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Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

Primary Purpose

HCV Coinfection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sofosbuvir
Simeprevir
Daclatasvir
Ribavirin
Ombitasvir/paritaprevir/ritonavir
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV Coinfection focused on measuring HCV, DAAs, Non-responder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with proven CHC genotype 4
  • 18 years old or more,
  • prior HCV treatment failure to sofosbuvir /daclatasvir
  • compensated liver disease.

Exclusion Criteria:

  • Patients with combined HCV/HBV co-infection, hepatocellular carcinoma (HCC), decompensated liver cirrhosis (Child-Pugh score above 6), and non-genotype 4 were excluded.

Sites / Locations

  • Assiut University Hopsital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

sof/sim/dac

sof/omb/parit

Arm Description

Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin

Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin

Outcomes

Primary Outcome Measures

SVR rate
The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment. The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2018
Last Updated
March 17, 2019
Sponsor
Assiut University
Collaborators
Sohag University, South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT03549832
Brief Title
Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure
Official Title
Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
Sohag University, South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.
Detailed Description
HCV management with new DAAs is now promising. However, many cases reporting treatment failure either non-responder or relapse to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in a multicenter open-labeled randomized trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Coinfection
Keywords
HCV, DAAs, Non-responder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sof/sim/dac
Arm Type
Active Comparator
Arm Description
Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
Arm Title
sof/omb/parit
Arm Type
Active Comparator
Arm Description
Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Intervention Description
Sofosbuvir 400 mg oral pills
Intervention Type
Drug
Intervention Name(s)
Simeprevir
Intervention Description
Simeprevir 150 mg oral pills
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Intervention Description
Daclatasvir 60 mg oral pills
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
Ribavirin 200 mg oral pills
Intervention Type
Drug
Intervention Name(s)
Ombitasvir/paritaprevir/ritonavir
Intervention Description
Ombitasvir/paritaprevir/ritonavir oral pills
Primary Outcome Measure Information:
Title
SVR rate
Description
The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment. The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with proven CHC genotype 4 18 years old or more, prior HCV treatment failure to sofosbuvir /daclatasvir compensated liver disease. Exclusion Criteria: Patients with combined HCV/HBV co-infection, hepatocellular carcinoma (HCC), decompensated liver cirrhosis (Child-Pugh score above 6), and non-genotype 4 were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Mekky, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University Hopsital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26083155
Citation
Gutierrez JA, Lawitz EJ, Poordad F. Interferon-free, direct-acting antiviral therapy for chronic hepatitis C. J Viral Hepat. 2015 Nov;22(11):861-70. doi: 10.1111/jvh.12422. Epub 2015 Jun 17.
Results Reference
result

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Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

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