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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 -

SLCTR Registration Number

SLCTR/2017/007


Date of Registration

21 Mar 2017

The date of last modification

Mar 21, 2017



Application Summary


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 of 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 Trail Number

U1111-1185-7598


Any other number(s) assigned to the trial and issuing authority

BSMMU/2016/1951 (ERC: Bangabandhu Sheikh Mujib Medical University)


Trial Details


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


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

  1. Age more than 18 years
  2. Hepatitis C Virus (HCV) genotype 3
  3. Chronic hepatitis/ Compensated Cirrhosis
  4. Detectable HCV RNA in blood
  5. Platelet count >90,000 /cmm

Exclusion criteria

  1. Decompensated cirrhosis
  2. Co-infected with Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV)
  3. Hepatocellular carcinoma
  4. Pregnancy


Primary outcome(s)

Sustained virological response at 12 weeks (SVR 12, defined as undetectability of HCV viral load in blood for 12 consecutive weeks)


Primary outcome(s) - Time of assessment(s)

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

  1. Major adverse effects
    i. Any hypersensitivity reaction (determined through patient reports and/or hospital admissions
    ii. Bone marrow suppression (leucopenia, anaemia, thrombocytopenia or pancytopenia as determined by full blood count)
    iii.Sepsis or major infection (determined clinically)

  2. HCV RNA (viral load)
  3. Complications such as anemia, bleeding manifestations or features of decompensation such as edema, jaundice, ascites and encephalopathy

Secondary outcome(s) - Time of assessment(s)

  1. Major adverse effects
    i. Any hypersensitivity reaction (determined through patient reports and/or hospital admissions
    ii. Bone marrow suppression (leucopenia, anaemia, thrombocytopenia or pancytopenia as determined by full blood count)
    iii.Sepsis or major infection (determined clinically)

  2. HCV RNA (viral load)
  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


Recruitment status

Pending


State of ethics review approval

Approved by the institutional review board (IRB) of the Bangabandhu Sheikh Mujib Medical University (Ref: BSMMU/2016/1951


Funding source

None



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None