Status:
COMPLETED
Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients
Lead Sponsor:
Beni-Suef University
Conditions:
Chronic Hepatitis C Virus Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus ...
Detailed Description
A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treate...
Eligibility Criteria
Inclusion
- Participants with plasma HCV RNA level \>10,000 IU/L for the two groups.
- Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
- Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV
Exclusion
- coinfected with hepatitis B virus or human immunodeficiency virus infection,
- any cause of liver disease other than HCV GT4 infection;
- liver decompensation,
- hepatocellular carcinoma,
- major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C \>9)
- Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count \<50,000 cells/mm3)
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT04385407
Start Date
April 1 2015
End Date
July 1 2016
Last Update
May 12 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.