and Weight based Ribavirin for 24 weeks in HCV genotype 3 associated Chronic Hepatitis and Compensated Cirrhosis patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out at the Hepatology Department of BSMMU, Dhaka. Consenting participants meeting inclusion/exclusion criteria will be randomized into 2 arms using simple randomization
Arm A will receive the following regimen for 12 weeks
1. Pegylated Interferon Alpha 2a 180 micro gram subcutaneously, weekly.
2. Oral Sofosbuvir 400 mg daily
3. Capsule Ribavirin 1000mg/daily for weight <70kg, & 1200 mg/day for weight >70 kg.
Arm B will receive the following regimen for 24 weeks
1.Oral Sofosbuvir 400 mg daily
2. Capsule Ribavirin 1000mg/daily for weight <70kg, & 1200 mg/day for weight >70 kg.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Sustained virological response at 12 weeks (SVR 12, defined as undetectability of HCV viral load in blood for 12 consecutive weeks) |
[ At baseline, 28 days after commencement of treatment (RVR), at the end of treatment (ETR) and 12 weeks from the completion of treatment (SVR12) ] |
Secondary outcome(s)
|
1.
Major adverse effects |
[ Arm A will be assessed at 1, 2, 4, 8, 12 and 24 weeks, arm B will be assessed at 1, 2, 4, 8, 12, 24 and 36 weeks ] |
|
2.
HCV RNA (viral load) |
[ Arm A will be assessed at 0, 4, 12 and 24 weeks and Arm B will be assessed at 0, 4, 24 and 36 weeks ] |
|
3.
Complications such as anemia, bleeding manifestations or features of decompensation such as edema, jaundice, ascites and encephalopathy |
[] |
Target number/sample size
30 (15 in each arm)
Countries of recruitment
Anticipated start date
2017-04-01
Anticipated end date
2017-12-31
Date of first enrollment
2017-04-01
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-01-24
Approval number
BSMMU/2016/1951
Details of Ethics Review Committee
| Name: | Institutional Review Board (IRB) of the Bangabandhu Sheikh Mujib Medical University |
| Institutional Address: | Shahbag, Dhaka, Bangladesh |
| Telephone: | +880-9661064 |
| Email: | registrar@bsmmu.edu.bd |
Contact person for Scientific Queries/Principal Investigator
Mainuddin Ahmed
Resident, Department of Hepatology
Bangabandhu Sheikh Mujib Medical University,
Dhaka, Bangladesh
Mob: +8801714072922
mainuddinbm13@gmail.com
Contact Person for Public Queries
Prof Salimur Rahman
Professor Department of Hepatology Course Director Medicine and Allied
Bangabandhu Sheikh Mujib Medical University,
Dhaka, Bangladesh
Tel: +8801711523714
salimur51@yahoo.com
Primary study sponsor/organization
Department of Hepatology Bangabandhu Sheikh Mujib Medical University
Shahbag, Dhaka-1000
Bangladesh
Tel: +88 02 55165760-94
http://www.bsmmu.edu.bd/index.php?module=dp&dp=6&trg=139028968042
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
