CKD With Hepatitis C Clinical Trial
Official title:
A Prospective Study on Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy
| Verified date | October 2016 |
| Source | Institute of Liver and Biliary Sciences, India |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients 2. Patients consented for the study protocol by signing the informed consent. Exclusion Criteria: 1. Age less than 18 years 2. Confirmed pregnancy 3. HCV-HIV Co infection 4. HBV-HCV co infection |
| Country | Name | City | State |
|---|---|---|---|
| India | Institute of liver and Biliary Sciences | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Liver and Biliary Sciences, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy. | 1 year | ||
| Secondary | number of adverse Events in both groups | 2 years |