End-stage Renal Disease Clinical Trial
Official title:
Efficacy and Safety of Ombitasvir/ Paritaprevir / Ritonavir Plus Ribavirin in Management HCV Genotype 4 and End-stage Kidney Disease With or Without Hemodialysis (An Open Label- Multicenter Prospective Study)
Verified date | January 2020 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Management of patients with hepatitis C virus (HCV) related liver disease with concomitant co-morbidity was challenging, especially in the period before the era of new direct-acting antiviral (DAA) agents. With the introduction of DAAs protocols, the therapeutic options were expanded to endorse many patients that were previously assigned as difficult-to-treat population. Different situations were encountered with co-infection with HCV such as chronic kidney disease (CKD) with its spectrum from mild forms to the end-stage kidney disease (ESKD), patients on hemodialysis (HD), and in post-renal transplant settings. Till now, pooled data about the safety and efficacy of different DAAs regimens in different renal situations are still under evaluation, especially in Egypt, where HCV genotype 4 the most dominating genotype. In Egypt, there were two adopted protocols for patients with HCV and CKD; the sofosbuvir-based combinations and the ombitasvir, paritaprevir, and ritonavir plus ribavirin-based combination. Sofosbuvir was proved to be contraindicated in patients with end-stage renal diseases as its elimination based mainly on renal route that may affect its bioavailability. On the other hand, ombitasvir, paritaprevir, and ritonavir plus ribavirin regimen was proved to be a well-tolerated protocol in non-cirrhotic patients with CKD.
Status | Completed |
Enrollment | 110 |
Est. completion date | September 30, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients were 18 years old or more, - naive to HCV treatment, - HCV genotype 4, - compensated liver disease. Exclusion Criteria: - Patients with combined HCV/HBV co-infection - hepatocellular carcinoma (HCC) - decompensated liver cirrhosis (Child-Pugh score above 6) - non-genotype 4 |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University Hopsital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University | Sohag University, South Valley University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment. | 6 months | ||
Secondary | The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions. | 6 months |
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