A prospective, interventional, multi-center trial to evaluate the Efficacy and Safety of Sofosbuvir-Velpatasvir for the treatment of Chronic Hepatitis C patients in Pakistan.
To evaluate the safety & efficacy of Sofosbuvir-Velpatasvir combination in real world setting in Pakistan. Further, this study aims to assess sustained virologic response at 12 weeks after the end of therapy.
Design
prospective, open label, single arm, intervention & multi center trial.
Settings and conduct
Study is to be conducted at Gastroenterology department in Jinnah Post-graduate Medical center Karachi, Jinnah Hospital Lahore, Gulab Devi Hospital Lahore, Hayatabad Medical Complex Peshawar, and Pakistan Institute of Medical Sciences, Islamabad, Pakistan. Hepatitis-C patients visiting gastroenterology department of the mentioned institutes would be enrolled after meeting selection criteria. Treatment naive or treatment experienced patients would be prescribed sofosbuvir-velpatasvir combination for 12 weeks as per physician's discretion. Patients would be followed at week 04, week 12 and week 24 of the baseline visit.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Subjects willing to undergo screening and sign informed consent. Male or female outpatients ≥18 years of age. Serologically and histologically proven CHC, detectable HCV RNA, elevated ALT, and compensated liver disease.
Exclusion Criteria: Unable to give written informed consent. Pregnant and/or Nursing Women. Contraindicated to medicine or any of the component of prescribed therapy
Primary Outcome: Sustained Virologic Response (SVR) assessed at week 24 from baseline visit through HCV-RNA PCR. Secondary Outcome: End of treatment response (ETR) would be assessed at week 12 from baseline visit through HCV-RNA PCR.
General information
Reason for update
Acronym
CAVES-IT
IRCT registration information
IRCT registration number:IRCT20170614034526N4
Registration date:2019-03-28, 1398/01/08
Registration timing:retrospective
Last update:2019-03-28, 1398/01/08
Update count:1
Registration date
2019-03-28, 1398/01/08
Registrant information
Name
Dr. Sharib Syed Muhammad
Name of organization / entity
Hilton Pharma Pvt Ltd
Country
Pakistan
Phone
(021) 111-123-000 Ext:428
Email address
sharibsyed@hiltonpharma.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-02, 1397/01/13
Expected recruitment end date
2018-06-30, 1397/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A prospective, interventional, multi-center trial to evaluate the Efficacy and Safety of Sofosbuvir-Velpatasvir for the treatment of Chronic Hepatitis C patients in Pakistan.
Public title
Efficacy & Safety of Velpatasvir-Sofosbuvir combination in treatment of Hepatitis-C patients of Pakistan, Phase-IV Interventional Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects willing to undergo screening and sign informed consent
Male or female outpatients ≥18 years of age
Serologically and histologically proven CHC, detectable HCV RNA, elevated ALT, and compensated liver disease.
Exclusion criteria:
Unable to give written informed consent
Pregnant and/or Nursing Women
Contraindicated to medicine or any of the component of prescribed therapy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
155
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jinnah Postgraduate Medical Center
Street address
Rafiqui Shaheed Road, Near National Institute of Child Health (NICH,
City
Karachi
Postal code
75510
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
F.2-81-IRB/2018-GENL/7065/JPMC
Health conditions studied
1
Description of health condition studied
Chronic Hepatitis-C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
Sustained Virologic Response (SVR)
Timepoint
Assessed at week 24 from the baseline visit or start of therapy
Method of measurement
HCV-RNA PCR
Secondary outcomes
1
Description
End of Treatment Response (ETR)
Timepoint
assessed at week 12 from baseline visit or start of therapy.