NCT03067883

Brief Summary

To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 9, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

January 23, 2017

Last Update Submit

January 17, 2018

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (1)

  • Sustained Virological Response

    The proportion of patients with a sustained virological response (HCV RNA \<25 IU/mL) 12 weeks after the last dose of study drug (SVR12).

    After 12 weeks after the last dose

Secondary Outcomes (1)

  • Treatment related withdrawal rate

    during treatment period, average duration 3 months

Study Arms (1)

interventional Qurevo group

EXPERIMENTAL

A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study. * These patients will receive intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks. * Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session). * Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ).

Drug: Ombitasvir, Paritaprevir and Ritonavir

Interventions

Ombitasvir, Paritaprevir and RitonavirDRUG

A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study. * These patients will receive an intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks. * Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session). * Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ).

Also known as: qurevo
interventional Qurevo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Under regular HD for at least 6 months
  • Clinically stable condition as outpatients.
  • Treatment naïve patients with serum positive for HCV GT4 with HCV RNA \> 1000 IU/ml by PCR.
  • White blood cell count \> 2500/mm\^3.
  • Platelet count \> 7500/mm\^3.
  • Patients categorised as having compensated cirrhosis had a diagnosis of cirrhosis based on a previous screening liver FibroTest score of 0·72 or lower (eg, Metavir Fibrosis Score \>3 \[including 3/4 or 3-4\] ).

You may not qualify if:

  • Confirmed pregnancy.
  • HCV-HIV co infection.
  • HBV-HCV co infection.
  • Uncontrolled hyper or hypothyroidism.
  • For patients without cirrhosis, Patients will be excluded if alanine or aspartate aminotransferase more than five times the upper limit of normal, for patients with cirrhosis they will be excluded if alanine or aspartate aminotransferase are higher than seven times the upper limit of normal
  • Patients on peritoneal dialysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maadi armed forces hospital

Cairo, Maadi, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

ombitasvirparitaprevirRitonavir

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mai Mohamed Naguib Abd Elmen'em, B.pharm

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, cohort, open label trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 23, 2017

First Posted

March 1, 2017

Study Start

November 9, 2016

Primary Completion

January 1, 2018

Study Completion

July 1, 2018

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

EG(1)