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Effect Of DAAs For Treatment Of HCV On Normal Kidney

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ClinicalTrials.gov Identifier: NCT03296930
Recruitment Status : Unknown
Verified September 2017 by Hazem shoman, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Hazem shoman, Assiut University

Tracking Information
First Submitted Date  ICMJE September 16, 2017
First Posted Date  ICMJE September 29, 2017
Last Update Posted Date September 29, 2017
Estimated Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
Effect of the direct acting antiviral agents used for HCV treatment on the function of the normal kidney by measurement of serum creatinine. [ Time Frame: one year ]
assessment of the renal toxicity of direct acting antivirals used for HCV treatment by measurement of the serum creatinine to detect any deviation beyond the normal values.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect Of DAAs For Treatment Of HCV On Normal Kidney
Official Title  ICMJE Effect Of Interferon-Free Direct Acting Antiviral Agents For Treatment Of Hepatitis C Virus Patients On The Normal Kidney
Brief Summary The aim of the study is to determine the effect of different direct acting antiviral drugs used for treatment of chronic HCV infected patients on normal kidney.
Detailed Description

Hepatitis C virus (HCV) infection is a major health problem. The World Health Organization (WHO) estimated that at least 150-170 million people, approximately 3% of the world's population, are chronically infected. These patients are known to be at risk of developing liver complications, i.e., cirrhosis and liver cancer, with an estimated liver-related mortality of 350,000 people/year. However, the risks of morbidity and mortality are underestimated because they do not take into account the extra-hepatic consequences of HCV infection. Numerous extra-hepatic manifestations (HCV-EHMs) have been reported. In some large cohort studies, up to 74% of patients experienced HCV-EHMs of different severity, from perceived to disabling conditions.

Treatment of HCV infection has a long history. It began with interferon (IFN) mono-therapy, with less than 20% sustained virological response (SVR). Milestones include the addition of ribavirin (RBV) to the treatment protocol and providing pegylated-IFN (PegIFN) as an alternative treatment.

Treatment with PegIFN/RBV was the standard of care for about 10 years. The success rate of treatment with this regimen is very dependent on patient characteristics, including age, body mass index, ethnicity, and genetic factors.

Viral factors, especially HCV genotype, also affect the response to HCV treatment, and there are always additional factors that should be taken into account in each treatment approach, including treatment success rate, duration, cost, and side effects.

In light of these concerns, attempts have continued to introduce better therapeutic regimens.

Treatment of chronic HCV infection has been revolutionized in recent years. The FDA has approved different IFN-free direct acting antiviral regimens (DAAs) including: Sofosbuvir (SOF) in combination with Ledipasvir (LDV), combination of Ombitasvir/Paritaprevir/ Dasabuvir (a three direct acting antiviral, or 3D), combination therapy with Grazoprevir/Elbasvir (GZR/EBR), Simeprevir (SMV) and Daclatasvir (DCV) also in combination with SOF.

More than 95% of patients have a sustained viral response (SVR) using DAA. The recent Cohort studies have demonstrated that the new regimens of DAAs may be associated with renal side effects, especially when using SOF combinations. So, to aid in the correct use of DAAs in treatment of HCV patients, their potential renal toxicity must be known.

The close monitoring of renal function is required. Although, new DAAs were well tolerated, recent real-life studies have demonstrated some nephrotoxic effect in Frail populations treated with SOF based regimens.

The use of direct acting antiviral agents (DAAs) in HCV patients might be expected to result in improved outcomes in hepatic functions even in end stage liver disease. But, the effect of DAAs on the kidney still needing a specific study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Antiviral Drug Adverse Reaction
Intervention  ICMJE
  • Drug: Sofosbuvir 400 MG Oral Tablet,
    Interferon free direct acting antiviral drugs used for treatment of HCV.
    Other Names:
    • daclatasvir
    • ribavirin
  • Drug: Ombitasvir/paritaprevir/ritonavir
    Interferon free direct acting antiviral drugs used for treatment of HCV.
    Other Name: ribavirin
Study Arms  ICMJE
  • Active Comparator: first drug group
    Sofosbuvir 400 MG Oral Tablet
    Intervention: Drug: Sofosbuvir 400 MG Oral Tablet,
  • Active Comparator: second drug group
    Ombitasvir/paritaprevir/ritonavir
    Intervention: Drug: Ombitasvir/paritaprevir/ritonavir
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 26, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2018
Estimated Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Both male and female patients with age above 18 years presented with chronic HCV infection (diagnosed by HCV RNA positive) with normal kidney functions, i.e.:

    • Normal S.creatinine
    • Normal urine analysis (without proteinuria, haematuria or abnormal casts).
    • Normal renal sonography.
  • and candidate for direct acting antiviral drugs.

Exclusion Criteria:

  • Any chronic HCV patient with known renal disease.
  • Patients with abnormal kidney functions, i.e.:

    • Abnormal S.creatinine.
    • Abnormal urine analysis (with proteinuria, haematuria or abnormal casts).
    • Abnormal renal US
  • Any other known renal disease (lupus nephritis, diabetic nephropathy).
  • Severe co-morbidity as severe heart failure or malignancy.
  • Other liver disease (autoimmune hepatitis, HBV, Wilson, ……).
  • Decompansated liver disease (ascites, hepatic encephalopathy, …).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03296930
Other Study ID Numbers  ICMJE DAAs on Normal Kidney
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hazem shoman, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zainelabdeen A Sayed, MD Assistant Professor of Internal Medicine
Study Chair: Mohammed M Abdallah, MD Professor of Internal Medicine
PRS Account Assiut University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP