Status:
TERMINATED
Re-treatment of HCV Following DAA Failure
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Collaborating Sponsors:
Ram Manohar Lohia Institute of Medical Sciences, Lucknow
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
HCV infection is treated with oral drugs, termed as 'direct-acting anti-viral agents' (DAAs). In India, four DAAs are available (sofosbuvir \[SOF\], daclatasvir \[DCV\], ledipasvir \[LDV\] and velpata...
Detailed Description
-Introduction Oral drugs, termed collectively as 'Direct-acting anti-viral agents' (DAAs), are the standard-of-care for HCV treatment. In India, four DAAs, namely sofosbuvir (SOF), daclatasvir (DCV), ...
Eligibility Criteria
Inclusion
- participants with chronic HCV infection and viremia, who have completed the DAA-based standard treatment and relapsed
- regardless of severity of liver disease, HCV genotype, nature or duration of DAAs,and whether treatment-naïve or previously treated with Peg-IFN/ribavirin
Exclusion
- Participants with chronic kidney disease
- Post-organ transplant recipients
- Short life expectancy (\<1 year)
- Not willing to follow-up
- Individuals with immunocompromised states: HIV, immunosuppressive drugs, cancer chemotherapy, congenital hemolytic anemia
Key Trial Info
Start Date :
February 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03483987
Start Date
February 10 2018
End Date
April 30 2022
Last Update
May 10 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014
2
RML Institute of Medical Sciences
Lucknow, Uttar Pradesh, India