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

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ClinicalTrials.gov Identifier: NCT03549832
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Sohag University
South Valley University
Information provided by (Responsible Party):
Mohamed Abdelsabour Mekky, Assiut University

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.

Condition or disease Intervention/treatment Phase
HCV Coinfection Drug: Sofosbuvir Drug: Simeprevir Drug: Daclatasvir Drug: Ribavirin Drug: Ombitasvir/paritaprevir/ritonavir Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: sof/sim/dac
Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
Drug: Sofosbuvir
Sofosbuvir 400 mg oral pills

Drug: Simeprevir
Simeprevir 150 mg oral pills

Drug: Daclatasvir
Daclatasvir 60 mg oral pills

Drug: Ribavirin
Ribavirin 200 mg oral pills

Active Comparator: sof/omb/parit
Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin
Drug: Sofosbuvir
Sofosbuvir 400 mg oral pills

Drug: Ribavirin
Ribavirin 200 mg oral pills

Drug: Ombitasvir/paritaprevir/ritonavir
Ombitasvir/paritaprevir/ritonavir oral pills




Primary Outcome Measures :
  1. SVR rate [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549832


Locations
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Egypt
Assiut University Hopsital
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
Sohag University
South Valley University
Investigators
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Study Director: Mohamed Mekky, MD Assiut University

Publications of Results:
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Responsible Party: Mohamed Abdelsabour Mekky, Ass. Professor, Assiut University
ClinicalTrials.gov Identifier: NCT03549832     History of Changes
Other Study ID Numbers: IRB17300204
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Mohamed Abdelsabour Mekky, Assiut University:
HCV
DAAs
Non-responder

Additional relevant MeSH terms:
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Coinfection
Infection
Virus Diseases
Parasitic Diseases
Ribavirin
Ritonavir
Sofosbuvir
Simeprevir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors