NCT03341988

Brief Summary

  1. 1.To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in chronic HCV infected patients in those with CKD versus ESRD in Assiut Hospital University .
  2. 2.Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD versus ESRD in Assiut Hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

November 22, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

1 month

First QC Date

October 2, 2017

Last Update Submit

May 18, 2018

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the sustained viral response of Ombitasvir/Paritaprevir/Ritonavir regimen in the treatment of Chronic HCV patients in CKD versus ESRD patients in Assiut University Hospital

    pathologic complete remission for HCV after tretment

    6 months

Study Arms (1)

Ombitasvir (25 mg ), Paritaprevir (150 mg ) once daily

OTHER

Ombitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily)Ribavirin (RBV): weight-based and divided bid (1000 mg/day if \< 75kg or 1200 mg/day if ≥ 75kg) given to 50 chronic HCV infected patients with renal impairment for 12 week

Drug: Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram

Interventions

Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligramDRUG

To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in ch HCV infected patients in those with CKD vs ESRD 2- Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD vs ESRD

Ombitasvir (25 mg ), Paritaprevir (150 mg ) once daily

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patients aged from18- 60 years.
  • Chronic HCV infection with Plasma HCV RNA greater than 15,000 IU/mL
  • Treatment naïve.
  • compensated liver cirrhosis.
  • Absence of coinfection with HBV or HIV.

You may not qualify if:

  • Patients with hepatitis B virus or HIV.
  • prior antiviral therapy.
  • Haemoglobin level less than 10mg/dl.
  • Decompensated liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (4)

  • Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot-Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20;385(9986):2502-9. doi: 10.1016/S0140-6736(15)60159-3. Epub 2015 Mar 31.

    PMID: 25837829BACKGROUND

  • Zhang J, Nguyen D, Hu KQ. Chronic Hepatitis C Virus Infection: A Review of Current Direct-Acting Antiviral Treatment Strategies. N Am J Med Sci (Boston). 2016 Apr;9(2):47-54. Epub 2016 Apr 27.

    PMID: 27293521BACKGROUND

  • Kandeel A, Genedy M, El-Refai S, Funk AL, Fontanet A, Talaat M. The prevalence of hepatitis C virus infection in Egypt 2015: implications for future policy on prevention and treatment. Liver Int. 2017 Jan;37(1):45-53. doi: 10.1111/liv.13186. Epub 2016 Jun 30.

    PMID: 27275625BACKGROUND

  • Mekky MA, Abdel-Malek MO, Osman HA, Abdel-Aziz EM, Hashim AA, Hetta HF, Morsy KH. Efficacy of ombitasvir/paritaprevir/ritonavir/ribavirin in management of HCV genotype 4 and end-stage kidney disease. Clin Res Hepatol Gastroenterol. 2019 Feb;43(1):82-87. doi: 10.1016/j.clinre.2018.08.003. Epub 2018 Aug 27.

    PMID: 30166253DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Hala Elsherif, Professor

    Assiut University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

October 2, 2017

First Posted

November 14, 2017

Study Start

November 22, 2017

Primary Completion

January 1, 2018

Study Completion

May 1, 2018

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

EG(1)